Clinical Data Lead

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

What you will be doing:

• Takes a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
• With the trial customer, CRO and other functional partners:
• Gathers content and integration requirements for eCRF and other data collection tools.
• Establishes conventions and quality expectations for clinical data.
• Establishes expectations for dataset content and structure.
• Set timelines and follow-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; Participate 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.

You possess:

• 5+ years of clinical data experience
• 3+ years of Lead Data Management experience
• Solid EDC system(s) experience

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