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Oracle® Health Sciences ClearTrial Cloud Service Plan and Source User Guide Release 5.0 E36710-02 |
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# 31 Resource Descriptions

This chapter describes the ClearTrial system-defined resources. ClearTrial resources represent job titles, or types of employees, who may be expected to perform work during a study.

ClearTrial multiplies the hourly rate supplied for each resource by the number of hours calculated to be necessary for employees of this type to complete the work.

The Billing Rates feature allows you to define hourly billing rates for each resource for specific service providers you may assign to work on a study.

To help guide you in providing the appropriate hourly rates you have negotiated with your vendor(s), this chapter describes the responsibilities of each resource.

## 31.1 Resource Descriptions

Described below are resources and their responsibilities.

### 31.1.1 CR01 - Clinical Research Associate (CRA)

- Supports negotiations with the central laboratory, if applicable, for costs, billing, and other details regarding the central labs involvement in the study.

- Assists with establishing the Data Safety Monitoring Board, which requires meeting schedules, report formats for receipt of safety data, etc.

- Supports the production and distribution of the subject information video (where required).

- Participates in the development of necessary documents for the study, such as forms for monitoring and site management.

- Performs an initial review of the protocol.

- Supports the Medical Writing team with writing the initial Investigator Brochure (IB).

- Participates in editing drafts of the Investigator Brochure, when a draft is provided.

- When performed in-house, translate various documents, such as the Informed Consent Form (ICF), Protocol, CRFs, IB, and Subject Diary.

- Assists in the development, distribution and collection of investigator meeting materials.

- Print and Distribute IB and Protocol.

- Produce and critique country-specific Informed Consent Forms.

- Support investigator sites with clinical trial application and exemptions, as well as IRB approvals.

- Interact with a central IRB on behalf of many sites in the study that do not require their own local IRB.

- Assist the Data Management group with the instructions for each CRF page, or the EDC equivalent, that guides the study coordinator in providing the data that is being collected.

- Attends Kick-Off, Investigator and Internal Team meetings and teleconferences as appropriate.

- Participates in identifying and screening investigators.

- Conducts on-site Pre-Study, Initiation, Monitoring and Close-out visits.

- Perform the negotiation of the investigator contract agreement and the fees to be paid per completed subject.

- Facilitate the collection of the 1572 and other regulatory documents required under the guidelines of ICH/GCP.

- Based on the study, facilitate the collection of other study documents that may be required.

- Assists the regulatory group to set up the regulatory files at the sites in accordance with GCP.

- Ensures all regulatory docs are approved and the site agreement is signed prior to drug release.

- Assists with procedures required for import, ship, certify, package, tracking and label of study drug.

- Performs monitoring visits to collect and verify data at the site against source documents.

- Perform weekly telephone contact with the study sites to check on enrollment, SAEs, and any problems, etc.

- Validates data at site to facilitate investigator and/or central lab payments.

- Supports the Project Manager in the production of periodic site newsletters.

- Resolve any questions about the CRF or EDC data with the study sites that have been raised by the data group on input of the data into the database.

### 31.1.2 CR02 - Senior Clinical Research Associate (SCRA)

In addition to activities performed by a CRA, responsibilities may include implementation and management of one or more clinical trials and project team members as appropriate.

The SCRA solves complex issues requiring in-depth analysis and provides recommendations to management.

- Supports negotiations with the central laboratory, if applicable, for costs, billing, and other details regarding the central labs involvement in the study.

- Assists with establishing the Data Safety Monitoring Board, which requires meeting schedules, report formats for receipt of safety data, etc.

- Supports the production and distribution of the subject information video (where required).

- Participates in the development of necessary documents for the study, such as forms for monitoring and site management.

- Performs an initial review of the protocol.

- Supports the Medical Writing team with writing the initial Investigator Brochure (IB).

- Participates in editing drafts of the Investigator Brochure, when a draft is provided.

- When performed in-house, translate various documents, such as the Informed Consent Form (ICF), Protocol, CRFs, IB and Subject Diary.

- Assists in the development, distribution and collection of investigator meeting materials.

- Print and Distribute IB and Protocol.

- Produce and critique country-specific Informed Consent Forms.

