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 be part in preparation of KOM and BDMs, as well as the 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.
Essential functions of the job include but are not limited to:
• Review, update and/or establish process and procedures for overall site contract management in the organization at the regional or global level.
• Line manages a team of site contracts managers and contract and budget associates.
• Allocate resources for new business in the organization, forecasting and planning current and expected work.
• Participate in discussions on resources needs and plan for the future on site contract’s structure.
• Establish, track, report and manage contract metrics including productivity of the site contract’s function.
• Ensure adherence to company policies, procedures, and contracting standards.
• Escalate and resolve complex issues with legal, finance or supervisor.
• 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.
• Represent the organization as Subject Matter Expert in internal and external meetings including client meetings.
• Other tasks, as assigned.
Qualifications:
Minimum Required:
• 4-year college degree or equivalent experience ideally in a scientific or healthcare discipline
• Experience in Site Contracts departments in Clinical Research Organizations (CRO), Pharmaceutical companies or at Health care institutions linked to clinical trials.
• 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 management, control and tracking of the contract process at the project and at portfolio level.
• Experience interacting with health care organization globally.
• Experience in setting up new regions for site contracts group.
• Experience in different models of site contracts structure.
Skills:
Competencies:
• Possesses strong organizational and written communication skills with attention to detail.
• Able to multi-task and prioritize in a fast-paced environment.
• Able to make things happen.
• Executes time-sensitive matters while maintaining accuracy and attention to detail.
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Displays sound business judgment and a proactive, independent work style.
• Proficient in MS Office software programs and computer applications including site budget planning tools.
• Handles sensitive issues with discretion.
• Works well independently and cooperatively with others to achieve common goals in a virtual environment.
• Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
• Ability to drive and availability for domestic and international travel including overnight stays.