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For Companies At a Glance
- Tasks: Lead and support innovative clinical data projects in a dynamic remote environment.
- Company: Fortrea, a forward-thinking company in the pharmaceutical industry.
- Benefits: Competitive salary, comprehensive health benefits, and flexible time off.
- Why this job: Make a real impact in clinical data strategy while working from home.
- Qualifications: 8+ years in clinical research or project management; Life Sciences degree preferred.
- Other info: Join a collaborative team with global reach and excellent career growth opportunities.
The predicted salary is between 128000 - 136000 £ per year.
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.
Qualifications (Minimum 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.
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 $160,000-170,000
Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or 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.
Senior Specialist in Durham employer: Fortrea
Contact Detail:
Fortrea Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Specialist in Durham
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend virtual events, and engage on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Senior Specialist role.
✨Tip Number 2
Prepare for interviews by researching Fortrea and understanding their values and projects. We recommend practising common interview questions and tailoring your answers to highlight your experience in clinical data management and project leadership.
✨Tip Number 3
Showcase your skills! Create a portfolio or a presentation that outlines your past projects and successes in process development and implementation. This will give you an edge and demonstrate your hands-on experience to potential employers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Senior Specialist in Durham
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Specialist role. Highlight your relevant experience in clinical data management and project management, and show us how you can drive process development and implementation.
Showcase Your Skills: We want to see your skills in action! Use specific examples from your past work to demonstrate your expertise in clinical trial processes, project management, and collaboration with cross-functional teams. This will help us understand how you can contribute to our team.
Be Clear and Concise: Keep your application clear and to the point. Avoid jargon and make sure your key achievements stand out. We appreciate straightforward communication, so let’s keep it simple and effective!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Fortrea
✨Know Your Stuff
Make sure you have a solid understanding of clinical data management and the specific processes mentioned in the job description. Brush up on your knowledge of EDC, IRT, and eCOA technologies, as well as FDA and ICH-GCP guidelines. This will help you answer questions confidently and show that you're the right fit for the role.
✨Showcase Your Project Management Skills
Prepare to discuss your experience in project management, especially in relation to process development and implementation. Have examples ready that demonstrate how you've successfully led projects or supported teams in achieving their goals. Highlight your ability to create comprehensive project plans and timelines.
✨Emphasise Collaboration
Since this role involves working with cross-functional teams, be ready to talk about your teamwork and communication skills. Share specific instances where you've fostered strong relationships with stakeholders or navigated complex team dynamics to achieve a common objective.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities and how you handle challenges in clinical data operations. Think of situations where you've identified process gaps or managed compliance during audits, and be prepared to explain your thought process and actions taken.
