The Clinical Affairs Finance & Contracts Specialist is responsible for managing the Financial and Contracting aspects of multiple regulatory (Phase I-III), post-marketing (Phase IV) and investigator initiated clinical trials (IITs). This includes developing clinical budgets, coordinating contract reviews, tracking trial payments and reporting trial expenditure. This role will work within the Clinical Affairs Department and collaborate with Anika Finance, Legal, and Compliance departments, the trial vendor team and investigational sites.
Strategic Focus Areas:
- Provide accountability to achieve Clinical Affairs financial and departmental goals, including management of clinical trial budgets & expenditure and execution of contracts to meet trial timelines and budgets.
- Ensure clinical trials budgets and payments are managed in compliance with applicable legal and industry standards.
- Act as a liaison between Anika Clinical Affairs, Finance, Legal Compliance and external stakeholders including trial vendors and investigational sites.
- Create a positive image of Anika Therapeutics through communication and interaction with key stakeholders including study investigators and vendors, as required.
- Receive, track and ensure payment of all trial related expenses including vendor and site payments for Anika clinical trials.
- Create clinical site budgets for Anika sponsored studies in accordance with Fair Market Value and industry best practices.
- Prepare draft clinical trial agreements and budgets in collaboration with Legal & Finance departments and with trial vendors & clinical trial sites as required within trial project plan.
- Coordinate cross functionally with Contract Managers, Clinical Research Organization, ancillary trial vendors, Clinical Operations, Finance and Legal departments to manage and track contracts and budget throughout trial duration.
- Maintain all internal trial budget and contract documentation as required.
- Prepare regular budget & forecasting reports for internal reviews.
Complexity associated with project planning, trial budgeting and contract tracking of clinical trials is high, and requires cross-functional expertise, knowledge and problem-solving skills. Job requires maintaining up to date knowledge of Anika clinical trials and Financial, Legal & Compliance policies and procedures. Understanding clinical trial execution along with knowledge of industry best practices for contracting and budgeting clinical trials.
- Bachelor’s degree in the life sciences or health care field
- 2 – 5 years managing clinical trial budgets within the biopharmaceutical or medical device industry.
- Experienced in clinical trial protocol review, clinical pricing, budget development, benchmarking tools and analysis, as well as industry trends and standards.
- Project management experience able to meet deadlines on multiple concurrent projects and work collaboratively with and through others.
Desired Experience, Knowledge, and Skills:
- Experienced in Clinical Trial Site Budget Development, Global Industry-Sponsored Clinical Trials, Clinical Trial Protocol Review, Clinical Trial Site Budget Escalation, Fair Market Value Assessment
- Experience in Clinical Trial contract tracking with Legal department to deliver and finalize contracts with trial vendors and investigational sites.
- Strong data analytical skills for budgeting and forecasting.
- Excellent computer skills, specifically with Microsoft Excel to manipulate and analyze large complex datasets is required
- Excellent presentation, verbal and written communication skills are required
- Demonstrated ability to collaborate, multi-task and work effectively in a fast-paced matrixed environment
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.