Manage the contract strategy and support the delivery of all required start-up contracting activities for selected sponsors and for complex studies or multi-protocol programs as determined by the Sponsor’s requirements. May include line management responsibilities.
Essential Functions
- Responsible for developing complex investigator grant estimates, contracting strategies, coordinating investigator grants, and proposal text to support proposal development.
- Develop contract and budget templates, contracting systems, tools, processes, and training materials for selected sponsors and complex studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
- Ensure collaboration and communication with sponsors, stakeholders, and RSU regions and countries to successfully deliver the project scope in compliance with sponsor requirements and the RSU Management Plan.
- Provide legal, operational, and financial contracting support to study teams, especially regarding site agreements, to facilitate efficient business development and maintenance of complex clinical trials, ensuring compliance with regulatory requirements and local laws.
- Create, review, and publish core scientific, technical, and administrative documentation to support business development and study initiation and maintenance.
- Assess and review the contracting landscape, contributing to the collection, interpretation, analysis, and dissemination of contracting intelligence to support studies and the wider company.
- Ensure overall contracting efficiency and adherence to project timelines and financial goals related to site agreements.
- Report contracting performance metrics and out-of-scope activities as required.
- Work with Quality Management to ensure appropriate contract management and quality standards.
- Mentor and coach colleagues, including delivering training materials and providing technical guidance within and outside the project.
- Deliver presentations to clients and professional bodies as required.
- Ensure accurate maintenance of internal systems (e.g., CTMS), databases, tracking tools, timelines, and project plans.
- Develop long-standing relationships with preferred IQVIA clients/customers and serve as a liaison for non-specific projects for top clients/customers.
Qualifications
- Bachelor's Degree in a related field (Req)
- 4 to 7 years of relevant sponsor or CRO clinical site contracting experience, including acting as an international contract expert.
- Good negotiating and communication skills, with the ability to challenge.
- Thorough understanding of the regulated clinical trial environment and knowledge of the drug development process.
- Proven ability to exercise independent judgment and take calculated risks.
- Strong project leadership skills, with the ability to motivate, coach, and mentor.
- Strong knowledge of clinical trial contract management.
- Ability to work well within a matrix team environment.
- Ability to establish and maintain effective working relationships with colleagues, managers, and sponsors.
- Ability to utilize metrics and communicate them to study teams to establish timelines for deliverables.
- Proven ability to lead projects or initiatives and grow programs to impact across departments.
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