Clinical Operations Project Manager in Cambridge, MA at Signature Consultants

Date Posted: 9/11/2019

Job Snapshot

Job Description

Clinical Operations Project Manager Summary:

Signature Consultant has an opportunity for a Clinical Operations Project Manager. Our client is seeking an individual to be responsible for all IT clinical project implementations and operational aspects of clinical systems in compliance with GCP's, SOPs and standards. The major initiative will be leading is the evaluation and implementation of clinical trial software systems (Veeva, Medidata Clinical Cloud, IQVIA, etc.). The candidate will be overseeing this from start to finish, vendor evaluation/relations, user requirement gathering, planning & coordinating, implementation & post-implementation.

Qualifications:

  • Experience in supporting IT needs for clinical operations, including trial planning and execution according to study objectives, timelines and budget. Systems include EDC, eTMF, CTMS Study Start up, Adverse Events, QMS, LIMS and CAPA system
  • Ensure GCP compliance and consistency for clinical IT systems
  • Deep understanding of clinical development within one or more Phases of trials (Phase I, II, III, IV) and a working understanding of cross functional drug development
  • Scientific learning agility to quickly develop a sound working knowledge of new therapeutic areas
  • IT vendor relationship management
  • Manage RFP/RFB's
  • Understand business operations, effectively communicate with key business stakeholders

About Signature Consultants, LLC

Headquartered in Fort Lauderdale, Florida, Signature Consultants was established in 1997 with a singular focus: to provide clients and consultants with superior staffing solutions. For the ninth consecutive year, Signature was voted as one of the "Best Staffing Firms to Work For" and is now the 15th largest IT staffing firm in the United States (source: Staffing Industry Analysts). With 27 locations throughout North America, Signature annually deploys thousands of consultants to support, run, and manage their clients' technology needs. Signature offers IT staffing, consulting, managed solutions, and direct placement services. For more information on the company, please visit www.sigconsult.com.