Compliance Manager – Clinical Quality Assurance Oversight

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee and provide support for Clinical Quality to clinical study teams.

• Act as the primary Quality contact for the client.

• Collaborate with Operations to foster a unified Quality culture across studies or portfolios.

• Engage in regular partnership-level and ad hoc team meetings.

• Offer guidance and recommendations to prevent issues.

• Maintain ongoing awareness and perform periodic reviews of QE, SSM, SB, sPIP, audits, and inspection activities.

• Appropriately escalate issues to Client Quality, Quality Partner, Strategic Alliance Lead, bPL, PDL, or OD to minimize client impact and enhance outcomes.

• Facilitate and enable Quality Risk Management.

• Prepare and analyze QA-related KQIs to identify emerging trends and potential risks.

• Collaborate with Clinical Operations and PV to assess and mitigate risks related to participant safety and reporting compliance.

• Analyze trends in SAE reporting timeliness, safety-data reconciliation, and PV vendor performance, and support necessary follow-up actions.

• Ensure compliance with client-specific requirements regarding quality events, audits, and responses to inspections.

• Integrate quality insights into operational lessons learned and promote awareness throughout the portfolio.

• Advocate for Partnership Governance.

• Co-chair Joint Quality Councils and participate in other governance meetings.

• Present quality metrics and trends, discussing potential resolutions with relevant stakeholders.

⛳️ Requirements

• A bachelor's degree is mandatory.

• In certain cases, a combination of relevant education, training, and/or directly related experience may be deemed sufficient.

• A minimum of 8 years of relevant experience, or an equivalent combination of education, training, and experience is required.

• A solid understanding of GCP is essential.

• Demonstrated experience in building strong relationships is necessary.

• Experience with CRO and/or Pharma companies is required.

• Preferably, experience collaborating with PV or Drug Safety teams in clinical development, including support for safety-reporting processes and follow-up on PV-related quality events, audit findings, or corrective and preventive actions.

• Comprehensive knowledge of FDA and EU regulations related to Clinical Trials and ICH Guidelines is expected.

• Up-to-date and strong understanding of Clinical Development processes according to GCP and regulatory requirements is important.

• Ideally, familiarity with pharmacovigilance requirements pertinent to clinical trials, including ICH E2A and applicable FDA and EU safety-reporting mandates.

• Ability to identify and escalate PV quality and compliance risks regarding serious adverse event reporting, safety-data reconciliation, reporting timelines, and oversight of PV vendors or partners is preferred.

• Capacity to inspire and educate clinical study teams on clinical quality matters.

• Skill in establishing effective relationships with both internal and external stakeholders.

• Ability to convey quality culture and operational practices to study teams.

• Fully remote position, ideally within Central time zones.

• Relocation assistance is NOT available.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• 0–25% travel may be required.

• Relocation assistance is NOT provided.