The Contract Clinical Outsourcing Finance is responsible for assisting and managing all clinical study budget financial negotiations with external vendors and provides financial and analytical support to the R&D Finance team as well as operational business partners. Incumbent works crossfunctionally with internal departments and external resources on all Clinical Finance related issues.
The Contract Clinical Outsourcing Finance position also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description
ESSENTIAL FUNCTIONS
Primary Duties/responsibilities
Assist in Management of activities related to the outsourcing of clinical research services (CROs Labs Specialized Vendors Patient Travel Vendors DSMB vendors etc.)
Partner with operational team to Coordinate vendor identification bid defenses and vendor selection processes and ensure adherence to standardized Requests for Information (RFIs) and Requests for Proposal (RFPs)
Perform competitive bid analyses and derive recommendations to operational team leads
Negotiate services descriptions vendor budgets and payment schedules for all work orders and contracts including LOIs startup work orders SOWs change orders and amendments
Coordinate vendor award and nonaward communications
Assist in managing contracting activities in partnership with the Legal Department including preparation finalization and administration of CDAs MSAs MTAs Service Agreements Work Orders Change Orders and Amendments.
Work closely with all R&D business units to create real and active partnerships
Actively participate in CRO Governance reviews and meetings where applicable
Interact with retained CROs and other vendors on a regular basis to monitor their financial performance adherence to timelines to maintain CO logs and to manage invoice adjudication
Provide input into planning of clinical programs harnessing knowledge of supplier operational practices cost drivers timelines etc.
Identify new best practices and contribute to continuous improvement for site contracting
Participate in weekly Clinical Study meetings to provide updates on any financial aspects of vendor and site activities
Knowledge/Skills/Abilities Required
Minimum level of education and years of relevant work experience.
Bachelor’s degree in a finance or accounting discipline with 6 years of relevant clinical finance financial experience and biotech/pharmaceutical experience or relevant experience.
Special knowledge or skills needed and/or licenses or certificates required.
Solid clinical budget management experience in an operational environment.
Experience with financial management of Clinical Development vendors (CROs CTAs patient travel vendors etc.)
Business professional equipped with a unique combination of finance and clinical operations expertise with a proven track record of clinical finance management outsourcing and vendor oversight
Proactive datadriven results oriented individual with a strong sense of urgency and clear understanding of dependencies and business unit considerations.
Selfdriven professional with the ability to work independently and collaboratively as required in a fastpaced matrixed team environment consisting of internal and external team members.
Analytical thinker with excellent problemsolving skills with emphasis on process improvement and business relevancy and the ability to adapt to changing priorities and deadlines.
Detailed oriented analytical process manager with strong understanding of clinical development sourcing process.
Excellent negotiations skills
Proficiency with Excel PowerPoint and Microsoft Teams
Excellent interpersonal verbal and written communications skills.
Travel requirements
Up to 10%
EEO Statement
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals regardless of race color national origin gender age physical characteristics social origin disability religion family status pregnancy sexual orientation gender identity gender expression disability veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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