Clinical Project Manager leading the planning and execution of Global Drug Development studies for Novartis in China. Collaborating with various teams to ensure compliance and timely delivery of studies.
About the role
- Non-Clinical Operations Lead overseeing outsourced non-clinical studies at Organon. Responsible for collaboration and operational oversight in pharmacology, DMPK, and toxicology studies.
Responsibilities
- Direct engagement with preclinical CROs to oversee the conduct of non-clinical studies to support Organon’s pipeline projects
- Maintain collaborative CRO vendor relationship for effective conduct of non-clinical studies
- Conduct virtual and on-site qualification of new and existing non-clinical vendors and coordinate with Quality Assurance as appropriate
- Conduct on-site study monitoring at key study milestones
- Contribute to operational responsibilities of the non-clinical function, including authorship of SOPs and/or policies
- Interface with Organon Procurement for vendor contracts and financial statements
- Track and coordinate non-clinical resources applied to outsourced activities/studies
Requirements
- BS, MS, PhD, or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences
- Minimum of five years of experience in the pharmaceutical or biotech industry
- Extensive and in-depth knowledge of the operational conduct of in vitro and in vivo non-clinical studies, including toxicology, DMPK and pharmacology studies
- Demonstrated knowledge of GLP requirements and ability to assess implementation of GLP practices
- Experience with on-site study monitoring and qualification of vendors and facilities
- Specific experience in monitoring pivotal toxicology studies is required
- Experience with animal handling procedures and ethical practices
- Exhibits effective communication and collaboration, integrity, and respectful interactions with Organon personnel
- Excellent organizational and interpersonal skills
- Ability to work independently
Benefits
- retirement savings plan
- paid vacation and holiday time
- paid caregiver/parental and medical leave
- health benefits including medical, prescription drug, dental, and vision coverage
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