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Details

Senior Clinical Data Management Associate


Reference:KS/AKAJ-456621 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Our client is a Global Biopharma who are establishing a Paediatric Centre of Excellence in Dublin that will be responsible for the management and execution of Paediatric Clinical Trials, across all therapeutic areas, around the world. The Clinical Operations team in Dublin is a pivotal function within this Centre of Excellence. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of our clients products.

The Clinical Operations team are now seeking a Senior Clinical Data Management Associate to join the team. If you are seeking a role in a Global Biopharma & have experience of clinical trial data management this is an excellent opportunity. The successful person will be joining a newly established group in Ireland who will work closely to transfer all the processes across from the US and carry on the Paediatric Virology trials in the first instance.

Role/Responsibilities:

  • Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, Global Patient Safety, Regulatory and Project Management staffs to meet project deliverables and timelines for non‐ routine clinical data acquisition, quality checking and reporting.
  • Ensures completeness, accuracy and consistency of clinical data and data structure.
  • Ensures adherence to standard business processes within CDM systems to ensure compliance to regulatory bodies.
  • May lead in the design and implementation of clinical data management process with vendors including data entry, data quality checking, data transfer and reporting.
  • Leads the preparation and design of CRF/eCRFs.
  • Reviews study protocols and assist in the planning and implementation of the data management portions of clinical studies.
  • Interact with site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner.
  • Utilizes reports to track study progress and ensure timeliness and quality expectations are met.
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • The ability to problem solve. Exceptional people/project leadership skills are required.
  • General knowledge of FDA/EMA regulations and with web‐based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA is also required.
Key Contributions
  • Capable of handling studies that are complex in scope and volume.
  • Effectively interacts with vendors to communicate expectations for study timelines and milestones.
  • May lead the design and implementation of the clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
  • Demonstrates ability to appropriately delegate tasks to CDMA I and CDMA II staff members.
  • Provide technical and business process input/expertise on new and emerging technologies/vendors for clinical trial execution.
  • Demonstrates strong facilitation/ presentation skills.
  • May act as a mentor to junior employees.
Education/Experience
  • BSc degree.
  • 5+ clinical data management experience.
For further details please contact Karen Shiel on 087 745 2487 or send CV to karen.shiel@lifescience.ie