Senior Medical Writer- Clinical Research

1 week ago

Hyderabad, Telangana, India Vimta Labs Full time ₹ 6,00,000 - ₹ 15,00,000 per year

Senior Medical Writer - Clinical Research (BA / BE Studies) @ Vimta Labs Ltd, Hyderabad

Experience: 8-12 years in Medical writing field in Clinical Research BA/BE studies

CTC : As per market standards

Report to: Principal Investigator Clinical

Primary Responsibilities:

  1. Ensures that Good Clinical Practices (GCP) and NDCT (New Drugs and Clinical Trials Rules) are followed.

  2. Writing and developing BA/BE and clinical trail protocols.

  3. To perform literature search and preparation of feasibility.

  4. Preparation of study specific informed consent forms (ICFs), case report forms (CRFs) and blood sample forms.

  5. Preparation of clinical study reports (CSRs), DBE/summary tables, CS-BE tables and module

2.7.1 (M and other required documents in compliance with applicable regulatory guidelines.

  1. Co-coordinating departmental activities to ensure timely delivery of the final reports with quality.

  2. Co-coordinating and liaising with operational team (internal & external) as necessary.

  3. Collection of demographics, AEs, SAEs, subject disposition, protocol deviations, dosing information from CRFs and TMFs, that are required for the preparation of CSR.

  4. Narration of SAEs.

  5. Preparation of eCRF (creation of forms, study registration and other required fields) before study execution.

  6. Monitoring team for achieving TAT.

Secondary Responsibilities

  1. Review of Tables and listings (TLs)

  2. Ensures that Case Report Forms (CRF) are reviewed in a timely manner and submitted for further process.

Interested candidates can share their resumes to

Contact:

Keerthana

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