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Medical Monitor Bengaluru India,  

Navitas Life Sciences (company)


Posted on : 22 December 2017

Project Description

Category: Experienced (non-manager)
Location: Bangalore
Job Type:
Full Time
Education: Graduation / Post Graduation in Medical

Job Description:


Responsibilities & functions:

  • In depth knowledge of and experience as a medical monitor for clinical trials (Phase I - III)
  • Experience managing projects in a matrix environment, coordinating activities and adhering to tight timelines
  • Attend meeting with sponsor s medical team along with PM, DM, stats as required
  • Providing continual medical and scientific inputs during the conduct of the study for handling clinical trial related issues
  • Review of patient eligibility
  • Review and assessment of protocol deviation
  • Medical review of clinical trial data and trend analysis (including laboratory data, adverse events, physical examination findings, concomitant medications, vital signs, adherence to protocol procedures etc.)
  • Plan, facilitate and lead the global multidisciplinary Clinical Trial team
  • Provide direct operational input into protocol development to ensure efficient and effective delivery of trial objectives
  • Communicate protocol information including changes or amendments to countries
  • Review of SAE s for completeness, correctness of information and causality assessment and medical inputs to site
  • Preparation and Review of Safety Narratives/Patient Narratives
  • Review of Post Marketing Experience Safety Report
  • Preparation of DSUR s/Aggregate safety reports
  • Preparation and review of medical monitoring manual for clinical trials
  • AE and SAE reconciliation for clinical trials
  • Investigator training for on the protocol, reporting adverse events/serious adverse events and handling safety data in clinical trials through Investigator meeting
  • Responsible for ensuring compliance with Good Clinical Practices, Good Pharmacovigilance practices and applicable national and international regulatory guidelines for the conduct of Phase II, III and IV clinical studies
  • Present study updates as needed
  • CSR writing (review final TLFs, work with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings)
  • Topline results presentation
  • Other tasks may be required as determined during the project by client

Preferred Skills:


  • Medical degree
  • Common medical practices in various therapeutic areas preferably oncology, biosimilar etc.
  • Good verbal and written communication skills essential
  • Proficiency in literature search of databases
  • Presentation skills
  • Knowledge of ICH/GCP
  • Knowledge of Regulatory guidelines - India, USFDA, EMEA etc.
  • Microsoft Office- Word, Excel, Power point
  • Electronic data capture systems - Oracle Clinical RDC
  • Soft skills (motivation, strong communication competence, structured in work, organising skills, reliability, commitment and capacity for team-work)
If you would like to apply for this position, or would like a discussion about this, or any other role, please send your contact details, together with your curriculum vitae to: recruitment.bangalore@navitaslifesciences.com

Locations

Bangalore India

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