Careers

Head of Clinical Operations

Reports into the CEO

Key Requirements

  1. Bachelor’s degree in scientific discipline; advanced scientific degree preferred.
  2. Minimum of 10 years in clinical research, including 3 years as head of department in a CRO or pharmaceutical company. Experience working in Oncology an advantage.
  3. Proven track record of managing multiple clinical trials/programs from start-up to publication.
  4. Proven Leadership skills.
  5. Proven experience in line management and team development.
  6. Experience in change management and process development desired.
  7. Strong working knowledge of the Irish and European Clinical Research regulatory environment,
  8. Demonstrated experience in managing budgets and contracts (operational and trial-specific)
  9. In-depth knowledge of all functions involved in the clinical trial process.

Main Function(s)

  • Lead operational strategies and plans for clinical programs and functions through appropriate leadership, direction and expertise.
  • Responsible for ensuring clinical trials are managed according to all regulatory requirements, guidelines and SOPs efficiently and within budget.
  • Line Management and guidance of the Clinical Project Management team.

Primary Responsibilities may include

    • The execution of operational strategies of the Clinical and Pharmacovigilance functions and their alignment with Cancer Trials Ireland’s mission and strategy.
    • Lead and contribute to policy development and strategic planning of Cancer Trials Ireland.
    • Build and foster strong relationships with internal and external stakeholders such as Chief Investigators, internal committees, industry partners, funders, investigator/site research team members.
    • Oversight of the operation of committees with responsibility for the scientific direction of the clinical program, the safety and medical oversight of the study portfolio.
    • Lead and present ongoing operational plans and status reports to the CEO, Clinical Executive and Board, as required.
    • Identify program risks and develop and implement mitigation strategies.
    • Recruitment, development and succession planning for staff with responsibility for study management.
    • Owner and author of SOPs relevant to study management.
    • Ensure staff are appropriately trained and comply with Cancer Trials Ireland policies, applicable SOPs and regulatory requirements and quality standards.
    • Represent Cancer Trials Ireland at national and international meetings and conferences, as required.
    • Perform other tasks as specified by the CEO.

 

Please apply directly to ide.fagan@cancertrials.ie or via the Irish jobs website here:

https://www.irishjobs.ie/Jobs/Head-of-Clinical-Operations-8531050.aspx

 

 

Trial Coordinator (TC Radiotherapy)

Reports into: Clinical Project Manager (Radiotherapy)

Key Requirements

  1. Science and/or medical or nursing background.
  2. Previous experience as Radiation Therapist or CRA. Preference given to experienced Radiation Therapists.
  3. Proven ability to deliver project goals and mentor junior level employees.

 

Main Function(s)

  • Maintain knowledge and ensure compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs (Standard Operating Procedures), study protocols and project-specific procedures.
  • Coordination of clinical trial activities for assigned studies in line with ICH-GCP, applicable regulatory/ethical requirements and guidelines, study protocols and study-specific procedures, Cancer Trials Ireland SOPs and/or other Sponsor SOPs if applicable.
  • Develop and maintain strong working relationships with external stakeholders/Sponsors.

 

Primary Responsibilities

  • Manage and coordinate assigned studies, including development of country specific documents, overseeing/performing regulatory and ethic committee applications (as applicable), and assisting Radiotherapy (RT) PM with development/set-up/operation of in-house studies in the RT portfolio.
  • Develop study protocols/ amendments and patient documents (for assigned in-house RT studies).
  • Primary contact for Sponsor and collaborator groups for assigned studies.
  • Manage project-specific training and mentoring.
  • Contribute to preparation for audits and inspections as required.
  • Evaluate and document investigator and site selection as applicable.
  • Overall responsibility for management of essential documents and Trial Master File where applicable.
  • Responsible for the completion of study initiations, monitoring and close-out as required by the study.
  • Identify issues and manage the resolution process for studies under their coordination.
  • Ensure compliance with all applicable Cancer Trials Ireland and/or other Sponsor SOPs if applicable for all studies under their coordination.
  • Input in SOP development and updates where appropriate.
  • Ensure budget agreements and contracts are in place and roles and responsibilities documented prior to commencing study activities.
  • Manage the study budget and associated financial activities for assigned studies where applicable.
  • Organise, participate in and present at meetings and discussions with other teams and team members.
  • Update Head of Clinical Operations and Project Manager where applicable for assigned studies on the status of all clinical trial activities.
  • Prepare study reports as required.
  • Perform other tasks as specified by Line Manager.

 

Please apply directly to ide.fagan@cancertrials.ie or apply here:

 

https://www.linkedin.com/jobs/view/2303317522/


Clinical Trials Administrator

Reports into the Clinical Operations Manager

Salary: 20-30K

Key Requirements

  1. Full working knowledge of and competence with Microsoft Office.
  2. Proven organisational skills.
  3. Working knowledge of clinical trial process an advantage.
  4. Science or nursing qualification

Main Function(s)

  • To carry out administrative duties on assigned studies in line with ICH-GCP, applicable regulatory requirements and guidelines, SOPs, study protocols and study-specific procedures.
  • To provide additional administrative support to Clinical Operations Department and office where required.

Primary Responsibilities may include

  • Preparation of Trial Master Files and Investigator Site and Pharmacy Files, including printing, filing, and tracking of clinical trial documents.
  • Serving as administrator of the Trial Master File with direction from Project Management, including the preparation, maintenance, and archiving of the TMF.
  • Coordinate the preparation, collection, tracking and filing of essential documents including centralised documents (Investigator/ investigational site staff CVs, Investigator Agreements, GCP certificates, laboratory accreditation, etc.)
  • Preparation of site-specific study documents, including patient related documents under the guidance of the Clinical study team.
  • Collating and sending clinical trial documents to hospital sites and Sponsor. Ordering and tracking of clinical trial supplies and investigational product.
  • Assist in the logistics for bio-sample shipments.
  • Processing study subject registrations for Cancer Trials Ireland studies.
  • Responsible for main reception phone, stationary supply and other office tasks as part of the office administration team.
  • Coordinate queries and direct issues to appropriate clinical research personnel.
  • Assist Data Management with collation and tracking of Case Report Forms (CRFs), including generation of specific Data Management reports.
  • Organise meetings, prepare agendas and minutes.
  • Assist with training administration and preparations for training courses.
  • Handle Cancer Trials Ireland membership requests; assist in update and maintenance of Cancer Trials Ireland membership details.
  • Input into SOP development where appropriate.
  • Contribute to preparation for audits and inspections as required.
  • Perform other tasks as assigned.

Skills:

Good clinical practices, Science degree, Organisational Skills, Microsoft, Excel

 

Please apply directly to ide.fagan@cancertrials.ie or via the Irish jobs website here:

https://www.irishjobs.ie/apply