Clinical Project Lead / Assistant Manager- Clinical Operations

5 - 10 years

10 - 20 Lacs

Thane, Mumbai (All Areas)

Posted:1 day ago| Platform: Naukri logo

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Skills Required

Clinical Operations sponsor communication monitoring clinical research clinical development vendor management project management Site Feasibility Site Selection Clinical Trials Site Initiation CRA Site Management Site Monitoring clinical project lead

Work Mode

Work from Office

Job Type

Full Time

Job Description

TroubleshootingSalient Features of this job * Chance to work in a supportive and flexible environment. * Directly interact with customers from the USA and Europe. * Vedic Lifesciences has been rated highly by our alumni last 22 years, as a great place to work and learn. Job Description: * Overall planning & management of Clinical trials. * Tracking trial progress, developing new study sites, project completion within agreed budget & timeline. * Identifying/selecting an Investigator & Vendor for the conduct of the trial. * Liaising with doctors/consultants or investigators on conducting the trial. * Setting up the trial sites, Training the study staff in SOP`s for CT * Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements. * Monitoring the trial throughout specified duration involving monitoring visit to the trial sites. * Source data verification * Review Investigators Brochure * Informed consent form review, case report form review, investigational drug accountability, and adverse event review. * Writing visit reports, filing and collecting trial documentation and reports * Stakeholder engagement * Sponsor communication * Team handling * Trouble shooting Pre-requisites for - Clinical Operations: * Medical / Life-sciences graduate with in-depth knowledge of Clinical Research project management & fluent English (oral and written) to communicate with global sponsors. * Having 5-8 years of project management in clinical research industry. * Ability to work independently in a complex matrix environment. Good project management skills. * Understanding of Good Clinical Practice. * Presentation, negotiation and conflict resolution skills. * Strong customer-oriented mindset * Ability to resolve issues with minimal supervision. * Willingness to act accountably in project/trial management. * Presentation, negotiation and conflict resolution skills. * Team Management, Good interpersonal skills.

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Vedic Lifesciences
Vedic Lifesciences

Clinical Research Organization (CRO)

Gurugram

51-200 Employees

2 Jobs

    Key People

  • Dr. Arun S. K. Chaudhary

    Founder & Managing Director
  • Mr. Rakesh Gupta

    Chief Operating Officer (COO)

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