Senior Specialist (CDSO) – FSP US Remote Based

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 teams 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.

Qualifications (Minimum Required):

• Bachelors 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.

Experience (Minimum Required):

• 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.

• 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.

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists.

• Occasional crouching stooping with frequent bending and twisting of upper body and neck.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required.

Pay Range: USD $00

Benefits:All job offers will bebased on a candidates skills and prior relevant experience applicabledegrees/certificationsas well as internal equity and market data.Regularfull-timeor part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical Dental Vision Life STD/LTD 401(K) Flexible time off (FTO).

Application Deadline: 02/06/26

Learn more about our EEO & Accommodations request here.