REMOTE Sr. Clinical Trial Manager

Description:

REASON FOR OPENING: Growth. This hire will be supporting a launch of a new clinical study.

We are looking for a Clinical Trial Manager with strong leadership, organizational, and communication skills to join our highly motivated and dedicated team at biotechnology company developing novel recombinant viral vector vaccines against cancer (Head & Neck) and infectious diseases.

Main Responsibilities:

• Responsible for the clinical operations and logistical aspects of assigned Phase I/II trial from start-up to close-out.

• Lead a global cross-functional Clinical Trial Team (CTT), composed of internal and external team members.

• Ensure that clinical trial deliverables are met according to timelines to achieve study goals, while meeting Good Clinical Practice (GCP) guidelines.

• Identify issues and propose solutions. Proactively assess potential risks to the clinical study and propose mitigation plans.

• Contribute to the development of clinical sections of regulatory documents such as: Investigators’ Brochures, IND/NDA submission documents, responses to Health Authorities questions.

• Management of Contract Research Organizations (CROs) supporting the clinical trial to ensure data integrity and quality.

• Supervise CRO during study start-up, such as site initiation visit (SIV) meeting planning, case report form development for database, study drug supply design and ordering, and review study site contracts and budgets.

• Provide review and input to the development of study start-up materials such as the clinical trial protocol, protocol amendment(s), Informed Consent Forms, Pharmacy Manual, Monitoring Plan, Laboratory Manual, and site training materials of the protocol.

• Collaborate with Study Medical Lead and KOLs to determine the medical and scientific needs, and apply them to the protocol and study logistics.

• Monitor the study budget; review and approve study-related invoices.

• Review site qualification reports and approve site selections.

Skills:

Vendor management, budget management, CRO, oncology, clinical research, clinical operation, clinical trial management, sop, clinical trial, Study Startup, Phase II, clinical study, document management, TMF

Top Skills Details:

Vendor management,budget management,CRO,oncology,clinical research,clinical operation,clinical trial management,sop,clinical trial

Additional Skills & Qualifications:

Must Haves:

Minimum requirement: bachelors degree in biological science, nursing, pharmacy or equivalent. Advanced degrees are a plus.

At least 5 years of experience at a pharmaceutical company, or CRO in clinical drug development.

Must have excellent oral and written communication skills, organization and tracking skills.

Experience in Clinical Vendor Management

Nice to Have:

Have knowledge of GCP, and basic understanding of clinical trial design, regulatory processes, and clinical drug development process.

Strong leadership skill, with ability to influence, motivate, and lead.

Highly motivated individual, a self-starter with minimum oversight required to accomplish goals.

Knowledge of project management skills, capable of managing multiple activities with respect to priorities.

Good command of MS-Office (Outlook, Word, Excel, PowerPoint, Project)