Clinical Data Manager

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Teaneck, New Jersey

Post: Thu, 29 Sep 2022 03:30:21 GMT

Expires: Thu, 27 Oct 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Responsibilities:

Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ increasingly complex central laboratory studies

Provide leadership to CDM team.

Manage CDM customer relationship for CDM project team to include leading (with minimal guidance) CDM customer negotiations on complex timeline, budgetary and other issues.

Provide marketing capabilities presentations and business development presentations. . Or serve as Data Operations Coordinator (DOC) for one or three global clinical trials with fewer than 25 operations staff (excludes DE) or 20-40 central laboratory studies, or serve in a leadership role to a specific DM Task.

Serve as back-up for Data Operations Coordinator or Data Team Lead

Provide leadership to Operations team

Provide technical expertise. Or serve as a Subject Matter Expert (SME)

Provide leadership and expertise in a specific CDM task or technology. Manage delivery of projects through full data management process life-cycle.

Management of: Project timelines, Quality issues, Resource management

SOW (scope of work) / budget.

Provide justification for customer negotiations. May serve as Project Manager for single service data management projects.

Manage comprehensive data management tasks pertaining to the documented project specifications.

Manage comprehensive quality control procedures.

Provide data management expertise and data management process improvement to CDM management.

Mentor other team members in training and developing data management expertise.

Independently bring project solutions to the CDM team and the CDM Department. Manage a focus team or a best practice team.

Manage the development and implementation of new technology/tool.

Present at professional conferences and/or publish articles in professional journals.

Provide CDM with technical expertise.

Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.

Perform other duties as directed by the functional manager.

Develop and maintain good communications and working relationships with CDM and project teams.

Requirements:

Bachelor’s Degree clinical, biological or mathematical sciences, or related field or nursing qualification required

5 years relevant experience including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials >1000 patients, and including experience handling customer negotiations (e.g. bid defense meetings). Equivalent combination of education, training and experience.

Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology.

Knowledge of operating procedures and work instructions and the ability to apply them in practice.

Excellent experience and organizational, communication, and demonstrated expert data management skills.

Comprehensive understanding of clinical drug development process (detail oriented).

Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology.

Knowledge of operating procedures and work instructions and the ability to apply them in practice.

Excellent experience and organizational, communication, and demonstrated expert data management skills.

Comprehensive understanding of clinical drug development process (detail oriented).