Clinical Project Manager - EAST COAST USA

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.

Responsibilities:

• 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

Qualifications:

Minimum Required:

• Bachelor's degree or equivalent experience

Other Required:

• 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

Preferred:

• 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