Job Description

PPD, the Clinical Research business of Thermo Fisher Scientific is hiring for a Compliance Manager in our global Clinical Quality Assurance group.

What will you do in this role?

• Provide Clinical Quality oversight and support of the clinical study teams.
• Dedicated, single point of Quality contact for client.
• Partners with Ops to establish a consistent Quality culture across the studies or portfolio.
• “Seat at the table” for regular partnership level and ad hoc team meetings.
• Provide directions and recommendations for issue avoidance.
• Continuous awareness and periodic review of QE/SSM/SB/sPIP/Audit/ Inspections.
• Escalate appropriately to Client Quality/Quality Partner/Strategic Alliance Lead/bPL/PDL/OD to minimize client impact and improve outcomes.
• Enable and facilitate Quality Risk Management.
• Prepare and analyze QA-related (e.g., QE, Audit, inspection) KQIs for emerging trends and potential risks to mitigate/prevent issues.
• Partner with Clinical Operations and PV to identify, assess, and mitigate risks to participant safety and reporting compliance; review trends in SAE reporting timeliness, safety-data reconciliation, and PV vendor performance, and support follow-up actions.
• Promote compliance (i.e., timeliness, consistency, and accuracy) of client-specific requirements related to quality events/audit/inspection responses.
• Incorporate quality insights into operational lessons learned and promote awareness across the portfolio. Speaks to such.
• Drive support Partnership Governance.
• Co-chair Joint Quality Councils and is available to contribute to other governance meetings.
• Present quality metrics/trends and discuss potential resolution as required with relevant stakeholders.

Qualification Requirements:

Education Requirements:

Bachelor's degree is required.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Experience requirements:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, & experience.

Working knowledge of GCP is required.

Proven experience in building strong relations is required.

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

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

Knowledge, Skills and Abilities:

• In‐depth knowledge of all Clinical Trial related FDA and EU regulations and ICH Guidelines.
• Current and strong knowledge of Clinical Development processes according to Good Clinical Practices (GCP) and regulatory requirements.
• Preferably has working knowledge of pharmacovigilance (PV) requirements relevant to clinical trials, including ICH E2A and applicable FDA and EU safety-reporting requirements.
• Ideally, can recognize and escalate PV quality and compliance risks involving serious adverse event (SAE) reporting, safety-data reconciliation, reporting timelines, and PV vendor or partner oversight.
• Ability to motivate and educate the clinical study team on clinical quality aspects.
• Capable of building effective relationships with internal and external stakeholders.
• Ability to translate quality culture and ways of working to study teams.

0-25% travel may be required.

Location: Fully remote, ideally Central time zones. Relocation assistance is NOT provided.