Site Selection Lead II
Labcorp Drug Development
hace 4 días

Job Overview :

LabCorp is seeking candidates for a Site Selection Lead II. The Site Selection Lead II can be remotely located anywhere within the Latin America Region

  • Develop, in conjunction with the Global Feasibility Lead, the initial site list for feasibility and site identification
  • Full oversight of the Feasibility / Site identification process : survey development and programming, local resource training and oversight, oversight of site outreach process, creation of progress reports, site selection tool and decision making, customer interaction
  • Collaborate with Global Feasibility Leads to support collection of country and investigator feedback in the pre-award space;
  • provide summary and analysis of results

  • Responsible for setup and conduct for feasibility / site identification studies according to timeline and quality standards and client expectations - learning to negotiate timelines or KPIs directly with customers
  • Develop site lists according to the program or protocol : Work closely with Global Feasibility Lead, strategy, and start up teams to understand optimal site profileEvaluate the available sources of potential site information, and the pros and cons of each.
  • Manage timelines and any changes to the target site list requirements up until the site is fully identified and the target number of potential sites in each defined region and country is achieved.

    Helping to facilitate identity matching by coordinating the triggers for master data management

  • Independently performs literature and internet searches as required.
  • Masters and fully exploits all available data sources for site performance.
  • Create electronic surveys using company software and produce any required standalone or topline surveys
  • Trains and mentors SSL1, and newer SSL2s as needed, on core feasibility processes for all core feasibility tasks required of that role
  • Participates in, contributes, and potentially leads process improvement or special projects
  • Contribute to (and learn to potentially lead) internal planning meetings, client interactions, and interim teleconferences.
  • Ensure accuracy and quality of survey driven data
  • Work with team to identify potential risks and out of scope activity; discusses contingency plans with stakeholders as appropriate.
  • Ensure site identification team in each country is entering and updating internal tracking tools.
  • Contribute to best practice for feasibility / site identification conduct.
  • Contribute and deliver training of feasibility and site identification requirements / processes
  • Liaise with the global, cross-functional teams, inclusive of legal, start-up, clinical, country teams, and project management.
  • Contribute to audit presentations / documentation based on site ID oversight
  • Performs any other duties as assigned
  • Education / Qualifications :

    Minimum Required :

  • Qualified candidate has an Associate’s degree with equivalent work experience or equivalent years relevant work experience
  • Minimum of 4 years of full-time working experience, with minimum 2 year in the drug development or healthcare industry, working in some capacity with data related to investigators and / or clinical research institutions.
  • Other required work-related experiences : Knowledge of ICH / GCP guidelines.
  • Experience in protocol or site feasibility related to clinical research, in platforms used for protocol feasibility, site identification / selection with web based surveys and with master data management a plus.
  • Position-specific Requirements :

  • Strong understanding of the feasibility, site identification, and selection for clinical trials
  • Clinical, start up, project management, or regulatory experience helpful
  • Familiarity and understanding of investigator performance data
  • Strong writing and presentation skills
  • Upholds the highest standard of personal professionalism and work integrity
  • Demonstrated ability to work independently
  • Strong attention to detail / quality control skills
  • Ability to establish and maintain effective working relationships with team members, management, operations staff, clients, and executive management
  • Demonstrated ability to handle multiple competing priorities effectively
  • Negotiation and relationship management skills
  • Experience in analysing study and investigator performance metrics
  • Self-motivated, works effectively under pressure
  • Technical Requirements :

  • Strong computer skills, including strong working knowledge of Microsoft Office, Excel and other data capture and compilation tools
  • Experience with data manipulation, analysis, reporting and maintenance
  • Experience with investigator performance databases and CTMS a plus
  • Proven written and verbal communication skills
  • Experience :

  • Qualified candidate has an Associate’s degree with equivalent work experience or equivalent years relevant work experience
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