Senior Study Manager - FSP

Parexel; Helena (MT); Remote; USD 130,000 - 170,000; Full time

Job summary

Parexel is seeking a Senior Study Manager in the United States to lead end-to-end clinical trial delivery. You will oversee cross-functional teams, manage budgets, timelines, quality, and milestones while ensuring regulatory compliance and readiness for inspections.

The role includes mentoring new staff and collaborating with multiple internal stakeholders. Applicants should bring significant CRO/biotech/pharma experience across Phase 1–4 trials, with a focus on risk management and process

Qualifications

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

Responsibilities

• Lead cross-functional trial team to deliver the operational plan and end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality and milestones.
• Oversee CRO/vendor identification, set up, SOW creation, budget oversight and KPIs.
• Proactively ensure trial deliverables and milestones meet goals.
• Identify risks and implement mitigations and contingencies.
• Ensure trial operations comply with global regulations and internal SOPs.
• Participate in inspections and internal QA audits.
• Maintain an inspection-ready trial team with QA oversight.
• Contribute to process improvement at trial and department levels.
• Mentor and onboard new team members in Study Management.
• Interface with Finance, Program Management, Vendor Management, Safety, QA, Data Management, Regulatory and more.
• Provide budget variance analyses and notify finance of projections.
• Support and input into internal governance updates.
• Willingness to travel ~10% as needed.

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.