GCP Compliance Manager (Program & Study)

Job Description Summary

LOCATION: London or Dublin
ROLE TYPE: Hybrid Working, #LI-Hybrid
Relocation is not offered for this role
The GCP Compliance Manager (Program & Study) is accountable for the compliance oversight and control of regulated GCO activities focusing on program/trial level delivery as per program(s)/trial(s) assignment. This role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections as per program/trials’ selection and GCO self-strategy delivery.
The GCP Compliance Manager (Program & Study) is the single point of contact for Clinical Trial Teams for GCP Compliance, providing day-to-day support and ongoing quality oversight. This role promotes a product quality culture within GCO supporting the GCP Compliance Head (Program & Study), focusing on quality and compliance being increased and sustained and on active risk management.

 

Job Description

Major accountabilities:

• Accountable for the compliance oversight and control of regulated GCO activities focusing on

  program/trial level delivery as per program(s)/trial(s) assignment.

• Single point of contact for Clinical Trial Teams for GCP Compliance.

• As per focus area and assignment, management and day-to-day support provided in

  program/trial level quality issues, deviations and quality management.

• Coordination and support to Clinical Trial Teams for audits and inspections based on

  program/trial/country selection and scope.

• Delivery of the GCO self-assessment strategy related checks and controls.

• Support cross-functions risk assessments if programs or trials identified and contribute to the

  monitoring of relevant indicators/metrics/thresholds

Education Requirements: Advanced degree in science, engineering or relevant discipline.
 

Work Experience:

• 8+ years industry experience specifically in clinical

  operations and trial management with a strong

  understanding of clinical research international standards

  and regulatory requirements from Health Authorities.

  Audits and inspections experience highly desirable.

• Organizational and analytical skills associated with an

  aptitude in quality management and continuous

  improvement.

• Critical thinking ability and risk management and risk based knowledge and mindset.

• Ability in partnering with a proactive and solution-oriented

  mindset.

• Strong skills to facilitate/optimize contribution of team

  members as individuals and members of a cohesive team.

• Ability to work effectively in a matrix cross-functional

  environment.

• Strong capacity for working independently with minimal

  guidance.

• Ability to make & communicate difficult decisions,

  associated with strong written and verbal communication

  skills.

• Self-awareness, willingness to further develop own

  strengths and explore opportunities for improvement

Languages :

• English.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

 

Skills Desired

Budget Management, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trials, Collaboration, Data Analysis, Decision Making Skills, Health Sciences, Lifesciences, People Management, Regulatory Compliance