Manager, Protocol Data Management
- 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.
- 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.