Clinical Research Project Manager

Metropolis Healthcare Limited; Hinoba-an; On-site; PHP 420,000 - 620,000; Full time

Job summary

Metropolis Healthcare Limited is seeking a QA support professional to assist during client and study audits and ensure updated documentation is ready for review. The role emphasizes training recruits on SOPs, Metro lab processes, and organizational functions to enable seamless project execution.

The position focuses on upskilling team members on system advancements, conducting governance calls with clients, and contributing to revenue growth through innovation, while maintaining strict

Qualifications

• Experience supporting QA during client and study audits.
• Ability to ensure updated documentation is ready for review.
• Experience in training and induction on SOPs and lab processes.

Responsibilities

• Set up and manage project activities after study award, review protocol versus quote, document clarifications.
• Coordinate with sponsor and Investigators Meeting organizers.
• Assign Project Executive for setup and management; train study team on protocol.
• Coordinate data transfer setup with IT; attend SIV or provide telephonic training to site team.
• Review study documents, customize CRF/LIM, and ensure timely client code/logistics setup for sample receipt.
• Monitor reports and communicate important results to clients; manage complaints and CAPA where needed.
• Oversee project close-out, archival of documents, and QC checks prior to data lock.

Skills

QA audits

Documentation

Training

SOPs

MIS reports

Cross-functional collaboration

Automation

Compliance

Tools

LIMS

Job description

The role involves supporting QA teams during client and study audits by ensuring

all updated documentation is readily available for review, while also driving training

and induction initiatives for new recruits on SOPs, Metro lab processes, and

organizational functions to enable seamless project execution. It includes upskilling

team members on system advancements, conducting regular governance calls with

clients, and contributing to revenue growth through innovation.

The position further ensures strong cross-functional collaboration between

technical and non-technical lab teams, effective complaint management with a

focus on automation, strict adherence to compliance, SOPs, and quality guidelines,

and thorough review and monitoring of MIS reports to drive operational efficiency

and performance

What the role entails – Key accountabilities/ responsibilities

Project Set Up:

• Initiate project Set up activities after the study award to Metropolis. Reviewing protocolvis a vis the quote and seeking clarifications from the sponsor wherever essential anddocumenting the same.
• Participating in the Investigators Meeting organized by the sponsor.
• Assigning a Project Executive for the set up and project management activities
• Training the study team on the protocol.
• Initiating project set up activities.
• Coordinating with the IT team for the data transfer set up, if applicable for the study.
• Attending the SIV if requested by the sponsor or imparting telephonic training to the siteteam.
• Supervising the projects team in the set up activities including reviewing of studydocument but not limited to; Customizing the TRF, LIM, Test Profiles, dummy reports forthe parameters to be analyzed at Metropolis
• Request for Client codes, Logistics set up for the timely receipt of specimens atMetropolis, Mumbai and ensuring that the project set up is complete prior to FPFV.

Project Management:

• To monitor that the team released the report of the specimens received at Metropolis within the committed TATS.
• To monitor that the Call alerts, Test Not performed or any other result deemed important be conveyed to the Client/ Patients and the same be documented.
• Review all Problem data, Problem specimens are conveyed to the Patients/Clients and
• maintain documentation and follow up for the same.
• Monitoring whether study team is maintaining necessary specimen status, kit inventory and the same is updated in a timely manner.
• Resolving any queries from sponsor or Investigator site. In case of technical queriesrelated to any parameter results the Team Lead-CR would co-ordinate with the relevantlaboratory personnel and forwards the same to the sponsor/site.
• Participate in telecons to update the sponsor of the study progress.
• Checking /QC the Electronic data file to ensure that a clean error free data file istransmitted to the sponsor
• In case of any Complaints/Grievances received from the Clients, QA team would beimmediately notified of the same and CAPA or Note to File generated and shared withthe Client
• Monitoring overall activities of the team to ensure that the study is managed as per theSOP's and any guidelines laid down by the sponsor

Project Close Out:

• Monitoring that all the reports are released, Problem data and Problem specimen resolved prior to data lock and perform QC checks of documents prior to Archival
• Performing QC of all the documents prior to the Archival of the documents
• Monitoring that all study related documents are Archived appropriately with the
• necessary documentation following project close out

What we are looking for in you

Project Set up and Management Activities for Clinical Trials,