Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
SummaryThe Site Contracts and Budget Management (SCBM) group develops strategy and provides oversight to all studies in compliance with internal processes and external requirements for the following area in the study start up space - Investigator Site Contracts, Budgets and Site Payment processes. The current process is supported by CRO partners and the SCBM group is required to build an effective collaboration with our strategic alliance partnership and a process for appropriate oversight of any outsourced or contracted activities utilizing both performance and quality measurements.
The Manager, SCBM position provides site contracts and site budget related support and oversight for phase I- IV clinical trials. The Manager, SCBM is responsible for providing program, study, and site level support for the full lifecycle of a clinical trial, providing planning, budget and site contract strategy, escalation and resolution of contract and budget management issues including Fair Market Value (FMV) deviations requests, oversight of timely and accurate site payments, and oversight of the CRO deliverables to ensure complaint and timely execution of site contracts and budgets. The position is responsible for adherence to all processes and guidelines along with the CRO relationship management with a specific focus on site contracts and site budgets.
The position may take on other site contracts and budget related activities to ensure smooth and efficient functioning of the site contracts and budgets process area. Activities may include but not limited to direct site budget build (without CRO involvement) and/or direct negotiation of site contracts and/or Master Clinical Trial Agreements (MCTA). Support may also extend to Scientific Research Collaborations.
Business needs within the group may require this role to take on an increased focus on one or more of the above areas or even additional related areas to ensure Global Clinical Operations (GCO) goals are met.
- Provide consistent and effective site contract and budget strategy, oversight, and support to clinical trials by taking on the following responsibilities:
Offer up-front and ongoing strategic planning specific to the program and needs of individual studies as related to site contracts and budgets
Develop and continually enhance a robust budget development strategy, and ensure consistency across the portfolio
Oversee CROs (and or functionally outsourced vendors) for the development and approval of global investigative site budgets (via appropriate tools e.g GrantPlan)
Develop directly or provide expert input to the development of site budgets as required for the studies
Monitor and audit Investigator payments made by CROs to ensure timeliness, accuracy, and compliance with terms of Clinical Trial Agreement and tax requirements
Monitor KPIs, including cycle times and SIV targets, to ensure adherence to established study timelines
Attend Study Team meetings on an “agenda-driven” basis, i.e. when strategic decisions that impact site contracts are being discussed
Manage issues and risks by acting as a single point of contact within GCO for site contracting challenges and evaluating investigative site budget escalations and FMV deviations.
Collaborate with relevant stakeholders (e.g Regional Site Engagement Management RSEMs) to establish country level contracts strategy, monitor trends, and refine existing guidance, tools, and templates
Serving as a point of contact to address site contract related tax-related matters in collaboration with relevant DS stakeholders (e.g. corporate tax team)
Collaborate with the appropriate stakeholders within and outside of GCOP, including but not limited to GCOP Leadership, GCOP Study Management, CROs, Procurement, Legal, Corporate Compliance, Clinical Development, Global Project Management, and Functional Quality groups, to ensure study specific processes and expectations are mutually well understood
- Process Documentation and Improvement
Support build of Standard Operating Procedures and Work Instructions and ensure they are current and documented per Quality Documentation requirements and DSI process management standards
Ensure appropriate performance and quality targets are established (via metrics and KPIs) and oversight is maintained to understand target realization
Lead and/or support identification and implementation of improvements to the site contract and budget processes. Support activities include but are not limited to conduct of gap & impact assessment and developing project scope and project plans.
Work cross-functionally with stakeholders to identify when a process revision is required.
- People Management & Resource Planning–
Support development of a plan for resourcing of activities within remit/scope
Depending on business priorities, manage employee direct reports and associated employee development duties
Depending on business priorities, manage contractor-based staff in collaboration with DSI HR and vendor providers as appropriate
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- Bachelor's Degree or equivalent combination of education, training and experience that provides the individual with the required knowledge, skills, and abilities for this position. preferred
- 4 years’ relevant experience is required with a BS required
- Demonstrated success in working cross-functionally in a global matrix organization; minimum 2 years experience in managing or supporting global cross-functional processes. required
- Must have previous experience with Site Contracts and budget management. required
- Must have experience in Clinical Operations and have a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines. required
- Excellent negotiation skills, conflict resolution, decision making skills, communication (oral and written) and presentation skills. required
- Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe. required
- Proven networking skills and ability to share knowledge and experience amongst colleagues. required
TravelAbility to travel up to 20% May require travel (domestic or global)
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.