Senior Clinical Program Manager

Job DescriptionJob DescriptionDescription:

• Under the direction of the VP of Clinical Affairs, the Senior Clinical Program Manager will assist and drive the oversight, implementation and running of multiple clinical studies for the purpose of generating evidence to support Business, Regulatory, Marketing, and Reimbursement objectives for VIVEX products. The Senior Clinical Program Manager will support the packaging and dissemination of evidence via the coordination and production of peer-reviewed publications, meeting presentations and white papers.

Requirements:

Duties and Responsibilities

1. Oversees the execution of studies in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.

2. Oversees CROs and other 3rd party vendors to meet obligations described in ICH-GCP and business objectives including CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.

3. Provides oversight/support/guidance to CRO to ensure study issues are addressed and resolved promptly.

4. Challenges study team to ensure operational feasibility, inclusive of patient and site burden, and timelines meet the needs of the clinical development plan.

5. Assists VP Clinical Affairs in planning and operational strategy and execution for planned clinical trials.

6. Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.

7. Assists VP Clinical Affairs in study budget planning and management and accountable for external spend related to study execution. Ensures impacts to budget are adequately addressed.

8. Liaises with project team to ensure that budgets, enrollment, and gating are accurate; tracks study status, cost and issues for communication to Program Lead(s); along with VP Clinical Affairs, serves as points of contact for third party vendors managed by CROs.

9. Reviews, in coordination with CRO and external vendors, outcomes/actions related to protocol deviations review to support the identification of trends across sites and/or the study.

10. Coordinates with CRO and external vendors to review and monitor issues, risks and decisions at the study level and implementation of appropriate mitigation strategies.

11. Coordinates with CRO and external vendors to review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data , etc.) with the tactical plan for database lock and clinical study reports.

12. Coordinates with CRO and external vendors to ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.

13. Reviews and provides expert clinical operations input into clinical documents related to the drug/biologic/medical device development process including Investigator Brochures, Investigational New Drug or Device Exemption Applications (INDs & IDEs), clinical study reports, applicable sections of the Biologic License Application (BLA) and/or Pre-Market Approval Application (PMA), and updates to these documents.

14. Provides expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2 and 3 Meetings, Request for Scientific Advice Meetings, etc.), as appropriate

15. Monitors, detects and addresses project risks through mitigation plans and alternative solutions.

16. Screens, recruits, qualifies, trains, and monitors investigators and their staff for study participation and protocol compliance (and vendors and laboratories, as applicable).

17. Coordinates the development of data outputs for written and verbal presentations of study data for symposia, scientific presentations and exhibits, and regulatory/reimbursement submissions, as appropriate.

18. Under the guidance of the VP of Clinical Affairs, develops and executes Evidence and Publication Plans for focus products. Coordinates with internal and external stakeholders on the packaging and dissemination of evidence via the production of peer-reviewed publications, meeting presentations and white papers.

19. Manages the handling of clinical study-related questions from doctors, patients, and sales force, as appropriate.

20. Other duties as assigned.

Qualifications

Bachelor’s degree or international equivalent required. Life Sciences . Master’s degree in a relevant discipline . Ten or more years’ experience in pharmaceutical or medical device industry and/or clinical research organization, including 7+ years clinical study management. Experience in more than one therapeutic area is advantageous. Excellent communication, teamwork, organizational, interpersonal, and problem-solving skills.

Working Conditions

Office Environment, Laboratory Environment.

Physical Requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Direct Reports

None

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time.

VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on , , , , , or expression, , , genetic information, , or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training.

VIVEX Biologics complies with the Americans with Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.