Site Selection Lead

The Site Selection lead will provide functional leadership for the Site Selection process based on the approved country and site strategy. The Site Selection Lead will liaise with PM, CTM, and Sponsors to ensure delivery of the Last Site Selected Milestone.

Responsibilities:             

• To act as the main point of contact for the study on all aspects related to site selection.

• To lead the site selection process for awarded studies, liaising with the assigned feasibility manager from a country feasibility point of view.

• Attend Kick off meetings for projects to ensure full awareness of client needs.

• Review Site Selection budget and propose changes as required for study delivery to the PM.

• To liaise with the Study Start up manager/Lead to ensure an integrated start up plan to ensure delivery of the study start up timelines in terms of initiated sites and First Patient In (FPI) milestones.

• Develop Site Profile and Protocol Specific Site Requirements and Site Selection Questionnaire specific to each protocol for discussion/approval with the project team/Sponsor and ensuring the sites are meeting those criteria.

• Develop and implement site-ranking plan based on above to ensure the appropriate high-quality sites are approved for the study.

• Lead a team who have responsibility for Site Outreach.

• Ensure debarred, previously poor performing Investigators are not included in Site identification process (or country feasibility if appropriate) and ensure relevant parties, such as Feasibility Manager and Project Manager are aware of any Audit or Regulatory findings that may influence reasons for site selection. This is to be documented by means of a due diligence report.

• Ensure appropriate follow through with sites on any inconsistencies in data provided for analysis and to chase outstanding data to ensure a complete data set. follow through with sites on any inconsistencies in data provided for analysis and to chase outstanding data to ensure a complete data set.

• Ensure appropriate tracking and status reporting on progress to the Sponsor/Project team.

• Ensure that any issues identified during the feasibility stage are resolved prior to the selection of the site e.g. follow up regarding COI, Site Data protection form, due diligence issues for follow up etc.

• Implement training and performance goals for the team assigned to the study for site selection and ensure all tracking/documentation fully up to date in relevant systems.

• Develop proposed site and country scenarios/plans and proposed recruitment rates, as well as any other recommendations, for approval by the Sponsor/Project teams to come up with final scenario plan for the study, working with the Feasibility manager, as needed.

• Ensure that all data collected in the support of feasibility, site selection or recruitment planning is of high quality, accurate and fully documented in relevant systems.

• Preparation for, and attend, client meetings as required, to ensure that the services of the group are clearly presented and used to support strategic project planning.

• To be accountable for delivery on time, on budget and managing the hours of all staff associated with site selection services assigned to the candidate.

• Provide strategic input to Business Development, Operations and to Sponsors and to be an expert resource to teams.

• Provide input on process improvement for the Site Selection group, to improve quality and timelines considering lessons learnt from ongoing projects. lessons learnt from ongoing projects.

• Deliver high quality standards and strive for excellence, act in a proactive, flexible, and responsive manner to both internal and external customer needs.

• Recognize, exemplify, and adhere to ICON's values which centers around our commitment to People, Clients and Performance.

• To undertake other reasonably related duties as may be assigned from time to time.

• Travel (approximately 15%) domestic and/or international.

• To embrace and contribute to our culture of process improvement with a focus on accelerating concept to cure.

• Responsible for creating and managing the project-specific Site Selection strategy.

What you need:

• Bachelor's Degree

• 3-6 years of experience in a Clinical Research environment, focusing on Start Up experience

• Project management skill set

• Understanding of site selection processes in many different countries

• Excellent written and verbal communication

• Ability to work to tight deadlines

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