- Support investigator sites with clinical trial application and exemptions and IRB approvals.

- Interact with a central IRB on behalf of many sites in the study that do not require their own local IRB.

- Assist the Data Management group with the instructions for each CRF page (or the EDC equivalent) that guide the study coordinator in providing the data that is being collected.

- Attends Kick-Off, Investigator and Internal Team meetings and teleconferences as appropriate

- Participate in identifying and screening investigators.

- Conducts on-site Pre-Study, Initiation, Monitoring and Close-out visits.

- Perform the negotiation of the investigator contract agreement and the fees to be paid per completed subject.

- Facilitate the collection of the 1572 and other regulatory documents required under the guidelines of ICH/GCP.

- Based on the study, facilitate the collection of other study documents that may be required.

- Assists the regulatory group to set up the regulatory files at the sites in accordance with GCP.

- Ensures all regulatory docs are approved and the site agreement is signed prior to drug release.

- Assists with procedures required for import, ship, certify, package, tracking and label of study drug.

- Performs monitoring visits to collect and verify data at the site against source documents.

- Perform weekly telephone contact with the study sites to check on enrollment, SAEs, and any problems, etc.

- Validates data at site to facilitate investigator and or central lab payments.

- Supports the Project Manager in the production of periodic site newsletters.

- Resolve any questions about the CRF or EDC data with the study sites that have been raised by the data group on input of the data into the database.

### 31.1.3 CR03 - Regional Clinical Research Associate (Regional CRA)

Responsibilities are similar to those for a Senior CRA. Due to the regionalized nature of the role, this individual works independently and may require some additional experience.

- Provides clinical monitoring expertise, leadership, and management for clinical trials.

- Individual is responsible for the planning and delivery of the clinical component of the project in accordance with the scope of work and contracted timelines and for managing the clinical portion of the study budget.

- Coordinates monitoring activities on projects.

- Reviews site visit reports for accuracy, completion, and proper distribution in accordance with the applicable SOPs and requirements.

- Adheres to project scope-of-work guidelines, approved budget, and timelines.

### 31.1.4 CR04/CR05 - Senior Vice President Clinical or Senior Director Clinical/Therapeutic

- Strategic and tactical leader of the clinical group, accountable for the designated clinical area and for communication to corporate management.

- Leader of the project management team for assigned projects, providing input to other functions in the organization.

- Retains overall responsibility and accountability for defining the strategy and clinical operating plans for assigned projects.

- Collaborate with the development project teams for integration of the global strategy.

- Direct the selection of clinical investigators and study sites and oversee the evaluation.

- Work closely with country medical directors to incorporate the country needs and expertise into the development plans.

- Develop professional relationships with opinion and thought leaders.

- Represent the company at meetings with external attendees.

- Lead the clinical component of contract review and the due diligence process to evaluate product licensing opportunities; make recommendations on acquisitions and the work/resources required.

### 31.1.5 CR06 - Project Manager

- Responsible for management and organization of the clinical group including:

  - Define and provide direction to the group, including establishing goals, timelines, and deliverables.

  - Manage budget for the assigned group, assume responsibility for protocol design, clinical activities, and the clinical section of submissions.

  - Review and approve clinical scientific documents and SOPs, author scientific documents.

- Liaise with safety and regulatory organizations for coordination of global activities.

- Ensure the comprehensive product development plan is optimized and addresses key issues for the successful commercialization of the product (including R&D, manufacturing, and commercialization globally).

- Lead the articulation of product strategy and present/defend to the Executive Committee as required.

- Manage and execute the tactical plan supporting all elements of the product development plan and provide a detailed timeline and budget.

- Lead team to problem solve, engaging all relevant parts of the organization and escalating to appropriate higher levels within the company.

- Work effectively with overall functional leaders across the company.

- Lead the presentation of periodic budget proposals to the executive committee, including preparation of “next-year budget,” the conduct of portfolio analysis, etc.

- Assist in the preparation of study reports, investigator brochures, and publications.

### 31.1.6 CR07/CR08 - Project Admin Assistant or Secretarial Support

- Request and process legal documents. (Confidentiality and Consulting Agreements)

- Schedule meetings and prepare meeting materials, logistics, and meeting minutes.

