GCP Compliance Manager, Program & Study

Novartis; United Kingdom; Hybrid; GBP 40,000 - 60,000

Job description

Job Description Summary
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:

1. Accountable for the compliance oversight and control of regulated GCO activities focusing on program/trial level delivery as per program(s)/trial(s) assignment.
2. Single point of contact for Clinical Trial Teams for GCP Compliance.
3. Management and day-to-day support provided in program/trial level quality issues, deviations and quality events management.
4. Coordination and support to Clinical Trial Teams for audits and inspections based on program/trial/country' selection and scope.
5. Delivery of the GCO self-assessment strategy related checks and controls.
6. Support cross-functions risk assessments if programs or trials identified and contribute to the monitoring of relevant indicators/metrics/thresholds.

Activities & Interfaces

1. Contribute to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (Program & Study).
2. Drive the compliance oversight and control of regulated GCO activities focusing on program/trial level delivery as per program(s)/trial(s) assignment, working closely with the Clinical Trial Teams and the relevant functions across GCO.
3. Manage and provide day-to-day support to the Clinical Trial Teams in program/trial level quality issues, deviations and quality events management.
4. Coordinate and support audits and inspections based on program(s)/trial(s)' selection and audit/inspection scope.
5. Deliver the GCO self-assessment strategy related checks and controls as assigned.
6. Support cross-functions risk assessments if program(s) or trial(s) identified.
7. Contribute to the monitoring of relevant indicators/ metrics/thresholds ensuring the detection of unreported issues, trends and early signals of risks at program/trial delivery level.
8. Participate in relevant GCO, PCT, GCP Compliance team meetings.
9. Contribute to build a network of managers and other relevant stakeholders with other functions, compliance, process, training and risk groups across GCO.
10. Promote a compliance culture within GCO, advocating the adherence to highest standards and ethical integrity.

Key performance indicators:

1. Compliance of regulated GCO activities, with increased oversight and control.
2. Increased capabilities through time with a strong support provided to Clinical Trial Teams.
3. Timely delivery of the GCO self-assessment strategy related checks and controls.
4. Contribution in potential impact mitigations related to the product quality and compliance.
5. Support Process, Training & GCP Compliance objectives' achievement.

Education (Minimum): Advanced degree in science, engineering or relevant discipline.

Languages: Proficiency in English.

Experience/Professional requirement:

1. 8+ years industry experience specifically in clinical operations and trial management.
2. Organizational and analytical skills associated with an aptitude in quality management and continuous improvement.
3. Critical thinking ability and risk management knowledge.
4. Ability in partnering with a proactive and solution-oriented mindset.
5. Strong skills to facilitate/optimize contribution of team members.
6. Ability to work effectively in a matrix cross-functional environment.
7. Strong capacity for working independently with minimal guidance.
8. Ability to make & communicate difficult decisions.
9. Self-awareness, willingness to further develop own strengths.

Location: UK Homeworker or if based in Ireland (hybrid 12 days per month in office)

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

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