Compliance Manager, Clinical Quality Assurance Oversight

Work Schedule

Environmental Conditions

Job Description

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

Compliance Manager, Band 7

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.