IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Clinical FSP Business

IQVIA clinical FSP business is unique.  Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our clients.  We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study.

Leadership recognises the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows.   Our managers understand the sponsors priorities and the individual aspects of each model.  Focus is given to career development from day one, including new hire orientation and onboarding, day to day problem solving and training and development.

Unique to the FSP model, our team contributes to the pipelines of the specific sponsor and therefore our team members are ‘indication and molecule experts’.  Additionally, IQVIA’s FSP business works with the Sponsors SOP’s, creating more continuity for both parties.

Currently we are looking for Global feasibility Specialist

Responsibilities:

1. In partnership and alignment with internal stakeholders gathers/leverages knowledge and insights to support indication, project, trial (and/or country) level feasibilities.

a. Epidemiological data detailing disease maps

b. Determination of clinical trial landscape

c. Recruitment assessment (e.g. potential challenges)

d. Summary of global/regional enrolment rates

e. Availability of active comparators

f. Disease insights

g. External Expert List

2. Develop comprehensive Feasibility Reports for presentation and discussion with internal stakeholders at project/indication and trial level to include;

a. Data-driven analysis and recommendations on potential country lists

b. Identify potential opportunities/challenges to mitigate operational risk

This will allow Clinical Trial Protocols to effectively fulfill requirements of the Clinical Development Plan while considering patient needs, and specific requirements/conditions of participating countries.

3. Prepare trial enrollment modeling scenarios at key milestones to provide data driven insight into recruitment strategies.

a. Prepare initial enrollment modeling scenarios as part of the strategic feasibility presentation to demonstrate overall expected site and timeline requirements

b. Update/modify enrollment modeling scenarios during the allocation process to reflect specific country feasibility feedback

c. Continue to refine/adjust enrollment modeling scenarios at the request of the team in order to evaluate the impact of significant budget, trial design and/or sample size changes.

4. Establish strategic site lists at the trial and/or indication level

a. Extract, synthesize, and de-duplicate site data and performance metrics from relevant resources (TriNetX, DQS, Citeline, CTMS, external vendors, etc) in order to provide teams with meaningful targeted site lists

5. Provide country feasibility support and facilitate country allocation

a. Recommend countries for participation in country feasibility based on the strategic feasibility results and identify key questions to be included in the country feasibility outreach

b. Provide trial enrollment modeling scenarios to optimize country allocation decisions in coordination with internal stakeholders (i.e. TMM, CTL, TACO)

Job Expertise:

Experience managing/conducting global and local/regional clinical trial feasibilities is preferred.

•Experience leading/managing clinical trials is an asset.

•Advanced understanding of sponsor criteria to qualify sites and staff to perform clinical human trials Phases I-IV.  

•Understanding of Clinical Development Process and clinical trials

•Understanding of GCP/FDA/ICH and legal/regulatory environment.

Job Profile:

Experience in clinical research and/or drug development required.

•Advanced understanding of sponsor criteria necessary to qualify sites and staff to perform clinical human trials Phases I-IV is required.

•Possesses a high degree of initiative, accountability and ability to balance multiple priorities with guidance.

•Demonstrated project management/influencing skills.

•Demonstrated GCP/FDA/ICH knowledge and legal understanding.

•Strong teamwork, negotiation and collaboration abilities.

•Strong influencing and oral/written communication skills.

•Ability to build relationships with mid/senior executive levels.

•Strong analytical/critical thinking skills.

•Proactive assessment of potential issues/business risk and development of risk mitigation plans.

•Good judgment regarding the “how”, “what” and “when” to address issues with leaders and key stakeholders.

•Demonstration of Accountability, Agility & Intrapreneurship (AAI) competencies and leadership of teams to deliver on AAI competencies.

•Ability to travel overnight domestically and/or internationally, as needed

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.