Site Contract Manager

IQVIA•Durham, NC

18d

About The Position

Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor’s requirements. This role involves developing investigator grants and estimates, contracting strategies, and proposal text. The Site Contract Manager will also develop contract language, payment language, and budget templates, and utilize and maintain contracting systems, tools, processes, and training materials. Collaboration with sponsors, stakeholders, and RSU regions and countries is essential for successful project delivery in compliance with sponsor requirements and/or the RSU Management Plan. The position provides specialist legal, operational, and financial contracting support to Study Teams to facilitate efficient business development and the initiation and maintenance of clinical trials, while ensuring compliance with regulatory requirements. Additionally, the role assists with the creation and/or review of core scientific, technical, and administrative documentation, contributes to the collection, interpretation, analysis, and dissemination of contracting intelligence, and ensures overall contracting efficiency and adherence to project timelines and financial goals. The Site Contract Manager will also work with Quality Management to ensure appropriate contract management and quality standards, mentor and coach colleagues, and deliver presentations to clients. Accurate completion and maintenance of internal systems (especially CTMS), databases, tracking tools, timelines, and project plans are required. The role may involve developing long-standing relationships with preferred IQVIA clients/customers.

Requirements

Bachelor's Degree Related field
2+ year relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable global and/ore regional experience acting as a contract negotiator.
Equivalent combination of education, training and experience.
Good negotiating and communication skills with ability to challenge.
Good interpersonal skills and a strong team player.
Strong legal, financial and/or technical writing skills.
Strong understanding of regulated clinical trial environment and knowledge of drug development process.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards.
Ability to exercise independent judgment, taking calculated risks when making decisions.
Ability to lead, motivate, coach and mentor.
Good organizational and planning skills.
Good presentation skills.
Strong knowledge of Microsoft Office and e-mail applications.
Good understanding of clinical trial contract management.
Ability to work well within a matrix team environment.
Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
Ability to develop and suggest alternate contracting language, terms, and financial options.
Strong understanding of particular Sponsor or stakeholder need and ability to share this knowledge effectively with others.
Ability to utilize metrics and then communicate these with study team to establish timelines for deliverables.

Responsibilities

Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs.
Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.
Develop contract language, payment language and budget templates as required.
Utilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
Assist with the creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
Contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence to support assigned studies and the wider company, as required.
Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreements.
Report contracting performance metrics and out of scope contracting activities as required.
Work with Quality Management to ensure appropriate contract management and quality standards.
Mentor and coach colleagues as required including the delivery of training materials as required.
Deliver presentations to clients as required.
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.
May take a proactive role in developing long standing relationships with preferred IQVIA clients/customers.