Clinical Project Manager

IQVIA Holdings Inc.; Reading; On-site; GBP 55,000 - 76,000; Full time

Job summary

IQVIA Holdings Inc. is seeking a Clinical Project Manager to lead study commitments at the country level in Reading, UK.

You will oversee a Local Study Team of CRAs and CSAs, ensure quality data delivery, and manage regulatory submissions with EC/IRB and authorities. You will coordinate site selection, feasibility assessments, and budgets, while maintaining country-level master documentation and CTMS setup.

Qualifications

• Bachelor degree in life sciences or related field.
• Minimum 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, budget and quality.
• Excellent spoken and written English.

Responsibilities

• Oversee country study commitments and timely data delivery to required quality.
• Lead Local Study Team (CRA/CSA) for assigned studies.
• Coordinate site selection, site risk assessment and site qualification visits.
• Ensure timely regulatory submissions to EC/IRB and regulatory authorities.
• Prepare country Master CSA and MICF and translations.
• Set up CTMS and local websites as required by local laws.
• Oversee monitoring activities from site activation to study closure.
• Identify risks and resolve complex study issues.
• Organise regular Local Study Team meetings.
• Travel nationally and internationally as required.

Skills

Leadership

Cross-functional teamwork

Project management

Negotiation

Attention to detail

English language

IT systems

Travel

Education

Bachelor's degree in life science or related field

Tools

CTMS

Clinical financial system

Job description

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CSA(s), for assigned studies.
• Leads the performance of the Local Study Team at country level ensuring compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.
• Ensures that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, including any relevant translations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports (as required and following Sponsor SOPs) and pro-actively advices the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organises regular Local Study Team meetings on an agenda driven basis.
• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• At least a year of experience in Clinical Project Management at Local level.
• Very good knowledge of Oncology or Respiratory therapeutic area.
• Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality., Strong ability to prioritize and handle multiple tasks, attention to details and negotiation skills.
• Very good knowledge of spoken and written English language.
• Good ability to learn and to adapt to work with IT systems.
• Ability to travel nationally and internationally as required.
• IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
• IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.