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.

Role & responsibilities Identifying/selecting an investigator who will be Responsible for The conduct of The trial at The trial site. Liaise with doctors/consultants or investigators on conducting the trial. Setting up The trial sites, which includes ensuring each centre has The trial materials, including The trial drug often known as The investigational medicinal product. Training The study staff in standard operating procedure for The clinical trials as per applicable regulatory requirements. Verify that investigator and investigators team are adequately trained and comply with The protocol. 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 Informed consent form review, case report form review, investigational drug accountability, and adverse event review. Ensuring all unused trial supplies are accounted for. Writing visit reports, filing and collecting trial documentation and reports. Preferred candidate profile Pre-requisites for - Sr. Project Executive / CRA / Sr. CRA: B. Pharm/ BSc / Biotech + Clinical Research Degree / Diploma / Masters Candidate must possess excellent communication skills and ability to build excellent relationships with the trial staff and colleagues. ICH-GCP knowledge is a must. Ready to travel within and out of Mumbai at various trial sites. Willing to travel 50-60%. Attention to detail Good organisational and administrative skills (knowledge of word and Excel) Perks and benefits Salient 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