Sr. Clinical Trial Manager
455 Mission Bay Blvd. (South) San Francisco, CA 94158
Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize conjugate technology platforms, which are designed to improve the benefits of drugs for patients.
- The Senior Clinical Trial Manager will manage all components of a clinical trial, leading a multidisciplinary, cross-functional Study Management Team.
- The assigned clinical trial(s) may be high complexity or high risk.
- The Senior 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.
- Oversee and manage all aspects of a clinical trial in accordance with 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.).
- 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.
- 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.
- 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.
- Strong experience working as a Clinical Research Associate is preferred and thorough knowledge of clinical monitoring practices is required.
- Fluent English is required.
- A Bachelor’s degree or equivalent is required (life science degree is preferred).
- Typically an average of 8-10 years in the pharmaceutical industry is required, including but not limited to 4 years overseeing trial management.