Senior Study Manager - FSP

Parexel; Phoenix (AZ); Remote; USD 120,000 - 160,000; Full time

Job summary

Parexel is seeking a Senior Study Manager to lead end-to-end clinical trial delivery, providing operational leadership and cross-functional oversight to build and execute the trial operational plan. You will identify and mitigate risks to deliver trials on time, within budget, and in compliance, interfacing with multiple departments and CROs.

The role requires 7+ years in clinical research with CRO/biotech/pharma, overseeing global trials (Phases 1–4) and ensuring inspection readiness.

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 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).
• Oversee CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPIs 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 SOPs
• Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
• Ensure that the trial team operates in a 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; may include 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)

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.