Clinical Data Manager

Location
Dublin (Hybrid model)
Contract Type
Permanent Full-time
Closing Date
10th December 2021

Reports to:
Head of Biometrics

Key Requirements

1. Third level degree in biomedical/ life science.
2. Minimum of five years of experience in a Clinical Data Management environment.
Comprehensive knowledge of data management processes.
3. Experience in clinical data management systems, especially EDC systems such as iMedidata
Rave.
4. Excellent communication, organisational and problem-solving skills.
5. Team player as well as ability to work on own initiative.
6. Versatility and ability to work to deadlines.
7. Oncology background/ experience an advantage.
8. Proficiency in all Microsoft Office Tools.

Main Function(s)

To perform and lead Data Management (DM) tasks on assigned studies within Cancer Trials
Ireland.

Primary Responsibilities

• Perform DM tasks on allocated studies from Start-up (e.g. database build specifications) to
Close-out Activities (e.g. Database Lock/Archiving) in an effective and efficient manner.
• Proficiency in EDC technical tasks through all stages of a study.
• Lead DM activities with internal and external team members and collaborate with team
members to plan and deliver on Study Deliverables.
• Responsible for the DM File and ensuring audit readiness.
• Adhere to all related procedures and regulations, e.g. Study Guidelines, SOPs, ICH GCP etc
ensuring a high-quality standard is maintained for all assigned tasks.
• Proactively identify DM process improvements and efficiencies and contribute to the creation,
review and updating of DM SOPs.
• If applicable, perform MedDRA coding and utilise other standard DM tools.
• Review and ensure the quality of work performed by Clinical Data Coordinators/other team
members.
• Train and mentor other team members in relation to DM processes.
• Attend out of hours meetings from time to time
• Perform other tasks as specified by line manager/ CEO

 

Please apply directly to Jacinta.Marron@cancertrials.ie