Manager, Protocol Data Management

PRIMARY RESPONSIBILITIES

  • Include the receipt and abstraction of protocol and/or contact information into the appropriate databases for use by the client and their collaborators in support of clinical trials.
  • Respond to phone or email queries regarding standard processes associated with the abstractions.
  • Assist in the preparation of contract required reports.
  • Participate in the revision of SOPs and work instructions as necessary and appropriate.
  • Handle special client requests as assigned.
  • Other duties as assigned.

EDUCATION/REQUIREMENTS

  • B.S. or B.A. degree or equivalent related experience. Medical background a plus.
  • Two to five (2 - 5) years regulatory or relevant work experience. Minimum of the three (3) years in clinical research management (i.e. clinical protocols, clinical projects, clinical research); five (5) years preferred.
  • Exposure to GCPs and clinical trials is required.  
  • Background in clinical or protocol operations required.
  • Solid understanding of medical, protocol data and scientific research and literature.
  • Ability to manage data in various systems.  
  • Ability to delegate tasks, developing a workflow process to ensure quality and accuracy of staff work products, reviewing deliverables and mitigating any risks.
  • Thorough understanding of the critical process, managing the process plan, deadlines and regulations.
  • Identifying any potential risks.
  • Implementing and working within an overall risk management plan.
  •  At all times, maintains clients’ confidentiality and discretion as it relates to sensitive documents and information.
  • Experience with creating and updating SOPs a plus.
  • Excellent Excel skills (i.e. manipulating data) required.
  • Experience using Microsoft Office.
  • Excellent oral, written, interpersonal and organizational skills.
  • Provides client customer service in a timely manner.