Published: 25 April 2024
GCP Compliance Manager (Program & Study)
Basel
100%
Permanent position
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GCP Compliance Manager (Program & Study)
Novartis AG
Publication date:
25 April 2024Workload:
100%Contract type:
Permanent positionPlace of work:
Basel
GCP Compliance Manager (Program & Study)
About the Role
Location: Basel, Switzerland (Onsite/Hybrid)
#LI-Onsite #LI-Hybrid
We are seeking a GCP Compliance Manager (Program & Study) to be accountable for the compliance oversight and control of regulated Global Clinical Operations (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.
This role will work directly with the Process, Training & GCP Compliance, Global Clinical Operations team and reports to the GCP Compliance Head (Program & Study).
Key Responsibilities:
• Accountable for the compliance oversight and control of regulated GCO activities focusing on program/trial level delivery as per program(s)/trial(s) assignment.
• Acting as single point of contact for Clinical Trial Teams for GCP Compliance.
• As per focus area and assignment, management and day-to-day support provided program/trial level quality issues, deviations and quality events 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.
• Supporting cross-functions risk assessments if programs or trials identified and contribute to the monitoring of relevant indicators/metrics/thresholds.
• Contributing to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (Program & Study).
• Driving 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, involving and collaborating as required with GDD and the wider organization, such as Quality Assurance.
#LI-Onsite #LI-Hybrid
We are seeking a GCP Compliance Manager (Program & Study) to be accountable for the compliance oversight and control of regulated Global Clinical Operations (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.
This role will work directly with the Process, Training & GCP Compliance, Global Clinical Operations team and reports to the GCP Compliance Head (Program & Study).
Key Responsibilities:
• Accountable for the compliance oversight and control of regulated GCO activities focusing on program/trial level delivery as per program(s)/trial(s) assignment.
• Acting as single point of contact for Clinical Trial Teams for GCP Compliance.
• As per focus area and assignment, management and day-to-day support provided program/trial level quality issues, deviations and quality events 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.
• Supporting cross-functions risk assessments if programs or trials identified and contribute to the monitoring of relevant indicators/metrics/thresholds.
• Contributing to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (Program & Study).
• Driving 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, involving and collaborating as required with GDD and the wider organization, such as Quality Assurance.
Role Requirements
Essential Requirements:
• Advanced degree in science, engineering or relevant field.
• 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 a proficiency in quality management and continuous improvement.
• Critical thinking ability and risk management and risk-based knowledge and approach.
• Ability in partnering with a proactive and solution-oriented approach.
• 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.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Advanced degree in science, engineering or relevant field.
• 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 a proficiency in quality management and continuous improvement.
• Critical thinking ability and risk management and risk-based knowledge and approach.
• Ability in partnering with a proactive and solution-oriented approach.
• 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.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network(link is external)