Associate Director designing and improving third party management processes in Global Clinical Operations. Ensuring compliance and efficiency in clinical operations objectives.
About the role
- Accountability for the GCP compliance oversight and control of regulated GCO activities focusing on GCO wide activities potentially having a high impact on GCO ability to deliver as per objectives, as per assignment.
- Provide GxP expertise and may be referred in providing GCP Compliance support to other functions, compliance, process, training and risk groups.
- Management of the GCO GCP audits and GCP inspections landscape and coordination of system/process audits & global inspections supporting authorizations including inspection readiness.
- Manage GCO wide systemic quality issues, deviations and quality events as per assignment, providing expertise in investigation, Root Cause Analysis (RCA) and Corrective And Preventive Action (CAPA) development.
- Involve and collaborate as needed with the relevant functions across GCO, GDD and the wider organization, such as Quality Assurance.
- Contribute to the maintenance of a centralized knowledge of audits/inspections related outcomes working closely with Training overseeing GCO Knowledge Management.
Requirements
- 8+ years industry experience specifically in clinical operations with an advanced knowledge 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.
- Strong skills to facilitate/optimize contribution of team members as individuals and members of a cohesive team.
- Strong capacity for working independently with minimal guidance.
- Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills.
Benefits
- Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Lead Clinical Operations Excellence initiatives at Roche to transform drug development through strategic project execution and alignment with patient needs. Drive continuous improvement across clinical trial processes.
ME
Medicines360Director, Clinical Operations
Director, Clinical Operations leading clinical trials for women's health devices. Overseeing study execution and collaborating with cross - functional teams for product commercialization.
IQ
Manager managing a team of clinical staff ensuring project objectives are met while supporting clinical studies. Leading staff allocation and training initiatives with a focus on quality and performance.
AC
Alcedis - a HUMA companyClinical Project Manager – Project Manager, Clinical Studies
Clinical Project Manager overseeing clinical drug trials and studies for major clients. Managing project planning, execution, and team coordination across multiple international sites.
Non - Clinical Operations Lead overseeing outsourced non - clinical studies at Organon. Responsible for collaboration and operational oversight in pharmacology, DMPK, and toxicology studies.
CA
CardioScanClinical Operations Administrator
Clinical Operations Administrator supporting echocardiography operations at CardioScan. Collaborating with clinical teams to ensure smooth scheduling and coordination of patient care.
WA
WGU AdvancementSupervisor, Clinical Operations
Supervisor of Clinical Operations for nursing students ensuring support at clinical sites in Charleston or Raleigh - Durham, NC. Develop relationships and supervise clinical faculty for successful student outcomes.
WA
WGU AdvancementSupervisor, Clinical Operations
Supervisor, Clinical Operations ensuring clinical sites support nursing students' practice needs with WGU oversight. Focus on developing relationships and coordinating clinical experiences within nursing programs.
HE
HealthHeroSupport Line Clinical Operations Manager
Manager handling Support Line clinical operations ensuring effective service delivery. Involves staffing, KPIs monitoring, and compliance within a healthcare context.