Clinical Project Manager - EAST COAST USA
- Experience Level
Upsilon Global are working with a mid size international CRO that specializes in oncology and immuno-oncology and rare diseases studies in Phase I-III. Their headquarters are in the US and have a number of offices located across the US. As a CRO they focus on quality of the studies and in working with mid-size pharmaceuticals and biotechs. The CRO prides itself of the ongoing training they offer and the low staff turnover of 7% across the whole company.
- Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations
- Liaise with Project Team and senior management of both Precision and sponsors, including C level
- Handle and lead all aspects of a clinical research trial or trials
- Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
- Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
- Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials
- Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets
- Bachelor's degree or equivalent experience
- PMs: 5+ years of clinical trial experience in pharmaceutical, biotech or CRO, including at least two (2) years in oncology
- Sr PMs: 7+ years in clinical operations, data management or related discipline in CRO or pharmaceutical industry to include people management
- Working understanding of GCP/ICH guidelines and the clinical development process
- Ability to drive and availability for domestic and international travel including overnight stays
- Proven computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
- Proven ability to develop positive working relationships with individual and teams internally and externally
- Demonstrated core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan
- Masters programs with concentration in a scientific or healthcare discipline
- Understanding of financial management, shown ability to identify changes in scope and successfully address those changes appropriately
- CRO experience
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