- Prepare international and domestic travel expense reports.

- Maintain company critical records, including files pertaining to the copy approval and labeling processes, documents developed under an electronic document management system, central product file and official adverse event report and complaint files.

- Create/maintain Word documents, Excel spreadsheets, PowerPoint presentations and the company's databases.

- Maintain files, fax, and photocopy.

- Organize internal events and guest accommodations.

- Provide support for word processing; faxing, photocopying, and invoice tracking.

### 31.1.7 DM01 - Data Coordinator

- Provide solid core and some comprehensive data management expertise to data management team to provide efficient, quality data management products that meet customer needs.

- Provide leadership to the team as Lead Data Manager or in the role of back-up.

- Develop and maintain good communications and working relationships with CDM team.

- Assist other team members in training and developing data management expertise.

- Independently bring project solutions to the CDM team.

- Interact with corporate team and CDM team members to negotiate timelines and responsibilities (if desirable).

### 31.1.8 DM02 - Data Entry Clerk

- Perform clinical data entry and validation to ensure legibility, completeness, and accuracy of data.

- Assist users with requests for clinical documents.

- Assist with the development and evaluation of clinical record forms.

- Maintain internal record-keeping system(s) in conjunction with CRAs and internal staff, including maintaining and auditing data, and providing status and activity reports as required.

### 31.1.9 DM03 - Data Manager

- Provide expertise in data management.

- Lead team in data management plan development and/or act as Data Team Lead.

- Develop/maintain good communications and working relationships with Clinical and other functional teams.

- Train other team members in data management expertise.

- Attend/present at professional conferences and/or publish articles in professional journals.

- Bring project solutions to the Clinical Team.

### 31.1.10 DM04/ST03 - Senior Programmer or Statistical Programmer

- Direct, review, and manage all programming deliverables including major deliverables of analysis data sets; databases; QC plans; table, listing, and graph tracking plans; and other components of submissions.

- Direct, review and manage specifications of databases; data transfers; data definition tables; analysis files; table, listing and graph generation.

- Direct, review, and manage timelines and contracts of statistical programming activities with CROs and Sponsors in coordination with other departments.

- Attend and participate in project, departmental, and interdepartmental meetings.

- Provide programming and technical support to the principal statistician in the creation of the analysis file specifications documents.

- Develop analysis files, table, listing, and graph outputs in accordance with the statistical analysis plan (SAP) guidelines.

- Provide, as needed, QC programming support of analysis files, table, listing, and graph outputs.

- Maintain responsibility and accountability for the statistical programming integrity of various study results including ad-hoc requests, analysis files used for TLG production, TLG outputs, and various other clinical reports.

- Develop, review and maintain Global Standard Operating Procedures (SOP) for the Statistics and Data Management department.

- Understand, comply, and document compliance with Global SOPs, including training CRO personnel in statistics and data management SOPs.

- Provide programming support for ad-hoc requests from other groups, as well as, publications and other sales activities.

### 31.1.11 DM05 - Program Analyst

This position is primarily for performing SAS programming in a data management environment.

- Plan and coordinate database design, development, implementation, and maintenance.

- Support of clinical systems for local, regional, or transnational use.

- Provide technical expertise in conjunction with internal and external clients in EDC database design in support of SAS deliverables.

- Produce dataset and listing specifications.

- Reformat and restructure data for analysis.

- Program edit checks.

- Produce ad-hoc listings.

- Program transfers of data to sponsors and Biostatistics Department.

- Import data from EDC system and external vendors.

- Program, test, and document databases in accordance with programming standards and validation procedures.

- Program database manipulation and transfers of data for internal and external clients.

- May assist in developing and implementing new technologies.

- May assist IT in testing and evaluating new upgrades to technologies.

- May assist in developing, revising, and maintain core operating procedures and working instructions.

- May serve as Lead Programmer on the corporate team.

### 31.1.12 DM06 - Senior Program Analyst

- Plan and lead the development of project-related solutions for all statistical programming tasks.

- Provide technical expertise to the Statistical Programming department.

- Specific responsibilities include programming, analysis, files, tables, listings, graphs/plots and process improvement work.

