GCP Compliance Manager (Program & Study)

London - UK

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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

Required Experience:

Manager

Job Description SummaryLOCATION: London or Dublin ROLE TYPE: Hybrid Working #LI-HybridRelocation 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 p...