Manager, Site Contract and Budget Management, Financial Operations

About the position

The 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.

Responsibilities

• Provide consistent and effective site contract and budget strategy, oversight, and support to clinical trials.
• 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.
• 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 to establish country level contracts strategy, monitor trends, and refine existing guidance, tools, and templates.
• Serve as a point of contact to address site contract related tax-related matters in collaboration with relevant DS stakeholders.
• Collaborate with the appropriate stakeholders within and outside of GCOP to ensure study specific processes and expectations are mutually well understood.
• Support build of Standard Operating Procedures and Work Instructions and ensure they are current and documented per Quality Documentation requirements.
• Ensure appropriate performance and quality targets are established 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 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.

Requirements

• Bachelor's Degree required.
• 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.
• Must have previous experience with Site Contracts and budget management.
• Must have experience in 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.

Benefits

• Equal opportunity/affirmative action employer.
• Exceptional working environment that values and rewards individual contributions.
• Training, tools and technology provided to excel.
• Open communication, emphasis on results, and spirit of personal accountability.