Clinical Trials Project Manager

Royal College of Surgeons in Ireland (RCSI); Dublin; On-site; EUR 32,000 - 52,000; Part time

Job summary

Royal College of Surgeons in Ireland (RCSI) is seeking a part-time Clinical Trials Project Manager to support two cardiovascular trials (CYCLOPES/DUBSTENT and STREAMLINE) within CVRI Dublin. The role involves coordinating sites, budgets, regulatory filings, and sponsor communications to ensure timely trial delivery.

The position is based at Granary House, Dublin City Centre, with close collaboration across RCSI, CVRI Dublin, and Mater Private Hospital Dublin.

Qualifications

• Bachelor’s degree in life sciences, medicine, nursing, pharmacy, or related field.
• Significant experience coordinating clinical trials and managing sponsor relationships.
• Familiarity with regulatory submissions and ethics approvals.

Responsibilities

• Support clinical trial planning, budgeting, and feasibility.
• Coordinate site activation, monitoring visits, and data management.
• Aid sponsor with contracts, regulatory filings, and sponsor communications.

Skills

Project management

Stakeholder liaison

Regulatory knowledge

Study Monitoring

Education

Bachelor’s degree in life sciences, medicine, nursing, pharmacy, or related field

Tools

EDC systems

CTMS

Job description

ob Title: Clinical Trials Project Manager x 2

Department: Cardio Vascular Research Institute (CVRI) Dublin

Reporting to: Director, CVRI Dublin

Location: Granary House, Dublin City Centre

Contract/Duration: Part-time (0.8 FTE/4 days week), Specified purpose contract

CYCLOPES/DUBSTENT Project: Up to 2 years

STREAMLINE Project: Up to 3 years

Closing Date: Wednesday, 16th of September

Role Overview

The Clinical Trials Project Manager will support the planning, set-up, execution of cardiovascular clinical trials conducted through CVRI Dublin. The Clinical Trials Project Manager will also support RCSI Sponsorship Office in fulfilling oversight responsibilities for academic trials led by CVRI Dublin.

There are two Clinical Trials Project Manager roles available. One role will support the STREAMLINE project, and one the CYCLOPES/DUBSTENT project.

CYCLOPES/DUBSTENT Project

Based at the Cardiovascular Research Institute (CVRI) Dublin, Mater Private Hospital Dublin, and RCSI in Dublin. This part-time role will support the successful delivery of two innovative Investigator led, cardiovascular research studies: CYCLOPES (Multinational IVUS-guided calcium modification study) & DUBSTENT DIABETES (National randomised Medical Device Study). The postholder will coordinate these ongoing studies (across the Irish participating sites) for both programmes working closely with the Principal Investigator, executive director of CVRI, Sponsor - RCSI, recruiting sites and external stakeholders.

The STREAMLINE Project

Based at the Cardiovascular Research Institute (CVRI) Dublin, Mater Private Hospital Dublin, and RCSI in Dublin. This part-time role will support the ongoing delivery of STREAMLINE, an investigator-initiated pragmatic, multinational, randomised, open label cardiovascular clinical trial. The postholder will coordinate activities across participating Irish sites, liaising closely with the Principal Investigator, Executive Director of CVRI, RCSI as Sponsor, recruiting centres, and external stakeholders.

Key Responsibilities

Clinical Trial Planning

• Support cost assessment and financial planning
• Engage with RCSI pre-award team for the submission of funding applications
• Engagement with sites for feasibility assessments

Clinical Trial Management

• Support financial management of clinical trials. This includes:
• Liaise with RCSI Post-award Officer for grant registrations and amendments
• Monitor budgets, cash flow and payments
• Liaise with RCSI Finance Department to:

• (a) initiate payments request, internal payments and payments to third parties.
• (b) support the preparation of financial reports
• (c) process requisitions, purchase orders and invoicesMonitor expenditure on RCSI reports of CVRI Dublin clinical trials' research accounts

• Monitor clinical trial deliverables and milestones and proactively ensure that clinical trial activities are delivered by CVRI Dublin, RCSI Sponsorship Office, Clinical Research Organisations (CROs) (where applicable) and other clinical sites in a timely manner.
• Manage change orders with CROs or funders
• Prepare weekly clinical trial updates for CVRI Dublin and RCSI Sponsorship office
• Be CVRI Dublin point of contact for clinical sites to support sites’ set up and conduct activities.
• Support RCSI legal team in engaging with sites for contract negotiation and amendments
• Monitor CROs’ performance and liaise with CROs in relation to reports, contracts, meetings, payments, correspondence with CVRI and RCSI Sponsorship Office,
• Support the preparation and submission of reports to funders
• Management of CVRI Dublin meetings with funders, RCSI Sponsorship Office, and Investigators