- The senior program analyst may also serve as an SP lead representing Statistical Programming on the corporate team and may plan and coordinate programming, testing, and documentation of statistical programs for use in creating statistical tables, graphics, and experience-listing summaries.

### 31.1.13 DM07 - Help Desk Support Specialist

- Supervised by the Help Desk Manager.

- Provide accessible clinical hotline support in the local language.

- Prequalify the sites elected to participate in a trial based on EDC readiness.

- Verify connectivity connection and functionality of the EDC hardware/software.

- Connect sites via conference call to a designated on-call clinician when required.

- Record and document calls.

- Qualify requests that need to be escalated by gathering and confirming the necessary information to be sent to the next level.

- Assist with Inclusion/Exclusion Criteria.

- Address questions relative to the entry of data into the EDC database.

- Provide eCRF Guidance.

- Address or forward Drug/Device Questions to CRO monitoring staff.

- Provide AE and SAE Support in the absence of CRO Medical or monitoring staff.

- Address any technical issues relative to problems with data entry.

- Add new problem solutions to the knowledge database for future reference.

### 31.1.14 DM08 - Help Desk Manager

- Manage the Help Desk Support Specialist and their duties.

- Provide accessible clinical hotline support in the local language.

- Prequalify the sites elected to participate in a trial based on EDC readiness.

- Verify connectivity connection and verify functionality of the EDC hardware/software.

- Connect sites via conference call to your designated on-call clinician when required.

- Record and document calls.

- Qualify requests that need to be escalated by gathering and confirming the necessary information to be sent to the next level.

- Assist with Inclusion/Exclusion Criteria.

- Address questions relative to the entry of data into the EDC database.

- Provide eCRF Guidance.

- Address or forward Drug/Device Questions to CRO monitoring staff.

- Provide AE and SAE Support in the absence of CRO Medical or monitoring staff.

- Address any technical issues relative to problems with data entry.

- Add new problem solutions to the knowledge database for future reference.

### 31.1.15 DM09 - EDC Trainer

- Provide eLearning through web-based programs.

- Provide web-based training for individuals and/or small groups.

- Develop on-site training in a classroom setting.

- Provide customized role-based training.

- Conduct Investigator Meeting training for EDC when appropriate.

- Develop and lead “Train the Trainer” programs.

- User training management, including delivery of training certificates upon completion.

- Develop and provide instruction for Ad-hoc or customized training programs.

### 31.1.16 DS01 - Medical Monitor

- In house review of Case Report Forms (CRFs), including query resolution and addenda writing, and QA of data listings.

- Provide support for Adverse Event Reporting and/or Medical Communication, which includes writing standard and custom responses to communication requests.

- Provide in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.

- Off-label information would be disseminated at this level.

- Provide training internally and at investigator meetings on safety issues.

- Assume responsibility for serious adverse events and CRF completion.

- Write study summaries and review protocols, study summary investigator brochures, and IND annual updates for safety data verification.

### 31.1.17 GA01 - Records Clerk

- Provide technical, administrative, and clerical support for records management.

- Set-up, maintain, and track project, study, and CRF “files of record” for clinical, research, post-marketing, and regulatory affairs divisions in accordance with regulatory authority and Standard Operating Procedures (SOPs) set forth by CRO and its sponsor clients.

- Set up the project, tracking system at the beginning of a project for study, investigator and CRF page entries.

- Maintain tracking information for study and regulatory documents, correspondence submitted for filing by project staff, and CRFs delivered to CRO from CRAs following a monitoring visit.

- Maintain and provide a list of official copies of documents to specific authorized CRO personnel as they are superseded.

- Generate project specific or overall tracking reports for authorized CRO personnel.

- Maintain compliance with CRO policies and procedures, including security, safety, and general work rules.

- Attend related continuing education programs, professional meetings, and career development activities sponsored by CRO.

- Assist in assuring the secure and timely, verbal, electronic, or physical delivery of CRFs, project documents (or copies) to authorized personnel.

- At the end of the project, participate in checking inventory records, and packing and shipping project documents designated as the “files of record” to the sponsor. Monitor the retention schedule for CRO project documents.

### 31.1.18 GA02 - Records Manager

- Provide reference services to all departments and levels of personnel.

