Investigator Svcs Analyst 2_PL

Investigator Services Analyst

ABOUT THE ROLE

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.

Responsibilities:

Contract & Budget Negotiation

• Negotiate clinical trial contracts and investigator site budgets between sponsors and clinical sites, primarily in the US, with a smaller number of non-US sites.

• Work with sponsor-provided contract templates and approved fallback language and budget positions.

• Conduct negotiations on behalf of sponsors and manage the process independently, with sponsor guidance.

• Escalate unresolved contractual or budget issues to sponsors when necessary.

• Coordinate the contract signature process using DocuSign.

• Develop/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/applicable to the position. 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.

• Ability to develop and suggest alternate contracting language, terms, and financial options.

Operational Support & Systems Management

• Update and maintain internal platforms and repositories, including:

  • Negotiated contract and budget versions.

  • Document status and records.

  • Information required for client reporting.

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

• 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.

Stakeholder Collaboration & Meetings

• Attend client and study team meetings, with frequency depending on study requirements (weekly, biweekly, or monthly).

• 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.

• Deliver presentations to clients as required.

• May take a proactive role in developing long-standing relationships with preferred IQVIA clients/customers.

Quality, Strategy & Leadership

• 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.

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

• 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.
  
   

Must- have:

• Education & Experience:

  • Bachelor's Degree in a related field required.

  • 5 years of relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable global and/or regional experience acting as a contract negotiator (or equivalent combination of education, training, and experience).

• Domain Expertise:

  • Previous experience in investigator grant budget and contract negotiations.

  • Experience with both US and non-US sites, with strong knowledge of US contracting and budget processes being particularly important.

  • Understanding of contract negotiations, including fallback language, budget costs, and sponsor-approved positions.

  • Experience in the pharmaceutical industry, a CRO, biotech, or an organisation supporting global clinical research.

  • Understanding of clinical trials, the clinical study start-up process, regulated clinical trial environment, and drug development process.

  • Knowledge and ability to apply GCP/ICH, applicable regulatory guidelines, regulatory requirements, SOPs, and company's Corporate Standards.

Key skills:

• Ability to manage negotiations independently and escalate issues appropriately.

• Strong time management skills to meet contractual turnaround times and avoid delays to SIV dates, IRB/ethics submissions, and regulatory submissions.

• Attention to detail, particularly when reviewing and finalising contractual terms, budgets, and documents for execution.

• Understanding of contractual and legal terminology, budget terms, and medical terminology. Strong legal, financial, and/or technical writing skills.

• Ability to maintain accurate documentation and represent IQVIA professionally in meetings with sponsors and clinical teams.

• Good negotiating and communication skills with ability to challenge; good interpersonal skills and a strong team player.

• Ability to exercise independent judgment, taking calculated risks when making decisions; ability to lead, motivate, coach, and mentor.

• 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.

• Strong understanding of particular Sponsor or stakeholder needs and ability to share this knowledge effectively with others.