Senior Study Manager - FSP

Parexel; Salem (OR); Remote; USD 120,000 - 190,000; Full time

Job summary

Parexel is seeking a Senior Study Manager to lead end-to-end clinical trial delivery, providing operational leadership across cross-functional teams and building the trial operational plan to deliver on time and within budget.

You will identify and mitigate risks, ensure compliance with global regulations, support inspections, and mentor staff while coordinating with finance, quality, and data management. Occasional travel up to 10% may be required.

Qualifications

• BS/BA degree required.
• Minimum 7+ years of clinical research experience in CRO/Biotech/Pharma managing global trials end to end.

Responsibilities

• Lead the 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; support planning and deviations.
• Oversee CRO/vendor identification, SOW creation, budget oversight and KPI tracking.
• Ensure trial deliverables and milestones meet corporate and study-level goals.
• Identify risks and implement mitigations and contingencies.
• Ensure trial operations comply with global regulations and internal procedures.
• Participate in Health Authority inspections and internal QA audits.
• Maintain inspection-readiness and quality oversight with R&D Quality.
• Engage in process improvements at trial and department levels.
• Mentor and onboard new study management staff.
• Interface with Finance, Program Management, Vendor Management, Safety, QA, DM, Statistics, Regulatory, Medical Affairs; may liaison between groups.
• Provide budget variance analysis and communicate projected cost overruns/underruns.
• Support internal governance presentations and updates.
• Travel approximately 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.