Sponsorship Activities

Support RCSI Sponsorship Office with

• Ensuring studies are registered and updated on appropriate clinical trial registries (e.g. clinicaltrials.gov)
• Planning and management of DSMB meetings, in conjunction with the Sponsor
• Development of Clinical Events Committee (CEC) and CEC Charter
• Liaison with international Sponsors
• Coordination of investigators meeting & newsletters
• Preparing NREC submission packages for initial applications & substantial modifications (package to be approved and Quality Controlled (QC’d) by Quality & Regulatory Affairs Manager QRAM)
• Coordinating and supporting PIs with contracts between RCSI and hospital
• Assisting Sponsor with Greenlight (collection of all relevant documents).
• Tracking site activation timelines
• Procurement of devices and managing communication with site
• Day-to-day Trial Master File (TMF) maintenance and filing
• Assist site with Investigator Site File (ISF) preparation and maintenance
• Provision of training for site staff (during study)
• Coordinating site initiation visits (SIVs) and refresher site initiation visits (as needed)
• Coordinating and arrangement of monitoring visits at all sites
• Tracking monitoring reports and follow-up letters from sponsor monitor
• Following up on open issues/queries
• Become point of contact for sites for all issues/ maintaining investigator/site communication, including
• Managing and coordinating data (electronic data capture systems)

Study Monitoring Responsibilities

• Review and / or develop, and implement study monitoring plans proportionate to the complexity and risk profile of clinical studies in conjunction with sponsor representative.
• Conduct and document routine monitoring activities, including site initiation, routine monitoring, and close-out visits, in accordance with the trial monitoring plan, protocol, ICH-GCP, sponsor requirements, and applicable regulatory standards.
• Review source documentation, trial master files, investigator site files, and study records to ensure participant safety, data quality, protocol compliance, and regulatory adherence.
• Identify, document, and follow up on protocol deviations, findings, and corrective and preventive actions (CAPAs) to ensure timely resolution of issues.
• Monitor study conduct across participating sites to ensure compliance with approved protocols, informed consent requirements, ethics approvals, and relevant legislation.
• Provide guidance and support to investigators, research nurses, study coordinators, and site staff on protocol implementation and Good Clinical Practice requirements.
• Prepare monitoring reports and communicate findings, risks, and recommendations to study teams and sponsors in a timely manner.
• Escalate significant quality, compliance, safety, or operational issues to the Principal Investigator, Sponsor Representative, or relevant governance committees as appropriate.
• Contribute to risk assessments, quality management activities, audit preparation, and inspection readiness across the study portfolio.
• Maintain oversight of study performance, recruitment, data quality, and regulatory compliance through centralised and on-site monitoring activities.

Data & ECRF Management

• Support CVRI Dublin in the setting up / user acceptance testing of electronic case report forms
• Work with CVRI Dublin Precise Core Lab to ensure core lab protocols are in place, image transfer systems are activated and sites are compliant in sharing data

Trial close out

• Support CVRI Dublin and the Sponsorship Office in the preparation of final reports to ethics and regulatory bodies

Experience

• Significant experience in clinical trial co-ordination and management, with a proven track record of successful delivery.
• Demonstrated experience in:
• Managing trials from start-up through close-out
• Regulatory & Ethics submissions and approvals
• Study Monitoring
• Budget and project management
• Working with sponsors and/or grant-funded research environments

Technical Knowledge

Strong knowledge of

• ICH-GCP
• EU Clinical Trials Regulation (CTR)
• Medical Device Regulation (MDR)
• Ethics and regulatory processes (HPRA, REC) in Ireland & Europe

Understanding of

• Investigator Initiated Grant (IIG) frameworks
• Contracting processes (CTAs, site agreements)

Skills

• Strong project and programme management capability
• Excellent stakeholder and cross-institutional liaison skills
• Experience working with academic, regulatory, and industry partners
• High attention to detail and governance standards

Experience in

• Multicentre or international cardiovascular trials
• Medical device, pharma and clinical strategy trials.
• Academic or university-led trials
• Grant application processes (pre- and post-award)

Familiarity with

• Registry-based or EHR-enabled trials
• Electronic Data Capture and clinical data platforms

Educational Qualifications

• Bachelor’s degree in life sciences, medicine, nursing, pharmacy, or related field
• Clinical Research
• Public Health
• Regulatory Affairs
• Cardiovascular Science (advantageous)

Certifications

• ACRP / SoCRA certification
• PRINCE2 / PMP (project management)

We are all too aware that imposter syndrome and the confidence gap can sometimes stop fantastic candidates putting themselves forward, so please do submit an application we’d love to hear from you.