The Sr. Manager of Financial Operational Capabilities is responsible for financial transparency reporting for GCO spend in the US and ROW. This involves the oversight of a contractor, the management of internal and external relationships and participation in a governance structure.
This role also manages the metrics and reporting for the site contracts function through interface with internal groups and oversight of reporting.
1. Leads Site Budget Development and Administration:
• Overseeing the development and approval of global investigative site budgets (GrantPlan)
• Devising, developing, and continually enhancing a robust budget development strategy, ensuring consistency across the portfolio
• Managing issues and risks by acting as the Budget Hub SME within GCO for challenges
• Managing Budget Hub employees
• Serving as a point of contact to address site contract related tax-related matters in collaboration with corporate tax team
• Analyzing trends and formulating innovative solutions
• Overseeing development and reporting of Budget Hub metrics
2. Maintaining oversight of Strategic Partner & Legacy CROs site payment process to ensure compliant and timely payment of sites:
• Managing and overseeing third party site payment vendors
• Auditing Investigator payments made by Strategic Partner and Legacy CROs to ensure timeliness, accuracy, and compliance with terms of CTA and tax requirements
• Key representative at Site Payment Governance meetings with CROs to monitor site payment monthly meetings for effectiveness and compliance with process
• Developing strategy and policy for analysis, reporting, compliance and process improvement
• Overseeing the project management of technology implementation
• Key person to respond and work with Biogen Finance on financial matters related to site budgets
3. Lead the GCO Financial Transparency Space:
• Manage and oversee employee and contractor personnel
• Overseeing the FT vendor (Alanda) in the management of external GCO providers onboarding, data submission, communication and resolution of queries
• Review and approve data on a quarterly basis for all providers
• Conduct half-year review of data to ensure accuracy and completeness in ASR
• Assist FT team with any GCO related disputes
• Ensure that new providers and new studies are included in FT reporting
• Coordinate with Data Stewards for EFPIA compliance
• Work with CROs on process improvements towards improved data
• Respond to internal questions regarding GCO FT compliance
• Prepare annual GCO FT reporting
4. Lead Site Contracts Performance Management Support and Process Improvement by:
• Monitoring KPIs, including cycle times and SIV targets, to ensure adherence to established study timelines
• Initiating and overseeing process improvement efforts
• Monitoring Biogen's position vis a vis industry financial benchmark norms.
• Developing metrics reporting and review to support process improvement efforts
• A minimum of 8-10 years' experience in the biotechnology/pharmaceutical industry within the site contracting outsourcing space and fully proficient in project management and budget negotiation and execution across Phase I-IV clinical trials.
• 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.
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.