FSP Site Contract Specialist

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Under the guidance of the Site Contracts and Budgets Manager, this position will be responsible for driving the tactical delivery of assigned studies or programs for the Global Clinical Study Support Department. They will participate on a project team to deliver contract and budget negotiations on time and in accordance with applicable financial, contractual, and pharmaceutical R&D industry standards and regulations.  

Duties and Responsibilities

• Develop site-specific Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), or other related contractual documents (collectively, the “contractual documents”)
• Negotiate contractual documents using the established negotiation and escalation plan
• Track the progress and status of contractual negotiations and prepare appropriate status reports as required
• Facilitate the execution of contractual documents between the investigator, site, and sponsor.
• Serve as a mentor to new or junior staff, providing required project specific training and addressing project questions/issues
• Work collaboratively with study team to set up and maintain contract management systems that facilitate the creation, distribution, negotiation, and execution of contractual documents
• Serve as the primary point of contact and escalation for investigator sites, the global negotiation network, or study team members (e.g. CRAs) during the negotiation of the contractual documents
• Assist with preparation of performance metrics (i.e. median cycle times)
• Notify management, as appropriate, of any out-of-scope requests or activities, timeline changes, or resource constraints
• Other duties as assigned

 Requirements:

• B.A./B.S. preferably in a business or science/health care field, nursing degree, or equivalent degree
• Five (5) years of prior experience in a client service role at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities
• Prior Study Start-Up experience at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities
• Prior experience in working with electronic document management system(s) or similar portal environment desired

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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***