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Associate Director, Clinical Contracts
at Clinipace Worldwide
Clinipace is a global full-service clinical research organization (CRO) serving the unique needs of venture-backed, mid-tier and strategic pharmaceutical, biotechnology and medical device firms. We help our customers advance drug candidates to deliver successful stakeholder and patient outcomes. We leverage extensive therapeutic knowledge, clinical trial expertise, and comprehensive innovative technology to support life science firms in achieving some of their most important goals: Executing regulatory strategies, optimizing clinical development timelines and completing high quality trials. We are proud to have a culture that is vibrant, supportive, performance-driven, and passionate while focusing on continual learning and development. Clinipace associates are passionate about their lives and bring that same passion to their work at Clinipace.
United States | North Carolina (Morrisville)
Job Title: Associate Director, Clinical Contracts
Job Location: United States (Home based, regional)
The Associate Director, Clinical Contracts will manage the Clinical Contracts(Legal) team to provide the leadership, support and guidance to successfully lead a global, company-wide Clinical Contracts team. This position requires an effective leader and communicator who is comfortable working cross-functionally within the corporate structure.
Job Duties and Responsibilities:
Includes all duties of a Associate Director, Clinical Contracts and may include duties of a Contracts Manager as needed to support the department, plus the following:
- Responsible for management of all global clinical contract agreements including, but not limited to, Clinical Trial Agreements (CTAs), investigator agreements, confidentiality agreements, ancillary agreements, pharmacy agreements, site master service agreements, consulting agreements, single-service, subcontractor agreements among other agreements in the clinical contract space.
- Work with teams to develop study specific plans and processes
- Oversees Clinical Contracts team, related processes and procedures, including revisions and process improvement initiatives as needed.
- Provides the supervision, direction and performance metrics for the Clinical Contracts team.
- Responsible for all aspects of document and metric tracking for all relevant agreements, including working in relevant systems.
- Ensures that agreements comply with legal, regulatory, and company requirements, regarding risk assessment and liability. This includes updating and creating templates as necessary.
- Responsible for ensuring that the negotiation process is maintained and improving to meet the financial and operational needs of both Clinipace and our clients.
- Responsible for identifying and maintaining a negotiation model that has a global approach and will meet the needs of the organization. The model will be fully capable of managing multiple currencies, foreign exchange and all operational budget needs.
- Represent Clinipace in proposal development, business development, kick-off meetings, and customer audits.
- Subject Matter Expert in contract negotiations and associated industry systems.
- Conduct direct negotiations on projects and sites as needed.
- Provide customer facing for full service opportunities and assist in leading any functional service provider opportunities.
- Strong knowledge of Study Start-up and able to provide support and supervision (if necessary).
- Other tasks and responsibilities as requested by departmental and company leadership.
Supervise and provide direction to team members in Clinipace regions, including the Americas, EMEA, and/or Asia Pacific
- BA/BS required in legal studies or related discipline. Advanced degree preferred.
- Ability to effectively develop new policies/procedures and processes: Manages the development of documented process(es) covering multiple functional areas and individuals. Development and implementation of new policies and procedures based on identified needs.
- Excels in contract and budget creation and negotiations: Demonstrated proficiency in the development and negotiation of contracts and budgets to achieve mutually beneficial results for internal and external parties.
- Create and develop effective contract templates and tools.
- Microsoft Office desktop applications.
- Able to work independently and efficiently.
- Able to travel occasionally as required.
- Able to work constructively in a team environment as a participant or team leader and to collaborate and build consensus with team members.
- Collaborative team-player, willing to help out with whatever is needed at any time.
- Ability to “roll up sleeves”, and contribute as requested by the leadership of the Clinipace legal department.
- Relationship building with positive results with both associates/peers and external customers/sponsors.
- Successfully proven management skills: Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and/or addresses issues. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate solutions; while looking for opportunities for improvements.
- Experience leading and facilitating team members and peers: Demonstrated leadership skills; successfully managed definition, implementation and ongoing assessment of new processes.
- Practices professionalism and integrity in all actions: Shows support for teamwork, cooperation, self-control, and flexibility to get work done regardless of efforts required.
- Able to work under pressure: Demonstrates an understanding of deadlines by meeting customer needs promptly, meeting committed time lines and assisting others in doing the same. Demonstrates ability to establish reasonable timelines.
- Superior organizational skills and attention to detail, including the ability to multi-task and re-prioritize multiple priorities on a daily basis, while maintaining demanding primary work schedule.
- Excellent written and oral communication skills and strong contract drafting and negotiation skills.
- Possesses win/win attitude: Demonstrates a positive and professional attitude when negotiating contracts. Able to listen and understand the other party’s concerns and develop win/win solutions that meet both party’s needs.
- Maintains extensive knowledge of global clinical contract negotiations: Understands the contract negotiations process. Knowledgeable about the critical elements for success in clinical trials. Demonstrates a high level of expertise in relationship management.
- Expertise to participate as an “internal” consultant for Clinipace with respect to clinical contract negotiations. Has successfully developed and administered process training and successfully supported others outside direct responsibility.
- 8+ years of CRO/Sponsor experience in contracts.
- 5+ years experience in line management, department management and fluid cross functional department interactions.
The company will not accept unsolicited resumes from third party vendors.