Fortrea · 11 hours ago
Senior Specialist (CDSO) – FSP; US Remote Based
United States
Full-time
Remote
Senior Level, Lead/Staff
$160K/yr - $170K/yr
8+ years expFortrea is currently seeking a Senior Specialist in Clinical Data Strategy & Operations to drive and support process development and implementation projects. The role involves leading projects, developing project plans, and collaborating with various stakeholders to ensure compliance and efficiency in clinical data operations.
Clinical TrialsHealth Care
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
Qualification
Required
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
Preferred
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
Global/international experience preferred, including the demonstrated ability to collaborate effectively with team members in other geographic locations
Benefits
Medical
Dental
Vision
Life
STD/LTD
401(K)
Flexible time off (FTO)
Company
Fortrea
Fortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions.
10001+ employees
H1B Sponsorship
Fortrea has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (25)
2023 (6)
Funding
Current Stage
Late StageLeadership Team
Anshul Thakral
Chief Executive Officer
Agnieszka Gallagher
General Counsel, Chief Compliance Officer and Corporate Secretary
Recent News
2026-01-06
Business Wire
2025-12-11
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