Site Identification Lead (homebased)

Icon plc - North Wales, PA (30+ days ago)3.6


"At ICON, it's our People that set us Apart"

ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 40 countries and has approximately 13k employees. Further information is available at www.iconplc.com

Site Identification Lead

Role Responsibility

  • To act as the main point of contact for the study on all aspects related to site identification
  • To lead the site identification 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 Identification 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 Identification Questionnaire specific to each protocol for discussion/approval with the project team/Sponsor.
  • Develop and implement site ranking plan based on above, to ensure the appropriate, high quality sites are approved for the study
  • Lead a team of Site Identification Specialists (SIS’s) who have responsibility for Site Identification.
  • 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.
  • Ensure appropriate tracking and status reporting on progress to the Sponsor/Project team
  • Ensure that any issues identified during the feasibility / Site Identification stage are handed over to the PM/CTM so that the CRA can follow up appropriately at PSV e.g. follow up regarding ECAC, Site Data protection form, due diligence issues for follow up etc.
  • Implement training and performance goals for the SIS team assigned to the study for site identification and ensure all tracking/documentation fully up to date in ICON’s 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 in order 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 identification or recruitment planning is of high quality, accurate and fully documented in ICON’s 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 ID services assigned to the candidate.
  • Act as a subject matter expert in relation to Site identification for internal/external clients, whether based on ICON SOPs or Strategic Business Processes for key clients
  • 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 Identification group, in order to improve quality and timelines taking into account 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 centres around our commitment to People, Clients and Performance.
  • To undertake other reasonably related duties as my be assigned from time to time
  • *Travel (approximately 15%) domestic and/or international.

Experience and Qualification

  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Have a background in medicine, science or other relevant discipline with substantial international experience in clinical drug development across a broad range of therapeutic areas
  • Good commercial awareness of current practices and trends Recruitment Planning across the industry
  • US/CAN/LATAM: At least 5 years industry experience with a minimum of 2 years’ experience in Site identification planning in addition to a minimum of 2 years’ experience across a broad range of therapeutic areas as a manager and / or project manager.
  • EU/APAC- Proven industry experience with some experience in Site identification planning in addition to a minimum of 2 years’ experience across a broad range of therapeutic areas as a manager and / or project manager.
  • Excellent communicator, both in written and spoken language. Able to produce reports and project plans to a high standard in addition to being able to review the quality and content of reports produced by the Recruitment planning Team. Fluent in English is essential
  • Well-developed negotiation skills with the ability to liaise successfully with senior management, clinical project teams, other ICON departments and clients. As well as to influence and present to both small and large groups.
  • Competent computer skills in MS Word, Excel and PowerPoint
  • Highly developed organizational, problem solving and analytical skill, with the ability to prioritize time-sensitive tasks and work independently, to make decision and to progress projects
  • Able to multi-task and work well within high pace pressurized environment

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

Job Type: Full-time

Experience:

  • Site Identification: 5 years (Preferred)

Education:

  • Bachelor's (Required)