New · posted Nov 13
Parexel · Pharmaceuticals
Senior Study Manager - FSP
- Remote, US
- Remote
- Full-time
- Manager
What you need
- 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.
What you'll do
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.
- 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).
From the posting
About Parexel
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Equal opportunity, accessibility and legal noticesParexel's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 13, 2026
Salary intelligence
How the pay compares
Manager roles in the US46 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $140,750 | $161,250 | $169,500 |
Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, November 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 84 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not Parexel's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct5
- Collaboration and leadership5
- GMP and compliance3
- Regulatory submissions2
- Lab testing and methods1
- Documentation and SOPs1
- Investigations and CAPA1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Trial Management work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
Company hiring pulse
Parexel on Regulatory Jobs
- 54
- Open roles
- 54
- Distinct roles
- 6
- Locations
By discipline
- Clinical37 69%
- Regulatory16 30%
- Quality1 2%
By level
- Senior & Principal35 65%
- Manager11 20%
- Associate & Specialist6 11%
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Senior Study Manager - FSP at Parexel
Open until filled.