- Ensure effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures.

- Create files according to established classification system.

- Process incoming information; sort, classify and verify coded material for filing and integration into systems.

- Provide reference services to internal clients in accordance with SOPs and maintaining accurate charge-out systems.

- Create and maintain logs, computerized indexes, and databases to provide accurate status, and retrieval of information.

- Operate scanning equipment and process and organize scanned images.

### 31.1.19 Medical Writer

- Manage the preparation of clinical and pre-clinical manuscripts, abstracts, posters, slide presentations, and other scientific documents.

- Supervise the development of medical education materials and strategic marketing documents.

- Manage and review documentation generated by external communications agencies and company resources.

### 31.1.20 PK01 - Clinical Pharmacokineticist

- Provide modeling and simulation strategy and clinical development plan.

- Plan, design, analyze, and interpret PK and PK/PD data from clinical studies.

- Provide expert advice on dose/regimen selection and issues relating to clinical pharmacology (PK, PK/PD, ADME, DDI, special populations (i.e., pediatrics, hepatic and renal impairment, elderly, etc.)).

- Investigate relationships between PK and clinical endpoints, biomarkers and adverse effects; perform simulations to predict clinical response and study outcomes.

- Perform population PK and PK/PD analyses, provide interpretation and simulations.

- Interpret and present results and recommendations to management and relevant teams/committees.

- Prepare and/or review PK, PK/PD and clinical pharmacology components of study protocols, study reports, investigator's brochure, development plans, project summaries/internal documents, and regulatory briefing and submission documents.

- Prepare appropriate responses to regulatory agencies on PK, PK/PD and clinical pharmacology related issues, including regulatory advisory meetings.

- Interact cross-functionally with company departments and groups.

- Prepare, review, publish and present scientific publications and abstracts.

### 31.1.21 PK02 - Senior Pharmacokineticist

- Manage DMPK aspects of projects and negotiate an optimal PK/PD strategy for early and full development in liaison with line functions and Management.

- Responsible for PK, PK/PD, and Modeling and Simulation components of study protocols, reports, project summaries and development plans that meet regulatory requirements.

- Work across DMPK non-clinical and clinical groups to embed PK/PD into groups and projects, liaising closely with other functions supporting PK/PD.

- Preparation of submission documents and responses to Health Authority (HA) inquiries.

- Interpretation and presentation of study results to project teams and management.

- Lead appropriate PK and biopharmaceutical studies.

### 31.1.22 QA01 - Compliance/QA Manager

- Serve as a point person with all governmental regulatory organizations.

- Develop excellent working relationships that will result in rapid, worldwide approvals for internal and external (client) projects.

- Build a strong foundation for corporate credibility.

- Maintain vigilance over proposed changes and new regulatory legislation.

- Evaluate the impact of proposed changes and devise strategies and to ensure efficient regulatory functions.

- Provide regulatory assessments and conducts regulatory due diligence for new opportunities.

- Ensure optimal acceptable regulatory strategies for worldwide compliance and submissions from development through marketing, including advertising, promotion, and labeling.

- Develop and implement regulatory strategies for new products, product improvements, and new indications.

- Provide regulatory strategy and direction that will accomplish results for worldwide registrations and regulatory product maintenance activities in a positive manner.

- Help manage and participate in the processes to achieve regulatory agency input into research and development programs.

- Communicate and negotiate all activities pertaining to assigned therapeutic areas with applicable regulatory agencies to ensure efficient drug development and drug approvals.

- Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs.

- Interact with Regulatory Affairs personnel and project team members to define submission logistics and scheduling; coordinate priorities for submissions.

- Manage regulatory therapeutic areas and direct reports.

- Establish, manage, and mentor therapeutic area team.

- As a member of Regulatory Affairs management team, evaluate functional strengths and developmental areas of the department.

- Identify and recommend solutions to improve departmental efficiency and effectiveness.

- Maintain a high level of expertise through reading and attendance at professional seminars and workshops.

### 31.1.23 QA02 - Compliance/QA Auditor

- Plan, conduct, and report quality assurance audits as scheduled.

- Support QA management in promoting and assessing compliance of contracted functions with regulations, guidelines and corporate policies of CRO and customers through the conduct of independent audits of projects and processes as applicable.

