Senior Study Manager - FSP

Parexel; Montpelier (VT); On-site; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking an experienced Senior Study Manager to lead end-to-end clinical trial delivery from a cross-functional team. You will own the operational plan, manage risks, budgets, timelines, and quality, and coordinate CRO/vendor activities to ensure compliant, timely trials.

You will oversee cross-functional collaboration with Finance, Safety, Regulatory, Data Management, and QA, while guiding team members and maintaining inspection readiness across the organization.

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.

Responsibilities

• Lead the cross functional trial team to influence and execute delivery of the operational plan and end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones.
• Oversight of CRO/vendor identification, SOW creation, budget oversight and KPI tracking.
• Proactively ensure trial deliverables and milestones are met according to goals.
• Identify risks and ensure mitigations and contingencies are implemented.
• Ensure trial operations comply with global regulations and internal SOPs.
• Participate in Health Authority inspections and QA audits.
• Maintain trial team inspection-readiness and quality oversight with R&D Quality.
• Participate in process improvement at trial and department levels.
• Mentor and support onboarding of new study management members.
• Interface with key stakeholders across Finance, Program Management, Vendor Management, Safety, QA, Data Management, Clinical Research, Regulatory, and more.
• Provide variance analysis of budget to actual and alert finance to cost over/under expenditure.
• Support internal governance presentations and updates.
• Ability to travel approximately 10% with flexibility.

Skills

Clinical trial management

Budget oversight

Risk management

Vendor management

Quality assurance

Education

BS/BA degree

Job description

Summary of Key Responsibilities

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).

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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.

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EEO Disclaimer

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