Role & responsibilities

Cordination, review and finalization of product feasibility reports and Study Initiation

- Coordinate with the Business Development (BD), Managements Representative (MR), Head, Clinical Pharmacology, Investigator(s), Head - Project Management, Bioanalytical Research Personnel (BRD) and Biostatistician regarding feasibility of study proposals and study initiation.

Review and finalization of Study documents
- Coordinate with the Principal Investigator (PI)/ Clinical Investigator (CI), Medical Writers (MW) Project Coordinator (PC), Biostatistician, BRD personnel, Clinical Quality Monitor (CQM), Quality Assurance (QA) and Sponsor for preparation/ review of the protocol and other essential documents e.g. Informed Consent Documents (ICD), Case Report Form (CRF) and working document.

Study Planning and Execution
- Coordinate with designated person from clinical research department to ensure timely submission of study related documents to Ethics Committee and approval.
- To ensure the approval of EC well in advance prior to initiation of the study.
- Coordinate with Investigator for intimating the EC for the study progress.
- Coordinate with regulatory department and ensure the submission of all the study documents to the Regulatory Agency (DCGI or any other) if NOC is required
- Coordinate with regulatory department for following regulatory clearance well in advance prior to initiation of the study, if essential.
- NOC from DCGI for study conduct
- T-license for import of Investigational products
- NOC from Narcotic department in case of controlled substances
- Any other as per requirements
- Cordination, review and finalization of product feasibility reports and Study Initiationnnel and Biostatistician.
- Coordinate with the PI/ CI, MW, PC and/ or CQM for planning and execution of clinical phase of study.
- Coordinate with Head BR and/or concern BRD personnel for bioanalytical phase of study.




- Execute the study as per the define timeline suggested by client and operational teams.
- Coordinate with Head QA and/ or concern Auditor for audit and review of study phases/documents.
- Coordinate with Head Biostatistician and/ or Concern person for statistical phase of study.
- Coordinate with concern department for resolution of study/ system related queries, from the sponsor/ regulatory.

Sponsor Communication Communicate with the sponsors representative for followings:
- Arrangement of pre-study initiation meeting, if necessary.
- Provide study related update (schedule timeline, dosing progress, report to sponsor on regular basis (at least weekly)
- Teleconference with each sponsor at least quarterly basis and report to management
- Resolve project related issues, e.g. Investigational products, recruitment, dosing, safety reporting, report compilation etc, if any.
- Accompany the sponsors monitor during his/ her visit for monitoring/ audit, if necessary.
- Coordinate with Data Management (DM) team for submission of CRFs and/or other essential documents, and resolve all the data queries.

Regulatory/Client Audit or Visit
- Coordinate with PI/ CI, PC & CQM, and ensure the availability of all the study documents as per the TMF checklist for audit.
- Assist Head- Project Management during client/regulatory audit.
- Responding Regulatory/ Sponsor audit reports 5-7 days before decided timeline.

Biopharmaceutics development
- Evaluate the in-vivo & in-vitro data based on PK & IVIVC
- Understanding the Biopharmaceutics and IVIVC




- Develop and practice IVIVC for in-house data
- Apply BCS classification in data evaluation and design of the study. Investigate the clinical study outcomes by pharmacokinetics, biopharmaceutical, in vitro dissolution data assessment, and PK modeling & simulations to find out the scientific reasons related to BE failures further discuss on the developmental strategies.
- Identify the potential molecules for bio-waiver strategies/ bridging of clinical studies, based on their BCS class & other scientific and regulatory assessments.
- Preparing team for Current Business Services
- Biosimilars: Understanding of regulatory requirements for study design, data evaluation and conclusion for patient based PK/ PD/ clinical end point study.
- Inhalation Studies: Understanding of regulatory requirements for study design, data evaluation and conclusion for patient based PK/ PD/ clinical end point study
- Derma patches Studies: Understanding of regulatory requirements for study design, data evaluation and conclusion for patient based PK/ PD/ clinical end point study.
- Others
- Preparation of Non clinical overview (2.4) and clinical overview (2.5) documents as per regulatory requirement.
- Ensure that Protocol/ SOP deviations, File notes are appropriately documented
- Coordinate with Report writer, PC, PI/ CI, Biostatistician, BRD personnel, QA for final report preparation and compilation.
- Coordinate with Head - Project Management for preparing new SOP as well as revising current SOP to upgrade the system.
- Perform any other duties as assigned by Head - Project Management.
- Bioavailiability Bioequivalence concepts
- Technical documents & regulatory knowledge
- Project planning and Execution
- Project Stakeholder & Sponsor Communication
- Escalation and Risk Management
- Clear the concept of PK/STAT
- Manage deviations/issues

📌 Project Manager (Ahmedabad)
🏢 Veeda CR
📍 Ahmedabad