Assistant Project Leader

Konnect HR
  • Mumbai
  • Confidential
  • 3-7 years
  • Views
  • 29 Mar 2018

  • Medical Services

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Responsibilities : - Inviting proposal for clinical trials - Selection of CROs for clinical trials - Review of Clinical trial protocols - Preparing and conducting pre-study activities, site selection, initiation visits, routine monitoring and close-out visits - Performing feasibilities - Preparing applications to ethics committees and supporting the regulatory department with the application to the regulatory authorities - Planning and participating at Investigator's meeting(s) - Responsible for the site(s) and on-site management during the study process - Ordering and coordinating study supplies - Preparing study documentation and assisting the Clinical Quality Assurance Manager/regulatory authorities during audits/inspections in-house or on site - Negotiating contracts with the clinics, local/central laboratory(ies)/pharmacy etc. - Responsibility for the final archiving of all study documentation in-house - Monitoring and Oversight - communicating with study teams and sponsors - Regulatory Documentation Management - Administration - Providing status Reports to line manager - Planning budget activities for the trials - Managing timelines and deliverables for the trials - Bridget between trial site and CMC team for the supply of trial medications Skills : Education : M.Pharm or equivalent with solid clinical trial monitoring experience (6-8 years) for dermal formulations, demonstrating successful performance of Clinical Research Associate position - Experience as a CRA including all steps of the clinical study; i.e. site initiation, site monitoring and site closure - Exposure to US market filings for ANDA/NDA of Dermatology products is preferred - Should have previously worked with multiple CROs, both in India and USA - Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines - Good command of written and spoken English language - Good organizational skills, analytical and social skills - Ability to maintain effective, professional communication - Ability to prioritize and manage multiple tasks - Ability to manage and supervise study team members - Ability to handle multiple tasks with conflicting deadlines and be able to prioritize


Competencies/Skill sets for this job

Project Leader Clinical Trials Dermatology Clinical Research

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About Organisation

Konnect HR