Sr. Clinical Trial Manager

San Francisco, CA 94158 | Contract

Post Date: 04/12/2018 Job ID: 4096 Industry: Pharmaceutical

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.

 

Duties:
  • 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.


 

Skills:

  • 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.

 

Education:

  • 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.
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