Manager, Site Contract Management

at  Precision Medicine Group

POSITION SUMMARY:

Work closely with Study Start Up, Clinical Operations, legal, HR, finance and other stakeholders to ensure Site Contracts team has all needed tools to deliver Site Contracts in the shortest possible time and play a key role to ensure all other deliverables of the Site Contracts group are in alignment with defined study timelines. This role will support to negotiations of contracts when needed and to deal with key clients. Will participate in corporate strategic initiatives for the Start Up group, such as Oncology Site Network and Rapid Start-up and will be part of the SSU Leadership.

QUALIFICATIONS:

Minimum Required:

• Bachelor´s degree or international equivalent experience ideally in a scientific or healthcare discipline
• Experience in Site Contracts departments in Clinical Research Organizations (CRO)
• Experience dealing with big health care institution in North America for performance/negotiations of clinical trials agreements.
• Experience in people management remotely.

Preferred:

• 8 years or more of relevant experience in drafting, reviewing, and negotiating Clinical Trial Agreements and site budgets, as well as line management experience, control and tracking of the contract process at the project and at portfolio level.
• Experience in setting up Site Contracting Plans and exposure to Sponsors.
• Experience in different models of site contract’s structure.

• Participate in the development process for update of work plans, process, policies, and procedures for overall site contract management in the organization at the regional level.
• Line manage part of the Site Contracts team by ensuring learning, development and alignment with Precision site contracting process, .
• Collaborate with resource team on projects needs and resource allocation.
• Participate in discussions on resources needs and plan site contract’s structure.
• report and manage contract metrics including productivity of the site contract’s function.
• Ensure adherence to company policies, procedures, and contracting standards.
• Partner with different stakeholders to resolve site contracts issues.
• Review, draft, and negotiate a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements, ancillary agreements, and amendment agreements.
• Oversee execution of agreements at the portfolio level according to each study contract plan
• Oversee the maintenance of contract files and databases, including contract archiving.
• Recognize where processes can be improved and take corrective action.
• Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
• Act as Subject Matter Expert in internal and external meetings including client meetings.
• Other tasks, as assigned.