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Clinical Data Lead

hace 1 mes

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Job Summary

ICON plc is a world-leading healthcare intelligence and clinical research organization. We advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations.

Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life. We achieve this by working with our patients at the center of all that we do.

We are seeking a Clinical Data Lead to join our team. The successful candidate will take a leadership role with the CRO, trial customers, and other internal and external partners to establish, align, and confirm data management expectations for assigned trials.

The Clinical Data Lead will gather content and integration requirements for eCRF and other data collection tools. They will establish conventions and quality expectations for clinical data, set timelines, and follow up regularly to ensure delivery of all Data Management milestones.

The ideal candidate will have 5+ years of clinical data experience and 3+ years of Lead Data Management experience. They will possess solid EDC system(s) experience and be able to present and train at investigator and monitor meetings.

We offer a comprehensive and competitive total reward package that comprises an excellent level of base pay, variable pay, and recognition programs. Our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career.

We are committed to providing a work environment that is inclusive, diverse, and respectful. If you are passionate about clinical data management and want to make a difference in the lives of patients, we encourage you to apply for this exciting opportunity.

Key Responsibilities:

  • Takes a leadership role with the CRO, trial customers, and other internal and external partners to establish, align, and confirm data management expectations for assigned trials.
  • Gathers content and integration requirements for eCRF and other data collection tools.
  • Establishes conventions and quality expectations for clinical data.
  • Sets timelines and follows up regularly to ensure delivery of all Data Management milestones.
  • Performs trial-level oversight controls as described in the oversight plan, QC process, and work instructions with minimal DML direction.
  • Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
  • Ensures compliance with regulatory guidelines and the documentation matrix.
  • Ensures real-time inspection readiness of all IDS deliverables for the trial; participates in Regulatory Agency and internal audits as necessary.
  • Plans and tracks content, format, quality, and timing of data management deliverables, including but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan, and archival.
  • Ensures deliverables are on time.
  • Takes a leadership role with the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met.
  • Identifies and communicates lessons learned, best practices, and frequently asked questions at the trial level.
  • Identifies and participates in process, system, and tool improvement initiatives within IDS.
  • Presents and trains at investigator and monitor meetings.