Clinical Operations Manager - Early Phase Feasibility & Financial

Job Overview:

The Principal Strategy & Planning Specialist supports CPS clinical development strategy and external site partnerships by leveraging site capabilities, feasibility data, and key performance metrics. It collaborates closely with commercial and operational teams to provide strategic insights on site analytics, country-specific considerations, and multi-center planning. The position maintains the Strategy & Planning Study Resourcing and Site Library databases and contributes to business growth through data-driven feasibility analysis and study planning. Strong analytical, writing, presentation, database management, attention to detail, and stakeholder engagement skills are essential.

Summary of Responsibilities:

• Serve as a key member of the global strategy team, presenting compelling strategies that strengthen commercial efforts and drive growth.

• Collaborates closely with commercial and operational teams by delivering site analytics, feasibility intelligence, capability assessments, and country specific or multi‑specific or multi‑center strategy considerations.

• Conducts fair market value (FMV) reviews for proposals involving external site partners by leveraging an Excel-based costing tool to generate accurate FMV reference budgets.

• Generates standardized core budget templates using the Excel-based costing tool and GrantPlan to provide project teams with consistent, data driven baseline budgets that support effective site negotiations-driven baseline budgets that support effective site negotiations.

• Develops evidence based, data driven clinical trial strategies informed by expert insights and rigorous analytics. Deliver these strategies through white papers, executive summaries, proposals, bid defenses, feasibility assessments, competitive landscape analyses, and client facing presentations. ‑based, data‑driven clinical trial strategies informed by expert insights and rigorous analytics. Deliver these strategies through white papers, executive summaries, proposals, bid ‑facing presentations.

• Leverages data mining and research to identify trends in trial environments—such as country/site distribution, competition, and historical performance—to support strategic recommendations.

• Maintains and enhances the global external site partnership network and applicable Strategy & Planning Study Resourcing databases

• Assist in overall department goals and daily operations process efficiencies which may require the development of SOPs, job aids, work instructions, templates, checklists, trackers and forms, including controlled documents.

• The development of clinical trial strategies requires the development and management of external clinical investigator site partner relationships globally, requiring close collaboration across administrative, operational, and medical staff at external clinical sites. 

• Develop and build relationships with key investigation partners which may require governance, site success initiatives, site capability visits, site specific performance, issue escalation and resolution.

• Perform additional tasks as delegated by department manager

Qualifications (Minimum Required):

• Bachelor of Science or Science-related degree from a recognized University/College.

• Practical experience and understanding of global drug development and clinical trials including demonstrated experience in professional presentations.

• Working knowledge of Early Clinical Development

• Knowledge of the scientific principles, methods, and processes used to conduct a systematic and objective inquiry; including study design, collection, analysis, and interpretation of data; and the reporting of results.

• Strong data mining, analysis, and interpretation skills to support clinical trial strategies.

• Excellent technical/scientific writing and attention to detail.

• Critical thinking and problem-solving abilities.

• High level of professionalism, integrity, and global collaboration skills.

• Effective communication, planning, and organizational skills.

• Demonstrated ability to work independently with limited oversight

• Ability to manage multiple priorities and adapt to shifting expectations.

• Familiarity with ICH-GCP guidelines and global clinical trial processes, especially early-phase studies.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), SharePoint, and Adobe Acrobat.

• Skilled in using data capture, compilation, and analytics tools.

• Ability to understand and leverage various technology platforms.

Experience (Minimum Required):  

• Minimum of (5) years relevant experience in a pharmaceutical company/CRO including demonstrated skills across multiple competencies, i.e., Clinical Research Coordinator, Business Development, Project Management, Commercial, Strategy and Planning, Site Management.

• Experience in clinical proposal development, review, and site budget negotiations

  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Preferred Qualifications Include:

• Master’s degree or other advanced degree.

• Understanding of commercial clinical phase 1 unit operations, academic and hospital clinical research operations

• Knowledge of key therapeutic indications, drug and device development (i.e. metabolic, cardiology, CNS, inflammatory related disease areas).

• Knowledge of teaching, training, research, making presentations, lecturing, testing, and other instructional methods.

• Phase I clinical operations experience

  • Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.

Physical Demands / Work Environment:

Work Environment:

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

• Occasional travel to site locations both domestic and international, up to 10% of the time.

Physical Requirements:

• Frequently stationery 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.

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