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Our client, a growing diagnostics company located in central New Jersey is in search of the following professional:
Senior Manager, Clinical Research
Writing and finalizing protocols for the conduct of interventional clinical trials and non-interventional trials as well as studies designed for the retrospective collection of data.
Selecting and qualifying sites for the performance of clinical trials.
Reviewing informed consent forms and other Trial Master File (TMF) documents, insuring 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 (e.g., central ECG and lab services).
Insuring that all project information is up to date in CTMS (e.g. monitoring visits; enrollment).
Tracking enrollment for each site; proactively addressing issues, insuring protocol compliance.
Creating and maintaining Trial Master File
Initiating payments to investigators
Overseeing payments to vendors: reviewing invoices including documentation supporting pass through costs
Submitting SUSARs to ECs and Investigators as needed.
Qualifications: B.S./B.A. degree. 3+ years Clinical Research/Management experience with demonstrated experience in multi-national and/or multi-site clinical studies. Knowledge of GCPs, CFR, ICH and EU guidelines. Ability to manage several projects simultaneously.
Highly competitive base salary plus benefits and incentives.