Regional Clinical Manager - Lead CRA
(multiple positions available)
Job Code: CSA0416A
Clinical Managers (Lead CRAs) are responsible for the functional management
of the CTM portion of a Project Team (as part of a multi-disciplinary team,
or as a stand-alone project). This involves the integration of individual
tasks within the CTM portion of the Team to ensure that the CTM portion of
the Project is completed in accordance with the contract and that all
requirements of Good Clinical Practice (GCP) are satisfied. Acts as a
liaison with sponsors on CTM only projects and may assist the Project
Manager in client communications in multi-departmental projects. In the role
of CTM Core Team Member of a Project Team, works closely with, and receives
guidance from, the Project Manager (and/or Project Director if assigned) on
all Project related activities.
Position would be ideally based in: Austin, TX; Hartford, CT; Philadelphia,
PA; San Diego, CA; Boston, MA or Tampa, FL. Regionally based candidates may
be considered.
Primary Job Responsibilities
- With input and guidance from the Project Manager, manages, plans and
directs the assignments and activities of a portion of a Project Team
and is accountable to the Project Manager for these activities:
- Responsible for the quality, quantity and timeliness of work
performed by the CTM portion of a Project Team
- Provides general training in the performance of clinical trials
and, in conjunction with the Project Manager or Project Director,
provides study-specific training to CTM personnel
- Accompanies monitors on site visits to ensure study-specific
procedures are followed
- Monitors the preparation and timely completion of all regulatory
filing packages and monitoring trip reports and reviews them for
appropriate content
- Interacts and negotiates with third-party suppliers of products
and services used by CTM
- May perform direct Project tasks, such as monitoring, if needed, and
on a routine basis if other Project responsibilities allow
- Provides financial management for the CTM portion of assigned
projects and assists the Project Manager by providing monthly updates on
CTM's progress and performance with the project
- As a member of the Core Project Team, under the direction of the
Project Manager, participates in the development of an overall Project
Plan
- In conjunction with the Project Manager, evaluates and defines
client needs and expectations for CTM services and monitors team
performance vs. client expectations
- Contributes to Business Development by attending meetings with
potential sponsors; contributes time and cost estimates (and/or reviews
draft proposals for feasibility) for CTM-related activities
Key Skills
- Ability to effectively manage people
- Excellent communication skills( interpersonal, written, verbal)
- Detail oriented and well organized
- Fundamental understanding of strategy/trajectory and risk management
in drug development
- Demonstrated working knowledge of Microsoft Word, Excel and Access
- Ability to perform overnight business travel, up to 33%
Experience
- Minimum of four years experience in the pharmaceutical or related
industry in a clinical research capacity, two of which should be as a
SCRA or the equivalent
- Previous project management experience preferred
Education or Certifications
Minimum of a recognized undergraduate degree or RN is required, and a
degree in the biomedical sciences or an advanced academic degree or
equivalent is preferred
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