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Clinical Data Manager

Contract Type: Permanent
Location: Dublin
Contact Name: Larry O’Leary
Contact Email: larry@rftgroup.ie

Job Description

Clinical Data Manager
Our client, a Biopharma company with strong development pipeline and multiple blockbuster products, now seeks a Clinical Data Manager, who will work with internal and external colleagues and vendors to support the Clinical Development and Operations functional teams, with clinical data through efficient CRF/eCRF design, edit specifications, and query resolution processes.

The successful hire will lead for one or more complex studies and the point of contact for study management team to meet project deliverables and timelines for non-routine clinical data acquisition, quality checking and reporting.

This will include leading the preparation and design of CRF/eCRF’s, interacting with site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements.

Additionally, this hire will be involved and/or leading in the design and implementation of clinical data management process with vendors including oversight of data entry, data quality checking, data transfer and reporting.

Job Responsibilities for Clinical Data Manager:
  • Reviews study protocols and assist in the planning and implementation of the data management portions of clinical studies.
  • Ensures adherence to standard business processes within CDM systems to ensure compliance to regulatory bodies.
  • Ensures completeness, accuracy and consistency of clinical data and data structure.
  • 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.
  • 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.

Requirements for Clinical Data Manager:
  • BS degree qualified, or MS or PhD.
  • 5+ years relevant years of experience, in similar or related role.
  • Exceptional people/project leadership skills are required, with experience in leading studies / projects without supervision oversight.
  • Able to provide oversight for the execution of data management activities.
  • 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 CDA I and CDA 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.
Please phone Larry on +353 (0)1-2302400 / larry@rftgroup.ie

The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie

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