Contracts And Bugets Negotiator

Job type:
Start date:
Real Staffing
Published at:
flag_no USA
Project ID:

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Contract Position
Location: Audubon, PA
Rate: $60/hour
This position is responsible for driving the tactical delivery of assigned sponsor/CRO studies or programs. This position will lead a project team to ensure various clinical study investigator initiation and maintenance services are accomplished on time, within budget, and in accordance with applicable financial, contractual, and pharmaceutical R&D industry standards and regulations. This position will be responsible for developing and negotiating site-specific CTAs, CDAs or other related contractual documents.
Qualifications & Experience:
B.A./B.S. preferably in a business or science/health care field, nursing degree, or equivalent degree and/or related experience
2+ years of study start-up experience in a clinical or regulatory operations capacity related to the distribution, collection, and management of essential regulatory documents and/or contracts preferred. Global experience strongly considered.
Prior experience at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities preferred
Prior experience in working with electronic document management system(s) or similar portal environment desired
Knowledge of the clinical trial process and ICH guidelines and FDA, IRB/IEC regulations/guidelines; experience with handling start-up documents with operational project teams and investigative sites
Occasional travel as needed