Job Description
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For our headquarters in all Europe we are seeking highly qualified candidates to fill the position:
Senior Manager, Site Contracts & Budget Management (m/f/x)
The Position:
The Senior Manager, SCBM Site Contracts will provide site contract management support and oversight for phase I-IV clinical trials. This role is responsible for providing program, study, and site level support for the full lifecycle of a clinical trial, providing planning, site contract strategy, escalation and resolution of contract management issues, oversight of timely and accurate site payments, and oversight of the CRO deliverables to ensure complaint and timely execution of site contracts. The position is responsible for adherence to all processes and guidelines along with the CRO relationship management with a specific focus on site contract.
This position may take on other site contract related activities including but not limited to the direct negotiation of site contracts and/or Master Clinical Trial Agreements (MCTA). Support may also extend to Scientific Research Collaborations and other associated site related agreements.
- Providing consistent and effective site contract strategy, oversight, and support to clinical trials
- Monitor KPIs Monitor KPIs, including cycle times and SIV targets, to ensure adherence to established study timelines
- Review CRO progress and work with CRO partners to mitigate site contract issues
- Collaborate with the appropriate stakeholders within and outside of GCOP, including but not limited to Study Management, CROs, Legal, Corporate Compliance, and Functional Quality groups, to ensure study specific processes and expectations are mutually well understood
- Support process documentation by supporting development of controlled documentation and guidance documents
- Involvement in functional process improvement initiatives
- Bachelor's degree in relevant field required, a Master's Degree in relevant field or equivalent combination of education, training and experience that provides the individual with the required knowledge, skills and abilities for the position preferred
- Minimum 4 years pharmaceutical/biotechnology industry experience
- Demonstrated success in working cross-functionally in a global matrix organization; minimum 2 years experience in managing or supporting global cross-functional processes
- Must have previous experience within Clinical Operations and have 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
- Proven networking skills and ability to share knowledge and experience amongst colleagues
- Excellent Benefits
- Work-Life-Balance
- Growth and Development
- Health and Wellbeing Support