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Lambda Therapeutic Research
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Assistant Manager - SARC (Scientific Affairs & Regulatory Compliance)

Assistant Manager - SARC (Scientific Affairs & Regulatory Compliance)

Lambda Therapeutic Research

5 - 10 years

7 - 12 Lacs

ahmedabad

Posted:18 hours ago| Platform:

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Skills Required

cro manager quality assurance compliance process efficiency pharma clinical trials regulatory compliance clinical research associate monitoring srm

Work Mode

Work from Office

Job Type

Full Time

Job Description

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

Site Report Management (SRM) - Clinical Trial Operations Review and approve of SVRs for assigned studies and ensure compliance to standard documents as applicable to individual study.
Review SVRs to ensure quality, document findings requiring corrective and preventive actions and follow up till resolution.
Review and approval of SVRs in timely manner as per defined process.
SVRs annotation preparations, finalization and intigration in system in a timely manner.
Training to CRAs for finalized annotations of SVRs.
Guide the CRAs for writing good quality visit reports and ensure that documentation related to action items and protocol deviations as appropriate.
Periodic meetings with study team for discussion of relevent stuay activities as applicable.
To identify and escalate issues related to CRAs or site, data trends and risk factors to the project managers in a timely manner.
Mentoring trainee/ newly joined CRAs.
Give inputs for improving process efficiency.

EXPERIENCE

At least 5 years experience in clinical trials as CRA (Clinical Research Associate)/SRM (Site Visit reports reviewer) /CM (Central Monitor)/ QA (Quality Assurance).

EDUCATIONAL QUALIFICATION

M. Pharm, B. Pharm, M. Sc, BHMS, BDS, BAMS

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Assistant Manager - SARC (Scientific Affairs & Regulatory Compliance)