Clinical Project Manager

Berkshire Source: WhatJobs

See advert for pay

Overview

In this role you lead Local Study Teams at country level to deliver study commitments on time and with quality, aligning with Sponsor procedures and ICH-GCP. You will oversee site identification, qualification, setup, monitoring and documentation, while collaborating with Regulatory Affairs, CROs and cross-functional partners. The position involves local regulatory submissions, budgeting, and CTMS setup, with potential site monitoring to support a flexible capacity model. You drive risk management and ensure compliant execution of country-level trials.

Responsibilities

Own country-level study commitments and timeliness of data delivery
Lead Local Study Team (CRA/CSA) for assigned studies
Ensure compliance with Sponsor procedures, ICH-GCP and local regs
Coordinate site selection, Site Quality Risk Assessments and Site Qualification Visits
Oversee regulatory submissions to EC/IRB and Regulatory Authorities during the study
Prepare and maintain country-level budgets and Master CSA and MICF
Prepare country-level MICF and site ICFs, including translations
Ensure collection of essential ICH-GCP documents prior to study start
Plan local drug activities (purchasing, reimbursement, destruction)
Set up and maintain study in CTMS and local websites
Oversee monitoring activities from activation to study closure
Review monitoring visit reports and advise monitors on issues
Co-monitoring and accompanied visits with CRAs
Identify risks and drive resolution of complex study problems
Organise regular Local Study Team meetings

Key requirements

Bachelor degree in related discipline, preferably life science
At least 1 year of local Clinical Project Management experience
Strong knowledge of Oncology or Respiratory therapeutic areas
Proven ability to lead cross-functional teams to deliver trials on time, within budget and with quality
Clinical Trial Phase III experience
Excellent understanding of Clinical Study Process including monitoring
Excellent project management skills
Strong ability to prioritize, multitask, detail-oriented, and negotiate
Proficiency in English (speaking and writing)
Ability to learn and adapt to IT systems
Ability to travel nationally and internationally
Location restrictions: candidates must be based in listed location(s); UK visa sponsorship not available