- Provide quality assurance oversight, under the direction of QA management or senior staff, of assigned projects through interaction and consultation with customers, project and study teams, and associated development groups.

- Conduct GXP audits (GXP= GCP/GLP/GMP) and/or consultancy projects for customers, as applicable, according to CRO departmental and/or customer policies and procedures, within budget and agreed timelines.

- Schedule, prepare, conduct, report, and close out all assigned audits under the supervision of QA management. This may include audits of clinical study documents (protocol amendments, informed consent, clinical study reports, and advertisements) project set-up, Project In-Life, investigator sites, databases, study reports, sub-contractors, etc.

- Plan, conduct, and report audits of clinical research activities in any of the countries involved in CRO contracts to assess compliance with customer requirements, CRO core operating procedures, work instructions, and project specific guidelines/instructions.

- Participate in reviewing corrective actions.

- Represent QA on customer/project teams under the direction of QA management.

- Document and report quality/compliance issues, relating to the product, process or quality system, to line management within specified regional timelines.

- Advise/communicate to QA management the perceived need for audits of CRO systems.

- Develop a working knowledge of current GXP regulations, guidelines, and related auditing techniques.

- Assist in the conduct of customer audits, mock regulatory inspections and regulatory facility inspections.

- May host customer audits and work with responsible parties to prepare corrective action plan as applicable.

### 31.1.24 RG01 - Regulatory Submissions Specialist

- In collaboration with the Regulatory Operations team, coordinate the preparation, compilation, and publishing of global regulatory submission documents (briefing documents, INDs, CTAs, PSURs, NDAs, MAAs amendments, etc.).

- Assist with global electronic and paper records systems, to include electronic document management system.

- Assist archiving of hard-copy files in regulatory records centers in the US and the UK to include management of off-site archives.

- Help develop and maintain SOPs, work instructions, and training documents and help train others in the use of document-authoring and publishing tools.

- Work with Quality Assurance to facilitate the review and approval of documents for submission to regulatory authorities by performing QA checks on submission documents to ensure content quality and compliance with regulatory guidelines.

- Assist in maintaining regulatory registration databases and tracking systems.

- Operate as record management liaison with internal and external partners and ensure that all contractual obligations are met.

- Support the preparation of regulatory correspondence and slides for regulatory meetings.

### 31.1.25 RG02 - Regulatory Submissions Manager

- Review and approve routine regulatory submissions, including annual reports, periodic safety reports, and expedited safety reports.

- Assume primary responsibility in defining requirements, developing the content, and compiling more complex submissions, including: INDs, CTXs, NDAs, MAAs, technically complex amendments, supplements, and variations in collaboration with regulatory project leader, and regulatory operations team to be ready for review and approval.

- Serve as liaison with regulatory authority at the direction of the Director of Regulatory Affairs.

- Assume primary responsibility for assuring quality assurance of regulatory submissions, including managing the schedule for QA, Audit-CRO, and suppliers.

- Assume responsibility for providing regulatory authorization for release of clinical supplies for shipment to US study sites, if required.

- Prepare and maintain policies and SOPs for regulatory processes relative to regulatory affairs. Review and contribute regulatory perspective for SOP from other functions.

- Review and recommend protocols and development documents for approval.

- Take meeting minute notes during meetings with regulatory agencies.

- Provide regulatory input and perspective into regulatory strategies, development plans, reports, and submission documents.

- Maintain responsibility for assigned activities with the project team.

- Represent regulatory affairs in due diligence activities as required, write reports of due diligence activities, and provide recommendations.

### 31.1.26 RG03 - Director Regulatory Affairs

- Manage a Regulatory Affairs (RA) unit that provides scientific and regulatory expertise.

- Provide preclinical research, toxicology, manufacturing, and clinical trials support for both internal CRO customers and external clients, for investigational drugs, biologicals, and medical devices.

- Provide support for the development of RA business from pharmaceutical, biological and medical device companies, in accordance with the RA business plan.

- Participate in project-related work as required.

- Line management responsibilities include professional development, performance appraisals, and employee counseling for Junior Regulatory staff.

- Assigns project work and reviews workload for all direct reports.

