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Manager, Clinical Site Contracting

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Taipei, Taipei
Posted an hour ago
2 views

Job Description

The Manager, Clinical Site Contracting (MCSC) is responsible for ensuring that contracts required for Clinical Studies are executed in a compliant and timely manner. This position works both independently and in collaboration with other leaders, to implement the clinical contracting strategy and ensure the quality of contracts and budget produced. This includes Clinical Disclosure Agreements (CDAs), Clinical Study Agreements (CSAs), Master Clinical Study Agreements (MCSAs), Investigator Initiated Study (IIS) Agreements, and other contract types as applicable. Acts as Subject Matter Expert (SME) and leader for specific focus areas (e.g., US budgets, global implementation of best practice, system superuser etc.). The ability to manage internal and external relationships effectively and lead and develop a highly experience team are key success factors for this position. The MCSC will have direct line management / supervisory responsibility.

•Understands cost drivers associated with CSAs and associated contract types and drives negotiations that ensure fair market value, compliant agreements. Highly competent in negotiation, strategy, and contracting business standards.
•Demonstrates a high level of outsourcing and technical competencies across clinical study agreements and therapeutic/functional areas and plays a key role in making decisions through careful evaluation of benefit/risk.
•Communicate, liaise with, manage, and train colleagues and customers, including investigational sites, on the contracting process and the life cycle of a contract. Play a key role in the performance and maintenance of effective collaborations with internal and external stakeholders.
•Build, manage and develop staff, supporting the growth and development of up to 5 direct reports. Provide guidance and subject matter expertise to support, train, and mentor direct and indirect reports.

•Demonstrate excellent communication skills and effectively present key information to stakeholders. Plays a key role in working closely with TA/FA's, Legal, OEC and investigational sites to resolve contract issues.
•Demonstrate subject matter expert (SME) status and leadership to identify the need for and play a key role in cross functional process improvement initiatives. Drive continuous improvement in team performance and areas of subject matter expertise.
•Managing templates, works with legal to make sure they are updated from language and systems perspective.
•Development of SOPs and job aides, and the development of training tools associated with new processes.

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