Contract, Clinical Outsourcing, Finance

Job Description Summary:

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 cross-functionally 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.
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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, start-up work orders, SOWs, change orders and amendments
• Coordinate vendor award and non-award 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, data-driven, results oriented individual with a strong sense of urgency and clear understanding of dependencies and business unit considerations.
• Self-driven professional with the ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving 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%

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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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