Clinical Projects Manager

Reports To: Chief Medical Officer

Main Roles & Responsibilities

Reporting to the CMO, and working closely with colleagues in the medical team and across Carrick Therapeutics, this role will require best-in-class clinical project management skills and relevant expertise. You will play a pivotal role in supporting programme design, delivering pre-trial, on-trial and post-trial project management to ensure the smooth, effective and transparent execution of Clinical Projects across the Carrick Therapeutics portfolio. For each programme you will be responsible for the following:

  • Pre-trial project management: Ensure comprehensive preparation for each clinical project, including:
    • Investigational Drug Brochure: Drafting the IDB for trial investigators and regulatory purposes, to include current and accurate summaries of what is known about the drug under investigation
    • Trial Protocol: Participating in trial protocol discussions: working with laboratory scientists, clinicians, regulatory affairs professionals, statisticians and others, to ensure that all necessary design requirements are addressed
    • Site selection: Ensuring that investigational sites have the required infrastructure, equipment, expertise, and trained/qualified staff to conduct the clinical trial
    • Approvals: Ensuring all documents to protect patients are in place before any is exposed to the investigational drug
    • Data Management: Ensuring that the data management plan has been appropriately discussed and approved, and includes the schedule for patient stratification & randomisation, CRF design and plans for data monitoring
    • Laboratory handling of samples: Ensuring that any specific requirements e.g. for handling tissue biopsies or biomarkers are included in the study protocol and that these have been explained fully to operational staff before the trial commences
    • Trial Supplies: Ensuring that all investigational drugs and other trial materials are properly labelled and delivered on time and to the correct locations together with the schedule for patient randomisation
    • Presentation: Visiting the investigational sites (with CRO/SMO partners), before any patient is entered, to ensure the trial objectives and key requirements are well explained and understood
  • On-trial project management: Ensure smooth, effective and transparent progress including:
    • Site monitoring: Monitoring patient progress either directly or through project management of the sub-contracted organisation. Ensuring that investigational sites are operating in full compliance with the tenets of Good Clinical Practice, including Carrick’s Clinical SOPs; that the conduct of the trial is specifically in compliance with the approved trial protocol and any on trial protocol/amendment(s); and that the reported trial data are accurate, complete and verifiable from source documents
    • Patient Safety: Monitoring and evaluating all safety and efficacy information to the extent possible as it becomes available
    • Adverse Event monitoring: As a priority, monitoring events arising that might indicate a risk to patient safety. This includes symptoms (expected and unexpected) reported by patients, their attending clinical team or abnormal laboratory findings. Organising timely updates on patient status to be forwarded to the clinical trial physician assigned by Carrick to ensure patient safety and copied to personnel responsible for regulatory affairs
    • Supplies: Ensuring the investigational study sites remain well stocked with trial supplies and monitoring the inventory of usage
    • Data Base: Updating the IDB as new data emerges
  • Post-trial project management: At the end of the Study:
    • Overseeing the close-down of the investigational sites, retaining the patient randomisation schedule and codes, the drugs inventory, any unused trial supplies and any outstanding CRFs
    • Assisting medically-qualified colleagues in drafting the Clinical Trial Report
  • General professional accountabilities: Throughout all activities, you will:
    • Maintain knowledge of current developments in oncology, particularly in regard to tumour resistance. Become full conversant with the science underlying Carrick’s drug assets
    • Uphold the highest professional standards of integrity and confidentiality in representing Carrick to all external parties, particularly oncologists and their support staff, research partners, contract research organisations and – where appropriate – patients
    • Be a collaborative member of, and effective contributor to the internal project teams at Carrick, and extend the same behaviours to team interaction with the Company’s research and development partners
    • Assist in the development of Carrick’s Standard Operating Procedures (SOPs), taking the lead in drafting those SOPs directly connected with clinical investigations

Position Requirements

Candidates should have a profile that is closely aligned to the following:

  • Degree in the life sciences
  • A higher qualification (Master’s degree or PhD) is not essential but would be advantageous
  • A minimum of 5 years’ hands-on experience working in clinical project management in accordance with EU/International Guidelines on Good Clinical Practice, either in a major pharmaceutical or contact research organisation
  • Previous experience of working in oncology and/or oncology trials
  • A positive, constructive and team-oriented work style, able to operate through influence and effective communication, and able to engage others around common goals
  • Well organised, self-motivated and able to work with minimal supervision
  • High energy, commitment and willingness to align to the values of the business

To express interest in this position please send your current CV & Contact details here. Your application will be treated in strict confidence.

  • This field is for validation purposes and should be left unchanged.

Notice to Search Organisations:
At Carrick Therapeutics, we strive for the highest standards in handling applications and observance of equal opportunities. We do not accept unsolicited CVs sent by third parties and are under no obligation to either respond or react to them. If someone is interested in our company and what we have to offer, we advise them to contact us through the appropriate channels given above.