Clinical Research Manager

Waltham, MA

Posted: 08/28/2019 Employment Type: Contract Industry: Life Sciences Job Number: 230302

Clinical Research Manager
Contract to Perm
Waltham, MA

 Job Description:
  • Clinical Research Manager for Investigator Sponsored Trials and will be responsible for establishing strong partnerships with internal and external teams including investigators, MSLs, committee members and other partners.
  • Ensures timely communication and information sharing occurs between cross functional groups and study sites as appropriate.
  • Contributes to creation of study drug and budget projections
  • Stores documentation necessary for auditing purposes
  • Consolidating key performance indicators 

 Job Requirements 
  • BS/RN/RPh degree with progressive experience in Medical Affairs and/or Clinical Operations.
  • Demonstrated knowledge of protocol in oncology studies.
  • Knowledge of FDA, ICH, GCP, and OIG guidelines.
  • Understanding of cross-functional clinical processes including biostatistics, medical writing, drug safety, regulatory affairs, legal, clinical supply, medical affairs and scientific R&D. 
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