Multiple vacancies in Clinigene | Require Manager - Clinical Operations, Project Manager – Clinical Operations, Clinical Research Associate, Junior Executive, Project Physician

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Established in the year 2000 as a Biocon subsidiary, Clinigene became India's first CAP (College of American Pathologists) accredited Central Laboratory. Clinigene's services now span a broad spectrum of activities including human pharmacology, bioanalytical research, central laboratory, clinical operations, medical writing, medical monitoring, safety management, pharmacovigilance, clinical data management & biostatistics and regulatory services supporting early-phase through late-phase clinical development programs. We have extensive working knowledge of a wide range of products such as biologics, biotechnology products, vaccines, devices and small molecules. All activities are carried out in strict compliance with regulatory and ICH GCP requirements.

Post:

  • Manager - Clinical Operations { See Below }

Position: Manager - Clinical Operations

Job Description:
*Overall responsible for day to day activities of Clinical Operations.
*To be involved in designing and planning of clinical trials.
*To liaise with financial management of proposed and ongoing projects.
*Conduct feasibility studies for proposed clinical trials.
*Finalize the selection of sites and investigators.
*Provide clinical operations input to study protocol.
*Review recruitment strategies and timelines.
*Identify training needs and formalize training plan for clinical operation personnel.
*Identify areas of work within the department for new recruits.
*Prepare training program /schedule for the year.
*Check Clinical Trial Research SOPs and finalize list of SOPs provided by external sponsor.
*Quality System Management for relevant SOPs.
*Handling of the study proposals.
*Up gradation of site infrastructure.
*Coordinate with the legal department to finalize all relevant agreements and contacts necessary during the conduct of clinical trials.
*Arrange for Clinical Trial Liability Insurance.

Candidate Profile:
*Candidate should have strong leadership skills, strong verbal, written and interpersonal communication skills and knowledge of project management.
*Should be responsible for the development and implementation of clinical research processes and systems.

Additional Information:
Qualification:
Post graduate in life science / B.D.S / MBBS / MD / M. Pharmacy / B. Pharmacy
Experience: 8 - 10 years.
No. of Position: 2
Location: Bangalore

FORWARD YOUR CV TO: careers@clinigeneintl.com

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