Senior Clinical Project Manager
Posted on Sep 12, 2019 by Job Juncture
This is a fast-paced, hands-on position seeking a confident project-focused clinical expert, and ready to take on more responsibility.
- Initiate, design and coordinate studies; collecting data to support submissions to regulatory and future product development
- Ensure the execution of clinical trials with the goal of adhering to target timelines, budget and quality
- Operate at a high level independently, partnering with other CRAs internally and directly reporting to the Director of Clinical/RA
- Manage clinical trials; protocol, ICF and CRF development, investigational product/supply management, budget/contract negotiation and regulatory document collection/management
- Monitor studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, utilizing knowledge of the diagnostic area sufficient to perform source data verification and monitor study protocol conduct/compliance
Senior Clinical Affairs Project Manager
Competitive Pay, 8% bonus, 6% 401k, 4 weeks PTO
Relocation assistance available
What makes this role unique: A 10+ year client of ours has acquired an exciting technology company and is ramping up to commercialize the product; development, research, mfg, engineering, operations, clinical, regulatory, etc - all of this ground-floor opportunities to create & build, but have the stability of working for a multi-billion dollar profitable business! Start-up feel, big-business backing and support. This role is within a leading medical diagnostic company, that offers cutting edge technology, machines, and rapid testing solutions at physicians' fingertips.
- Bachelor's Degree in life science discipline desired, other degrees will be considered
- Min 10 years of Clinical experience with minimum 5+ years project management experience in clinical research/trial management in a hospital, lab, or R&D environment. Must have sponsor experience.
- CCRA certification with ACRP or SoCRA desired
- Demonstration of strong writing skills in all job responsibilities (eg protocols, monitoring reports, correspondence, clinical trial reports, etc.)
- Demonstration of effective oral communication skills with clinical sites, and internal/external personnel from various departments/levels
- Ability and willingness to travel, domestic and international, depending upon project need, periodically up to 30-50% domestically
- Experience with Pre-Subs and 510k submissions desired but not required