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Clinical Research Manager

Analytic Recruiting Inc.

This is a Contract position in South Brunswick, NJ posted March 26, 2020.

Global Diagnostics company seeking Clinical Research Manager to lead the activities for various programs as well as manage all activities associated with performing clinical trials.

Location: New Jersey Responsibilities: -Writing and finalizing protocols for the conduct of interventional clinical trials and non-interventional trials and studies designed for the retrospective collection of data.

– Identifying, selecting and qualifying sites to conduct clinical trials.

– Reviewing informed consent forms and other documents, ensuring that all regulatory requirements are met.

– Performing site visits including monitoring activities as needed/assigned, insuring the clinical trial is being performed according to ICH/GCP guidelines and meeting the protocol requirements.

– Planning, coordinating, and facilitating investigator meetings.

– Communicating with study centers, addressing issues and disseminating study trial information.

-Training investigators, monitors and site personnel to ensure appropriate collection and reporting of non-serious and serious adverse events, as well as special situations, and any urgent safety measures taken by the site during the study.

– Assisting with data flow and query resolution.

-Requesting and managing clinical supplies, including coordinating the shipment of the clinical supplies to study sites,
– Over-seeing drug accountability and the return of clinical supplies.

– Managing vendors and consultants
– Creating and maintaining the TMF Initiating payments to investigators
– Ensuring that projects keep within their approved budget.

-Communicating critical study-related or personnel issues to the Head of Worldwide Clinical Research in a timely manner Professional Experience
– 3 years Clinical Research/Management experience with demonstrated experience in multinational and/or multi-site clinical studies.

– Knowledge of GCPs, CFR, ICH and EU guidelines.

– Ability to manage several projects simultaneously.

– Experience in diagnostic imaging field is preferred.

– Education
– Medical Degree (NP, MD, RN) Key words: clinical research, clinical trials, diagnostic imaging, life sciences Please refer to Job 23823 and send an updated resume to