Role & responsibilities

Preparation of Study documents

- Co-ordinate with the Project Manager (PM), Principal Investigator (PI) and/or Clinical Investigator (CI), Bioanalytical team, and Statistician, for protocol preparation
- To prepare documents for complex studies (e.g. phase I, steady state, injections, inhalations, patch, gel, complex design (like biosimilar study, food effect, dose proportionality, drug-drug interaction, two-stage design) etc.)

- To prepare informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and its back translation into English, if applicable.

- To Prepare of the CRFs and other working documents, if applicable.

- To prepare documents for submission to the regulatory.

- Incorporate the protocol comments received from Investigator, QC,

- QA, BR and Sponsor before finalization of the same.

- Internal QC of study documents

- Literature Search
- To prepare departmental SOP and review cross-functional SOPs for their impact, preparation of project based check-list and ensure compliance by team.

- Effectively plan, prioritize,



and manage multiple protocols to ensure timely completion within agreed timelines.

Feasibility of the study proposal

- To assist Project Manager for feasibility assessment of study proposal.

- Literature survey for PK & Safety study

IEC Communication

- Co-ordination with Principal Investigator (PI) and/or Clinical Investigator (CI) for application.

- To prepare documents for submission to the Ethics Committee (EC).

- Any other task given by reporting authority.

MIS

- Help to maintain the Audit tracker.

Team development & Team management

- Support and help resolve inter and intra-departmental issues for achieving organizational objectives.

- Responsible to manager departmental work in the absence of the reporting manager.

- Responsible for team development by mentoring and training.

- Any other task assigned by reporting authority.

- Involvement in training to current joiners.

- To review of the study documents prepared by the team.

📌 Medical Writer - BA/BE Studies (Ahmedabad)
🏢 Veeda CR
📍 Ahmedabad