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Miles
Km80.5

Clinical Trials Manager

ArmaGen Technologies

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Location: Calabasas, CA Posted Date: 5/1/2013 Position Type: Full time Job Code: Clinical Trials Manager Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Research

Description

Clinical Trials Manager Job Purpose:
Execution of Phase 1 and POC clinical studies in the lysosomal storage disease area

Clinical Trials Manager Job Duties:
1. Assume overall responsibility for the preparation of protocols and Case Report Forms, finalization of monitoring and data management options (either in-house or contracted to a Contract Research Organization), Ethics committee approval, development of recruitment strategies to increase patient randomization into the trial, the provision of clinical trial materials, and management of the trial.
2. Ensure that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
3. Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion.
4. Participate on corporate global clinical research teams ensuring that colleagues are updated on all relevant issues.
5. Ensure the smooth running of the clinical research department by developing systems to track projects including all study, investigator and ethical review board information, patient recruitment activity and financial management.
6. Have responsibility for the financial management of the clinical trial program including budget planning, resource allocation and preparation of quarterly reports.
7. Execute project management, site communication, protocol and CRF writing, adverse event reporting and pharmacovigilance, and budget control and reporting.

Requirements

Start-up experience
3 to 5 years
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