Clinical Trial Manager

Company : TalentBurst, Inc.

Clinical Trial Manager
San Francisco CA, 94158
10 Months (Possible Extension)

Description:

Duties:

The Clinical Trial Manager will independently manage all components of a high complexity clinical trial, leading a multidisciplinary, cross-functional Study Management Team. The Clinical Trial Manager is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Nektar SOPs. This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities:

• Oversee and manage all aspects of a clinical trial in accordance with Nektar SOPs, ICH/GCP regulations and study-specific manuals and procedures.
• Independently lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable.
• Develop and manage effective relationships with key study stakeholders.
• Responsible for key study quality metrics (i.e., eligibility, primary endpoint data, etc.).
• Lead the identification, evaluation and hiring of appropriate CROs and other third-party study vendors in accordance with Nektar SOPs. 
• Management of CROs and other third-party vendors, including setting expectations, training, managing timelines and deliverables, and issue management.
• Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately.
• In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management when necessary.
• Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents.
• Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock.
• Project and coordinate study supply and packaging requirements.
• Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions.
• Provide weekly enrollment and program updates to senior management.
• Identify and share best practices and process improvements with colleagues to ensure optimal efficiency and consistency in Clinical Operations.
• Lead or participate in functional initiatives and/or activities as assigned.
• May mentor and develop junior clinical operations staff.

Skills:

Position Requirements:

• 8-10+ years in the pharmaceutical industry is required, including 4 years overseeing trial management. Strong experience working as a Clinical Research Associate is preferred.
• Vendor management experience required.
• Must have demonstrated problem solving abilities and strong organizational skills.
• Excellent written and verbal communication skills are required.
• Strong computer skills (MS Office) are required.
• Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required.
• Must be a demonstrated self-starter and team player with strong interpersonal skills.
• Must possess excellent cross-functional clinical project management skills.
• Demonstrated ability to develop and implement SOPs and Study Plans.
• Some travel required
• Offsite, East Coast preferred, Midwest okay

Education:

Bachelor’s degree or equivalent is required (life science degree is preferred

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