Site Selection Lead I - FSP

Fortrea•Durham, NC

17h•Hybrid

About The Position

The Site Identification & Selection Associate will oversee and ensure the successful delivery of global (end-to-end) site identification and selection (strategy, plans, activities, timelines, synthesis of site/investigator insights and presentation to study teams) at a program/study level in collaboration with the Feasibility Director/Lead. Enable study teams to conduct effective and ongoing delivery within timelines that contribute to operational planning / decisions resulting in predictable delivery for achieving R&D goals. The Site Identification (ID) & Selection Associate, under the direction and guidance of the Feasibility Director/Lead, is responsible for site and investigator identification. Assists in the evaluation of sites and investigators to make selection decisions based on a data-driven study strategy and details about the site and investigator. Oversees the analysis of clinical trial intelligence data and its application to effectively identify sites in selected countries which complement study startup forecasts and study strategies. Create and implement innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued site identification and selection processes.

Requirements

BS degree or international equivalent required, in a life science preferred.
At least 2 years of pharmaceutical industry (or similar) experience.
Direct responsibility in site identification, feasibility, and/or managing the study start-up processes of clinical research studies at a sponsor or CRO is preferred.
Expertise with leading edge trial optimization vendors, tools, and methods.
Proficiency with software models, database structures, and Microsoft Office Suite applications.
Expertise in principles driving country/site identification desired.
Direct experience in the pharmaceutical industry or related field required.
Ability to strongly demonstrate, interpret, explain, represent, present and drive unbiased data insights into clinical trials operational planning.
Ability to work across several projects with specific and unique requirements, while providing attention to detail and high-quality work.
Ability to be flexible, adapt to change, work independently, as well as work as part of a team in a matrix environment.

Nice To Haves

Comprehensive understanding of the pharmaceutical industry and deep expertise in clinical drug development
Demonstrated experience in clinical operations and managing site identification and site feasibility processes
Demonstrated knowledge of government/international databases, open source databases or proprietary databases (e.g. PubMed/Medline, ClinicalTrials.gov, Citeline, DQS)
Demonstrated ability to form strong working relationships with other groups within the organization essential to high level performance in this position
Knowledge or FDA and ICH-GCP guidelines for conducting clinical research
Demonstrated ability to work across functions, regions and cultures
Enterprise level leadership with the ability to inspire, motivate and drive results
Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
Proven skills as an effective team player who can engender credibility and confidence within and outside the company
Ability to distil complex issues and ideas down to simple comprehensible terms
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
Ability to effectively implement R&D’s partnership strategy
Ability to build strong partnerships and drive role clarity with other interfacing functions.
Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
Comfortable challenging the status quo and bringing forward innovative solutions
Ability to take risks implementing innovative solutions, accelerating time to market
Ability to work in a global ecosystem (internal and external) with a high degree of complexity
Breadth of knowledge required across therapeutic areas, indications, and/or modalities.

Responsibilities

In coordination with the Feasibility Director/Lead, is accountable for defining, developing, and delivery of global site recommendations for each assigned study.
Ability to understand and translate protocol requirements to develop the ideal site profile, in collaboration with key cross-functional leads, especially the Feasibility Lead/Director.
Mine relevant databases, available literature resources, etc. to identify the best suited sites for the study and proactively advocate for inclusion of strategic relationship sites with the project team, as appropriate.
Assist in the development of the Site Profile and Protocol Specific Site Requirements and Site Identification Questionnaire/ Feasibility Survey specific to each protocol.
Provides tracking and weekly reporting of site identification deliverables to the study team and CRO.
Attends project team meetings (OSR, SET, Feasibility, Regulatory, etc.) provides updates relevant to site ID and selection.
Collaborates with Feasibility Lead/Director and Study Start-up team members in relation to the site identification and selection strategy.
Drive delivery of selected sites to ensure study milestones of First Site Active and First Subject In can be met.
Supports Feasibility Lead/Director in final selection of sites in collaboration with other Study Team members and CRO study representatives.
Ensure sites are notified of selection decision based on results of site level feasibility assessment.
May support the development and maintenance of the global investigator database and communication materials.