Senior Specialist (CDSO) – FSP; US Remote Based

Fortrea•Durham, CA

14d•Remote

About The Position

Fortrea is currently seeking a US remote based Sr Specialist, Clinical Data Strategy & Operations (CDSO) – FSP to drive and support process development, evaluation, and implementations projects that are led by the CDSO Process Excellence and Delivery team or co-led with the Global Development Compliance Function. This is an (exempt) full-time, home-based position in the USA that will require willingness to work flexible hours as needed to meet business needs. WHAT YOU WILL DO In this role, you may independently lead projects or may provide support to the CDSO Process Excellence and Delivery team members as needed. As a Senior Specialist you may provide project management within the CDSO Process Excellence and Delivery team. Summary of Responsibilities: Lead process development, evaluation, and implementation activities or projects, in conjunction with CDSO Process Excellence and Global Development Compliance, for any of the following functions: Clinical Data Operations & Standards, Medical Writing, Testing, Innovation & Data Enablement, and Development Systems & Digital Strategy. Drive process activities by developing comprehensive project plans, timelines, and communication strategies, ensuring alignment across diverse stakeholders and SMEs. Lead and support new process and technology implementation across studies, collaborating with study team members and the CDSO Process Excellence team. Identify potential process documentation gaps and collaborate with the CDSO Process Excellence and Delivery team and other functions to propose and implement mitigations. Lead or support CDSO Process Excellence and Delivery team’s participation in inspection and audit readiness activities. Lead or support process activities associated with transfer of clinical trial execution activities due to acquisitions and mergers, working with various stakeholders to ensure compliance to processes. Provide project management support within the CDSO Process Excellence and Delivery team to assist in managing work allocation, project status reporting, team communications, and meeting management. Foster strong working relationships with cross-functional SMEs and stakeholders to align on strategic objectives, gather expert input, and drive decision-making in a matrix environment. Support CDSO Business Process Owners (BPOs) by coordinating initiatives, tracking deliverables, and facilitating stakeholder engagement across functional teams. And all other duties as assigned.

Requirements

Bachelor's Degree or international equivalent required; Life Sciences preferred.
8 or more years’ experience in the pharmaceutical industry or clinical research organization, including clinical data management/clinical trial data delivery & study reporting.
8 or more years of operational experience in project management, process improvement, clinical data management/EDC build and programming, IRT/eCOA implementation and management, data transfers/ingestion, centralized monitoring, and/or regulatory submission experience.
Understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, data management plans, clinical study reports) and processes.
Understanding of clinical trial technologies, including EDC, IRT, eCOA, digital wearable tools, CTMS, TMF systems, centralized monitoring systems, and clinical study report generation tools.
Excellent teamwork, organizational, interpersonal communication, active listening, conflict resolution and ability to influence without authority across various levels of organization.
Demonstrated matrix leadership and communication skills.
Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.
Global/international experience preferred, including the demonstrated ability to collaborate effectively with team members in other geographic locations.

Nice To Haves

Preferred experience in audit and inspection preparation and conduct for clinical data management activities.
Preferred experience in managing transfer of clinical data management activities from acquisitions and mergers, including effective collaboration with internal teams and external partners.

Responsibilities

Lead process development, evaluation, and implementation activities or projects, in conjunction with CDSO Process Excellence and Global Development Compliance, for any of the following functions: Clinical Data Operations & Standards, Medical Writing, Testing, Innovation & Data Enablement, and Development Systems & Digital Strategy.
Drive process activities by developing comprehensive project plans, timelines, and communication strategies, ensuring alignment across diverse stakeholders and SMEs.
Lead and support new process and technology implementation across studies, collaborating with study team members and the CDSO Process Excellence team.
Identify potential process documentation gaps and collaborate with the CDSO Process Excellence and Delivery team and other functions to propose and implement mitigations.
Lead or support CDSO Process Excellence and Delivery team’s participation in inspection and audit readiness activities.
Lead or support process activities associated with transfer of clinical trial execution activities due to acquisitions and mergers, working with various stakeholders to ensure compliance to processes.
Provide project management support within the CDSO Process Excellence and Delivery team to assist in managing work allocation, project status reporting, team communications, and meeting management.
Foster strong working relationships with cross-functional SMEs and stakeholders to align on strategic objectives, gather expert input, and drive decision-making in a matrix environment.
Support CDSO Business Process Owners (BPOs) by coordinating initiatives, tracking deliverables, and facilitating stakeholder engagement across functional teams.
And all other duties as assigned.