- Takes leadership role in the coordination of products and resources.

- May serve as a team member or as a Project Manager if assigned, assures appropriate technical training will be provided to and taken by all RA unit members.

- Keeps abreast of current regulatory knowledge, trends, and developments in the US, Canada, Europe, and emerging markets.

- Participates in the RA Management Unit meetings, making reports as required.

- Provides advice to client pharmaceutical companies on developing new pharmaceutical products, including drugs and biologics.

- Interacts with FDA by phone, face to face meetings, mail, and email.

- Participates on behalf of Regulatory Affairs in business development meetings with potential clients.

- Prepares written reports and memoranda as needed.

### 31.1.27 ST01 - Junior Biostatistician

- Develop and implement programming specifications, database evaluation, and analysis plan drafting.

- Provide statistical review of program output, tables, figures, and listings resulting from the specifications.

- Provide statistical consulting for analysis file QC and generation of data listings.

- Perform statistical evaluation of databases including creation of consistency queries, summaries of database characteristics, and routine statistical summaries.

- May run non-production SAS programs to explore database characteristics in preparation for statistical analysis (upon direction of lead biostatistician).

### 31.1.28 ST02 - Senior Biostatistician

- Direct, review, and manage CROs in terms of all statistics deliverables including: major deliverables of CRFs, databases, protocols, statistical analysis and surveillance plans, data management plans, QC plans, clinical study reports, integrated summaries, and other components of submissions.

- Direct, review and manage specifications of databases, data dictionaries including coding tools, data transfers, data definition tables, analysis files and table, and listing and graphs generation.

- Direct, review, and manage timelines and contracts of statistics and data management activities with CROs in coordination with other departments.

- Attend and participate in project, departmental, and inter-departmental meetings.

- May assume responsibility for programming and data analysis of various clinical databases.

- Provide statistics and programming support for publications and other sales activities.

- Assume responsibility and accountability for the statistical integrity of various plans (including the randomization and analysis plans) and the interpretation of results as represented in clinical study reports, publications, and various other clinical reports.

- Assist with the evaluation and selection of CROs for the statistical and data management aspects of clinical studies; review contracts.

- Liaise with clinical and safety and regulatory organizations to coordinate global activities.

- Manage long-term database CRO archives following completion of projects and retrieve information as required.

- Develop, review, and maintain Global Standard Operating Procedures (SOPs) for the Statistics and Data Management department.

- Understand, comply, and document compliance with Global SOPs including training CRO personnel in the department's Statistics and Data Management SOPs.

### 31.1.29 ST04 - Director Biostatistics/Data Management

- Responsible for Data Management and biostatistics department, including P&L, quality, personnel and strategic direction.

- Manage regional Directors/Managers who are responsible for data management personnel and activities within their regions or sites.

- Assist regional Directors/Managers with planning, organizing, and resourcing projects to assume compliance with contractual obligations and to ensure optimum efficiency.

- Assist regional Directors/Managers in ensuring adherence to global standard operating procedures and working practices for all data management areas.

- Ensure all personnel related matters in Data Management are being addressed appropriately by regional Directors/Managers, including: creating position descriptions, hiring, managing, and training Data Management departmental personnel, supervising managers and senior staff, establishing performance and quality standards for Data Management, initiating personnel actions, evaluating performance of associates, and maintaining training records.

- Work collaboratively with other senior data management leaders in other countries to establish global data management processes and systems.

- Function as a member of the senior management team and assist in determining the strategic direction of the organization.

- Collaborate with management of other functional areas, including but not limited to: biostatistics, medical writing, and clinical to ensure consistency in approach and success on all projects.

- Approve Statistical and Analysis Plans.

- Support pricing, bid defenses, RFI development and capabilities presentations.

- Develop and manage sponsor relationships and partnerships.

- Work collaboratively with IT on the implementation and management of data management systems, including: establishing user requirements for data management systems, developing and executing validation plans, ensuring the development of processes to support the use of new technologies, and ensuring systems meet regulatory requirements.

- Maintain current knowledge of industry trends and information relevant to data management processes through literature reviews and attendance at industry meetings and conferences.

- Ensure staff is in compliance with all appropriate CDISC and other regulatory requirements.