Manager, Protocol Data Management
Job Description: Primary responsibilities include managing team of 5-7 Clinical Information Specialists; oversight of the daily operations of the team that includes but is not limited to 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; responsible for establishing and maintaining good communications with the external and internal stakeholders; responds to phone or email queries regarding standard processes associated with the abstractions; provides oversight for preparation of contract required reports; evaluates and analyses data to provide ad hoc reports per clients’ requests; responsible for revision of SOPs and work instructions annually and as needed; handles special client requests and other duties as assigned.
Requirements: B.S. or B.A. degree or equivalent related experience. Medical background a plus; minimum of the three (3) years in clinical research management (i.e. clinical protocols, clinical projects, clinical research); five (5) years preferred. background in GCP, clinical or protocol operations, and data management concepts is required; solid understanding of medical, protocol data and scientific research and literature; ability to manage data in various systems and databases; 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, identifying and working within an overall risk management plan; experience with creating and updating SOPs required; excellent Excel skills required; experience using Microsoft Office required; excellent oral, written, interpersonal and organizational skills, as well as communication and client management skills are require; provides client customer service in a timely manner; at all times, maintains clients’ confidentiality and discretion as it relates to sensitive documents and information.