Clinical Project Manager

2 weeks ago

Cebu City, Central Visayas, Philippines Kaptan Talent Solutions, Inc. Full time

Project Manager (Clinical Studies)

Role Purpose

The Project Manager oversees the planning, execution, and monitoring of clinical studies. The role ensures that projects are delivered on time, within budget, and in accordance with the procedures, Good Clinical Practice (GCP), and regulatory requirements. You will work closely with physicians, labs, and internal teams to ensure smooth study operations and strong client satisfaction.

Key Responsibilities

1. Study Planning & Startup

  • Review Statements of Work (SOW) to ensure feasibility, timelines, and budget alignment.
  • Recommend investigational sites and support site qualification processes.
  • Develop detailed project plans covering sites, logistics, CTMS/Salesforce setup, kits, shipping, and risk mitigation.
  • Design study protocols and CRFs/eCRFs that capture required data and minimize errors.
  • Work with kit-making, lab, PI/CSO, and site network teams to finalize all study setup components.
  • Ensure IRB submissions and regulatory documents are completed on time.
  • Train site staff and internal teams as needed.

2. Study Oversight & Execution

  • Monitor study progress, risks, and issues; communicate proactively with clients.
  • Respond to client emails and requests within expected turnaround times.
  • Lead or attend client calls and provide timely meeting minutes.
  • Oversee monitoring activities, CRF reviews, protocol compliance, AE documentation, and quality checks.
  • Ensure sites have required supplies, documents, and support.

3. Study Closeout & Reporting

  • Prepare for and host monitoring visits, client audits, and inspections.
  • Maintain accurate regulatory binders and study documents.
  • Review and approve site payments and ensure client invoicing is done promptly.
  • Oversee data management activities, including CRF finalization, file generation, and data QC.
  • Coordinate sample shipments and review manifests.

4. Project & Operational Management

  • Set weekly priorities and ensure alignment across internal and external teams.
  • Recommend resource adjustments to balance workload and enable new studies.
  • Identify process gaps and suggest improvements to the Clinical Studies workflow.
  • Build and maintain strong relationships with clients, physicians, labs, and partners.
  • Prepare bi-weekly project updates and ensure repeat client business.
  • Train junior staff and ensure consistency in sample collection across sites.

Core Competencies

  • Strong organizational and project management skills
  • Excellent communication and client-facing skills
  • Ability to manage risk, timelines, and complex logistics
  • Knowledge of clinical operations, IRB processes, and GCP
  • Detail-oriented with strong problem-solving abilities
  • Ability to work cross-functionally with physicians, labs, and internal teams

Not a Managerial Role

This role does not yet include direct managerial or Manager-once-removed (MoR) responsibilities, but it requires coordinating and receiving services from multiple teams.

Job Types: Full-time, Permanent

Benefits:

  • Additional leave
  • Health insurance

Application Question(s):

  • Are you willing to work onsite in Cebu IT Park on a nightshift?

Work Location: In person

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