Clinical Study Manager

South San Francisco, CA 94080

Posted: 03/27/2019 Industry: Other Area(s) Job Number: 34486

Clinical Study Manager (CSM)

The Clinical Study Manager (CSM) provides day to day clinical operations management of a clinical trial. Attends the study management team (SMT), may manage vendors, clinical monitors and clinical trials sites.

Responsibilities

• May assist in reviewing clinical study protocols, informed consents, case report forms, monitoring plans, clinical study reports and other study-related documents

• Assists in development of clinical studies and respective docum

• May act as one of the primary contacts between the company and multiple clinical sites

• Maintains close contact with sites by telephone, correspondence and on-site visits as required

• Assists in preparing CROs, vendors, CRAs for a site monitoring visit to assure compliance with the study protocol, clinical trial material storage and accountability, GCP and FDA or other Health Authority regulations, and overall clinical objectives

• Ensures preparation, management and participation in investigator meetings when required

• Instructs investigators, study coordinators and their personnel regarding site compliance with the routine protocol, regulatory requirements and quality of data

• Supports the training of Clinical Study Associates and / or be assigned as a buddy to colleagues

• Interfaces, co-ordinates and addresses routine study issues with individuals in other functional area

• Supports the availability of clinical trial documentation and retrieves, processes and tabulates clinical or study compliance data to ensure smooth initiation, operation and timely completion of the clinical trial

• Verifies accuracy of clinical data through comparison of the case report forms to patient records at the site and identifies and escalates discrepancies

• Supports review of routine data, and preparation of safety, interim, and final study reports, and resolution of data discrepancies

• Provides input into the selection of and grant contract negotiation with investigational sites and may conduct site training for the study

• Supports the resolution of routine monitoring issues • Provides Clinical Operations guidance for complete and accurate databases for clinical studies

• Supports analyses of study data and prepares clinical summaries as needed to support claims of safety and efficacy

• Provides input in the setting and updating of study timelines for vendors

• Provides input in CRO or vendor selection

• Interacts with CRO personnel as needed and may oversee CRO management of 1-2 regions of a clinical trial • May manage one or more vendors for clinical trials in accordance with budgets and scopes of work.
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