This role is part of the Site Contracts management team within the larger Performance Operational Capabilities (POC) department that is accountable for the execution of clinical trial agreements between Biogen and study sites. Included in the remit of the group are activities to support GCO's compliance with Biogen financial policies, investigator fee budget creation and review, oversight of the site budget negotiation process, financial transparency (FT) reporting (Sunshine and EFPIA) and timely payments to clinical sites.
The Associate Director, Clinical Financial Operations, SCM coordinates in-house financial operations and provides support at the study planning stage, as well as throughout the lifecycle of a clinical trial through oversight and development of improved processes, guidelines and strategy related to the site budget creation, adherence to Fair Market Value principles (FMV),administration of site payments and compliance with financial transparency reporting requirements.
The Associate Director, Clinical Financial Operations, SCM has relationship management and performance oversight responsibilities for Biogen's Strategic Partner & Legacy CROs with a specific focus on site budgets, payments and financial transparency reporting. The Associate Director, Financial Operations, SCM's responsibilities may include the functional management of third-party site payment vendors.
The Associate Director, Financial Operations, SCM's responsibilities include the management of employee direct reports and the functional management of FSP analysts.
Business needs within the SCM group may require the Associate Director, Financial Operations, SCM to take on other financial/budget related supporting activities to ensure smooth and efficient functioning of the SCM group.
The Associate Director, Clinical Financial Operations, SCM has the following responsibilities:
The Associate Director, Financial Operations, SCM provides consistent financial strategy, oversight, and support at both the study and program level for all operating models (Strategic CRO Partner(s), Legacy CROs and/or in-house operating model) by:
Offering up-front and ongoing financial strategic planning specific to the program and needs of individual studies
Overseeing the development and approval of global investigator site budgets
Monitoring controlled process documents for compliance with Biogen policies and changes in laws and regulations
Devising, developing, and continually enhancing a robust budget development strategy, ensuring consistency across the portfolio
Overseeing the global site payment process
Serving as a point of contact to address site contract tax-related matters in collaboration with corporate tax team
The Associate Director, Financial Operations, SCM serves as the subject matter expert for budget operations by:
Providing budget oversight by:
Managing issues, risks, challenges and evaluation of investigator site budget escalations
Overseeing responses to budget escalations, analyzing trends and formulating innovative solutions
Providing site budget negotiation support and consultation
Overseeing development and reporting of Budget Hub metrics
Collaborating with external stakeholders to ensure sound process and policy in investigator budget development
Developing process and resourcing plans for internal budget activities
Reviewing and approving budget guidance documents
Developing and overseeing processes to ensure adherence to fair market value principles.
Maintaining oversight of Strategic Partner & Legacy CROs and third party site payment vendors' site payment processes by:
Managing and overseeing third party site payment vendors, if applicable
Auditing Investigator payments made by Strategic Partner and Legacy CROs to ensure timeliness, accuracy, and compliance with terms of CTA and applicable laws and regulations
Monitoring site payment processes for effectiveness and compliance with contractual commitments
Utilizing site payment metrics for analysis, reporting, compliance and process improvement
Participation in monthly governance meetings with CROs and/or third party vendors, as applicable.
Developing metrics reporting and review to support process improvement efforts
The Associate Director, Financial Operations, SCM supports FT reporting for GCO by:
Accountability for the coordination of process with external GCO FT vendors
Overseeing the GCO FT team's review and reporting responsibilities
Coordinating process improvements to improve data collection and analysis
Collaborating with external stakeholders to ensure sound process and policy in FT reporting
Responding to internal questions regarding GCO FT compliance
Support annual GCO FT reporting
A minimum of 10 years' experience in the biotechnology/pharmaceutical industry within the site contracting space and fully proficient in project management, CRO oversight and budget negotiation and execution across Phase I-IV clinical trials.
Experience in Clinical Operations and have a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines.
Demonstrated leadership and project management skills.
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.
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.
Bachelor's degree required, MBA/MPA/MPH/JD (or equivalent) preferred but not required.
All your information will be kept confidential according to EEO guidelines.