Job Title: Senior Manager Clinical ComplianceJob Description
The Senior Manager Clinical Compliance leads global inspection readiness and clinical quality initiatives across clinical development programs. This role oversees Trial Master File (TMF) inspection readiness, drives corrective and preventive action (CAPA) and continuous improvement activities, and partners closely with cross-functional teams and external vendors to maintain a robust GCP-compliant quality framework. The position offers the opportunity to spearhead clinical compliance for a growing biotechnology organization, support an exciting pipeline across multiple clinical trial phases, and work directly with executive leadership in a long-term, strategic capacity.
Responsibilities
- Lead inspection readiness activities across global clinical development programs, ensuring studies and programs remain in a constant state of readiness for regulatory inspections.
- Develop, implement, and maintain study-level and program-level inspection readiness plans aligned with GCP and regulatory expectations.
- Coordinate cross-functional inspection readiness meetings and governance activities to align stakeholders and track progress.
- Conduct gap assessments and risk evaluations to assess inspection readiness and identify areas requiring remediation.
- Monitor inspection readiness metrics, trends, and key performance indicators, and recommend process and system improvements.
- Promote and embed a culture of continuous inspection readiness across all clinical functions.
- Review sponsor and regulatory audit findings and ensure there is a robust site plan to address observations.
- Facilitate root cause analysis and develop effective CAPAs following audits and inspections.
- Monitor CAPA implementation, verify effectiveness, and ensure timely closure of actions.
- Identify opportunities for continuous process improvement and support Operational Excellence initiatives that strengthen quality systems and inspection readiness.
- Oversee the TMF team to ensure Trial Master Files are inspection-ready at all times.
- Perform TMF health checks and lead or support remediation activities when gaps are identified.
- Monitor TMF quality, completeness, and timeliness to ensure documentation meets regulatory and internal standards.
- Ensure TMF practices comply with the TMF Reference Model and ALCOA+ principles.
- Support implementation of GCP quality initiatives and inspection readiness strategies across clinical development.
- Perform compliance assessments to identify areas of regulatory and quality risk within clinical programs.
- Monitor quality metrics, inspection trends, and compliance indicators to inform risk-based quality management.
- Support internal audits and inspection readiness assessments, partnering with Quality Assurance and other stakeholders.
- Collaborate with CROs and strategic vendors to ensure their processes and deliverables support inspection readiness.
- Review vendor quality metrics and inspection readiness activities, and provide oversight and guidance as needed.
- Support vendor audits and broader vendor oversight programs focused on GCP compliance and quality performance.
- Monitor vendor-related CAPAs and quality improvement initiatives to ensure alignment with sponsor expectations.
- Partner closely with Clinical Operations, Clinical Development, Medical Affairs, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, Medical Writing, Data Management, Biostatistics, Clinical Supply, Information Technology, and Quality Assurance to coordinate inspection readiness activities.
- Provide inspection readiness guidance and best practices across all functional areas, ensuring consistent preparation and execution.
- Develop and deliver inspection readiness training tailored to various functional roles and responsibilities.
- Conduct mock inspections and coach subject matter experts on inspection expectations and effective interview techniques.
- Promote awareness and understanding of GCP regulations and inspection best practices throughout the organization.
- Manage regulatory inspection logistics, including scheduling, timelines, and communication plans.
- Coordinate regulatory document requests and ensure timely, accurate responses during inspections.
- Support inspection war room activities, including daily inspection debrief meetings and issue tracking.
- Prepare functional representatives for regulatory interviews through targeted coaching and mock interviews.
- Assist in developing inspection storyboards and executive briefing materials to ensure consistent and aligned messaging during inspections.
- Manage the TMF group, including direct oversight of at least one team member, providing leadership, coaching, and performance feedback.
- Work closely with executive-level leadership to provide strategic input on clinical compliance and inspection readiness for the organization's pipeline.
Essential Skills
- Bachelor"s degree in Life Sciences, Pharmacy, or a related scientific discipline.
- Minimum 8-10 years of experience in Clinical Quality Assurance, GCP Compliance, Clinical Operations, Inspection Readiness, or related quality functions within the pharmaceutical, biotechnology, or CRO industry.
- Minimum 3-5 years of experience leading inspection readiness initiatives or quality projects.
- Experience supporting sponsor organizations and global clinical development programs.
- Experience supporting FDA and/or international regulatory inspections.
- Strong knowledge of GCP regulations, inspection readiness best practices, and regulatory expectations.
- Demonstrated ability to lead cross-functional inspection readiness activities and governance.
- Proven experience conducting gap assessments, risk evaluations, and compliance assessments.
- Hands-on experience with Trial Master File oversight, including TMF health checks, quality review, and remediation.
- Familiarity with the TMF Reference Model and ALCOA+ principles.
- Experience managing CAPA processes, including root cause analysis, CAPA development, implementation, and effectiveness checks.
- Ability to collaborate effectively with CROs and strategic vendors on quality and inspection readiness.
- Strong communication, training, and coaching skills for preparing teams and subject matter experts for inspections.
- Demonstrated ability to monitor and interpret quality metrics, inspection trends, and compliance indicators.
- Clinical operations experience sufficient to understand end-to-end clinical trial processes and their impact on inspection readiness.
Additional Skills & Qualifications
- Certified Quality Auditor (ASQ CQA), RQAP-GCP, or an equivalent quality or GCP certification is preferred.
- Experience supporting multiple phases of clinical trials within an evolving pipeline.
- Experience working in a growing biotechnology or similar fast-paced environment.
- Demonstrated ability to work closely with executive-level leadership on strategic quality and compliance initiatives.
- Experience managing and mentoring TMF or clinical documentation teams.
- Strong organizational skills with the ability to manage complex inspection logistics and multiple concurrent priorities.
- Proactive mindset with a focus on continuous improvement and operational excellence.
Work Environment
This role operates in a remote work environment, with a preference for candidates who can align with Eastern Time Zone working hours. The position involves extensive virtual collaboration with cross-functional teams, external CROs, and strategic vendors, using standard clinical and quality systems and communication tools. Travel requirements are limited, providing stability and flexibility while still offering opportunities for occasional in-person collaboration or inspection support when needed. The work setting emphasizes a culture of continuous inspection readiness, operational excellence, and close partnership with executive leadership, offering a long-term opportunity to shape clinical compliance practices within a growing organization.
Job Type & Location
This is a Contract position based out of Brighton, MA.
Pay and Benefits
The pay range for this position is $84.00 - $89.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Aug 21, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
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