Site Contract Specialist
Oncology-focused Global Pharmaceutical company.
Under the guidance of the Manager, Site Contracts and Budgets, this position will drive tactical delivery of assigned studies or programs for the Global Clinical Study Support Department. The role will participate on project teams 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.
* Negotiate contractual documents using established negotiation and escalation plans.
* Track progress and status of contractual negotiations and prepare appropriate status reports as required.
* Facilitate execution of contractual documents between investigator, site, and Client.
* Serve as 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 creation, distribution, negotiation, and execution of contractual documents.
* Serve as primary point of contact and escalation for investigator sites, global negotiation network, or study team members during negotiation of contractual documents.
* Assist with preparation of performance metrics, such as median cycle times.
* Notify management, as appropriate, of any out-of-scope requests or activities, timeline changes, or resource constraints.
Requirements:
* B.A./B.S. preferably in business or science/health care field, nursing degree, or equivalent degree.
* Five years of prior experience in client service role at biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities.
* Prior Study Start-Up experience at biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities.
* Prior experience working with electronic document management system(s) or similar portal environment desired.