Senior Study Manager - FSP

ATLAS MEDICAL SERVICES LTD. STI.; United States; Remote; USD 120,000 - 190,000; Full time

Benefits offered by this job

Flexible Work Program

Bravo Recognition Program

Well-being culture

Job summary

Parexel is seeking a Senior Study Manager - FSP in the United States with remote work options. You will oversee end-to-end clinical trial delivery, lead a cross-functional team, manage budgets and timelines, and ensure compliance with global regulations.

Travel approximately 10% to support trial activities and inspections. The role requires 7+ years of CRO/biotech/pharma experience managing global trials (Phase 1–4) and a BS/BA degree.

Qualifications

• BS/BA degree required.
• 7+ years of clinical research experience, CRO/biotech/pharma, end-to-end trial management (Phase 1–4).

Responsibilities

• Lead the cross-functional trial team to deliver the operational plan and end-to-end trial execution.
• Own trial delivery, budget, timelines, quality, and milestones; support planning and deviations.
• Oversee CRO/vendor identification, SOW setup, budget oversight and KPI tracking.
• Proactively ensure milestones are met and risks are mitigated.
• Ensure trial operations comply with global regulations and internal SOPs.
• Participate in Health Authority inspections and internal QA audits.
• Maintain inspection readiness and collaborate with R&D Quality for oversight.
• Mentor onboarding of new team members in Study Management.
• Interface with Finance, Program Management, Vendor Management, Safety, QA, Data Management, Statistics, Regulatory, Medical Affairs.
• Provide budget variance analysis and inform finance of cost variances.
• Support governance updates and presentations; travel ~10% as needed.

Skills

End-to-end trial delivery

Cross-functional leadership

Budget & forecasting

Risk management

Regulatory awareness

Vendor management

Education

BS/BA degree

Job description

Senior Study Manager - FSP

Primary Location: United States, Remote

Job ID: R0000047863

Category: Clinical Trials

About This Role

The Senior Study Manager is accountable for the end-to-end clinical trial delivery, providing operational leadership and oversight of cross-functional deliverables and leading a cross functional trial team to build and deliver the trial operational plan. This role is responsible for identifying and mitigating risks to effectively deliver assigned trials on time, within budget, and in a compliant manner.

Key Responsibilities

• Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL/ CSR/ TLR planning and scope, define protocol deviations and resolution pathways).
• Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
• Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
• Identify risks and ensure mitigations and contingencies are being initiated and followed through
• Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
• Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
• Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight
• Participate in process improvement activities at a trial and department level as needed
• Mentor & support onboarding of new team members, particularly those in Study Management.
• Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
• Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
• Support and provide input into internal governance presentations & updates
• Ability to travel approximately 10% but flexibility to go over or below as per business need).

Qualifications

• BS/ BA degree is required.
• Minimum 7+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company managing on Phase 1-4 global clinical trials end to end.

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Benefits & Support

• Benefits vary by country, but Parexel is passionate about our team’s overall wellness.
• At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture.

Career Advancement

• We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career.

Working where it works for you

• Parexel offers a flexible approach to work that meets your personal needs while maintaining quality delivery for patients. Choose the right work arrangement for you - in-office, home-based or a mix.

Our work culture

• Learn about our culture, perks, learning opportunities, and our corporate responsibility approach. Parexel's compassionate and results-driven work culture prioritizes patient care and employee growth.

Inclusion at Parexel

• Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment.

Parexel's hiring process

• It’s all about finding the right fit, for you and for us. Our recruiters work with you and our hiring managers to bring together a team and culture where everyone can grow and be successful.