Position Summary
As Site Contract Manager you will be a key contributor to Ascendis’ success and value creation by ensuring fastest possible execution of clinical trial budgets and agreements with global sites participating in Ascendis’ clinical trials. You will work independently, but in close collaboration with the trial teams and Ascendis’ Legal and Finance functions to create, negotiate and follow-up on site budgets and contracts. You will report to the Director, US Clinical Operations and be part of a truly global clinical organization with locations in US, Germany and Denmark. The position is based in Palo Alto, CA.
Key responsibilities:
- Prepare, negotiate and finalize clinical site budgets and contracts
- Provide input and advise on language related to data privacy in ICFs
- Liaise with Legal Counsel and Group Compliance to confirm appropriate contract language
- Develop processes and standards to ensure contract management efficiency demonstrate this through relevant metrics
- Provide input to Ramp;D Finance for the clinical trial budgeting process
- Stay current on matters that relate to compliance with international regulations and standards pertaining to clinical development and data privacy, including the General Data Protection Regulation (GDPR) in Europe
- Contribute to Ascendis’ clinical Quality Management System
Requirements
- Minimum a bachelor’s degree in Law, Business Administration, Finance, Science or other field related to the biotechnology/pharmaceutical industry
- At least 5 years of experience with clinical site contracting; including budgets, negotiation and execution. Alternatively, at least eight years in a role related to other aspects of clinical operations
- Good understanding of clinical research from biotechnology, pharmaceutical, CRO or other health care setting
- Structured, organized and a proactive problem-solver with strong attention to detail
- Vgood planning, monitoring and negotiation skills and the abiltiy to prioritize and coordinate multiple tasks while producing quality results in a timely manner
- Assertive communication and decision making and comfortable working in global/virtual teams across time zones
- High proficiency in English
Benefits
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance