Pharma Job : Protocol Writer Position Vacant @ Lambda Therapeutic Research

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Lambda Therapeutic Research
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA.
Job Title  Protocol Writer

No. of Posts 3

Experience : 2 – 7 Years

Location : Ahmedabad(Gota)

Job Description:

Feasibility

  • To conduct the feasibility for the late phase Clinical trials as per the requirements of the sponsor.

Medical Writing

  • Prepare and review study related documents like Protocol Synopsis, Study Protocols, Investigators Brochure,
  • Informed consent forms, Clinical study reports, Patient diaries, Case Record Form etc.
  • Liaises with the study team, Sponsor and the key opinion leaders in therapeutic areas to finalise the study related documents.

Training

  • Train the study team members of the study protocols and other study related documents.
  • Train the members of the department on the various therapeutic / technical areas

Pharmacovigilance

  • To ensure that safety information received from the site/sponsor is processed consistently, accurately, in a timely manner and in compliance with GCP/protocol/agreed SOPs /Schedule Y and reported to DCGI and appropriate personnel.
  • To Liaise with the study team and the site personnel to get additional information and documents.

General Duties

  • Keep abreast with the development in the field of clinical research in India and overseas.
  • Comply with quality initiatives designed by the department.

Qualifications

Education:
  • UG -B.Pharma – Pharmacy, MBBS – Medicine
  • PG – M.Pharma – Pharmacy, Medical-MS/MD – Any Specialization, PG Diploma – Any Specialization

Apply Online

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