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 Job #02651 Email this job to a friend
About our client
Our client is a leading medical technologies company that has developed a reputation for producing life-enhancing products in the areas of cardiology, oncology and urology. The company has a 100-year history of success, including growing over 30% in 2007. With an experienced management team and an empowering corporate culture that is focused on the professional development of its employees, this is a strong opportunity for the right candidate!
Position Location
Clinical Research Associate Manager New Jersey
Salary Reports To
Highly competitive package, commensurate with experience
Responsibilities
1) Oversee the quality of clinical trial monitoring activities at the company
2) Liaise with external CRAs
3) Manage contract CRA with respect to clinical trial operations
4) Ensure the overall quality of clinical trials along with the integrity of data by developing procedures
5) Monitor plans and supervise (closely) CRAs
6) Ensure investigator adherence to the protocol, essential document collection and clean data
7) Act as a liaison to field questions and address issues reported by external CRAs
8) Work closely with Project Manager(s) to communicate trial progress and quality as well as contract CRA performance
9) Maintain regular communication with CRAs to discuss/resolve issues in a prospective manner
10) Discuss clinical operation issues and recommend corrective action (where needed)
11) Provide reports to divisional project managers and corporate management (as requested)
Requirements
1) BS/BA/higher degree in a related scientific area/clinical degree such as RN preferred
2) Minimum 5 years of experience in a related device/pharmaceutical field monitoring
3) Experience in management
4) Good leadership abilities
5) Problem-solving skills at strategic and operational levels
6) Knowledge of operational aspects of clinical research and regulatory requirements
7) Ability to multi-task in a fast-paced environment
8) Ability to discuss strategic and sensitive issues
9) Ability to work with minimum supervision
10) Excellent communication (verbal and written) skills

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