Investigator Site Contracts Manager, Biotech

Investigator Site Contracts Manager

Homebased

Job Overview
Manage the contract strategy and support 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. This is a sponsor facing role.

Essential Functions

• Responsible for the development of complex investigator grant estimates, contracting strategies, coordination of investigator grants, as applicable and proposal text to support the proposal development process.

• Develop contract and budget templates and 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, as applicable to the position.

• Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries, 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 complex clinical trials, whilst ensuring compliance with regulatory requirements and local laws.

• Create, publish and/or review core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.

• Assess and review the contracting landscape and 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, and provide technical guidance both within and outside the project.

• Deliver presentations to clients and professional bodies as required.

• As applicable, ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.

• Take a lead role in developing long standing relationships with preferred IQVIA clients/customers

• May serve as a liaison for non-specific projects for top clients/customers.

Qualifications and Skills

• Bachelor's or Law Degree

• 7 years' relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable experience acting as an international contract expert.

• Fluent in English

• Good negotiating and communication skills with ability to challenge.

• Legal background will be beneficial.

• Good interpersonal skills and a strong team player.

• Ability to coordinate and collaborate above, across and within complex projects.

• Excellent legal, financial and/or technical writing skills.

• Thorough 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.

• Proven ability to exercise independent judgment, taking calculated risks when making decisions.

• Strong project leadership skills, with ability to motivate, coach and mentor.

• Good organizational and planning skills.

• Good presentation skills.

• Strong knowledge of Microsoft Office and e-mail, Word and Excel applications.

• 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 co-workers, managers and sponsors.

• Ability to utilise metrics and then communicate these with study team to establish timelines for deliverables.

• Provide input into employee performance reviews, as required.

• Proven ability to take on a project or new initiative and grow the program to make an impact across departments.

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