Clinical Project Lead / Assistant Manager- Clinical Operations Vedic Lifesciences

5.0 - 10.0 years

10 - 20 Lacs

Thane, Mumbai (All Areas)

Work from Office

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.

Posted 1 month ago

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