Investigator Services Analyst

eTeam; Polska; In loco; PLN 352.000 - 469.000; Tempo pieno

Descrizione del lavoro

eTeam is seeking a contract specialist to develop global contracting strategies and support start-up contracting activities for selected sponsors and studies. The role involves negotiating clinical trial contracts and site budgets, coordinating with sponsors, and maintaining internal systems (CTMS) to ensure efficient study initiation and compliance.

The candidate will manage negotiations, prepare budget language, and support proposal development across multiple time zones, with a 12-month

Competenze

• Bachelor's degree in a related field is required.
• 5 years of sponsor or CRO contracting experience.
• Experience with US and non-US sites and contracting processes.
• Familiarity with GCP/ICH and regulatory guidelines.

Mansioni

• Negotiate clinical trial contracts and investigator site budgets between sponsors and clinical sites, primarily in the US.
• Coordinate contract templates, fallback language, and budgets.
• Manage contract negotiations independently with sponsor guidance.
• Escalate unresolved issues to sponsors as needed.
• Coordinate contract signature process using DocuSign.
• Develop/coordinate investigator grants, budgets, and text for proposals.
• Maintain contracting systems, tools, and training materials per project plan.
• Mentor colleagues and support training on contracting practices.

Conoscenze

Negotiation

Time management

Attention to detail

Contract terminology

Written communication

Interpersonal skills

Team leadership

Microsoft Office

CTMS

Formazione

Bachelor's Degree in a related field

Strumenti

DocuSign

CTMS

Descrizione del lavoro

Client: a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry.

About the Role

• Contract: 12 months fix term contract with possible extension
• Working hours: 40 hours per week. Standard working hours of 9:00 AM-5:00 PM are expected to provide sufficient overlap with US mornings and scheduled team meetings. Candidate must be flexible to accommodate occasional meetings across time zones.

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

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.
• 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.

Qualifications

ABOUT THE CANDIDATE

• 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).
• 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.

Required Skills

• Ability to manage negotiations independently and escape 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