Vacancy expired!
Job Description
As a Sr. Manager, Clinical Contracts, you will be part of the larger Site Contracts Management (SCM) group that is accountable for the execution of Clinical Trial Agreements between Biogen and study sites governing the conduct of clinical trials.
What You’ll Do:
- Provide strategic program and study level oversight to ensure a best-in-class approach to site contract execution for Phase I – IV clinical trials and scientific research collaborations.
- Provide leadership at the program and study planning stage, as well as throughout the lifecycle of a clinical trial.
- Develop specific study strategy and maintain oversight of Biogen’s Strategic Partner & Legacy CROs to ensure compliant and timely execution of site contracts.
- Provide critical input into the development and maintenance of processes and guidelines
- Contribute to management of the CRO relationship with a specific focus on site agreements, site budgets and site payments.
- Provide leadership on process improvement initiatives.
- Liaise with external stakeholders including Legal, Compliance, Data Management, Finance
- Be responsible for the oversight and/or management and development of assigned Site Contract Managers.
- May be required take on other site contract related supporting activities as needed (e.g., direct management of clinical trial agreement activities where a non-strategic partner / non-preferred provider CRO is engaged; management of contracts related to investigator-initiated trials and scientific research collaborations)
Qualifications
- Bachelor’s degree required, MBA/MPA/MPH/JD (or equivalent) preferred.
- 8 years’ experience in the biotechnology/pharmaceutical industry within the site contracting space and fully proficient in site contract and budget negotiation and execution across Phase I-IV clinical trials.
- Project management experience within the clinical operations space.
- Clinical Operations experience with a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
- Excellent negotiation skills, conflict resolution, decision making skills, communication (oral and written) and presentation skills.
- Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Vacancy expired!