Project Manager - Clinical Trials - Global Pharma

Clinical Trials- Project Manager- Bangalore (Global Pharma)

Responsibilities:

- Office-based position responsible for delivery of the Phase IV studies at allocated centers and is an active participant in the study team(s). Works in close collaboration with the external service provider (CRO) and the investigators to ensure that quality and quantity commitments are achieved in a timely and efficient manner.

- Initiate, conduct and deliver HA Mandated Phase IV and Real-World Evidence studies (local, regional and global) across TAs:

- External Service Provider Identification, selection, and Work in close collaboration:

- Initiate ESP contact (CRO, DM and Laboratory), exchange contracts and negotiate costs along with purchase team for DM, monitoring, central lab, translation, printing service, as applicable.

- Prepare clinical trial budget and get management approval after discussion.

- Assist in designing of study Protocol, CRF, ICF and other study related documents.

- Prepare Monitoring Plan, SDV and QC plan for the study.

- QC review of study documents, CRO and ASV along with CRO person to check QC

- Budget Preparation & approval

- Work with medical colleagues on study protocol and related documents

- Lead Investigator Meeting

- Ensure quality conduct of the study inhouse /outsourced.

- Oversee site/Investigator identification and selection, site initiation, Monitoring SDV, Close out Visits.

- Ensure Timely delivery of project from study start-up to database lock

- Ensuring compliance with the Protocol, SOPs, ICH-GCP and other applicable regulatory requirements.

- Mentoring of CRAs /CTAs

- Regular coordination and oversight to CROs to track progress of trial with target and actual milestones

- During the trial, to take CAPA to ensure GCP compliance and reliability of data

- 100% compliance with study protocol, GCP, Global and Local SOPs