Clinical Data Lead

Overview

The Clinical Data Manager performs activities pertaining to Phase I- III clincial trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.

Responsibilities 

• Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange.
• Participate in protocol development and review; participate in review of clinical study reports and statistical analysis plans, as required.
• Review and provide input to CRF design and ‘CRF Completion Instructions’.
• Develop test scripts and perform user acceptance testing and validation of the database used to collect the clinical data to ensure that they meet requirements for the entry and reporting of clinical data.
• Perform training for appropriate users of the clinical data management system, as required.
• Produce ad-hoc or standard listings of data from the clinical data management system using the reporting tools provided, as required.
• Contribute to the ongoing development, review and revisions of Clinical Data Management Standard Operating Procedures (SOPs).
• For outsourced studies:
  • Collaborate with the Clinical Research Organization (CRO) project team to ensure that study deliverables and timelines are met and to act as the primary point of contact for data management interactions with the CRO.
  • Participate in the development of proposal specifications, review CRO proposals and budgets and assist in the selection of CROs for outsourced work.
  • Monitor the quality of Data Management processes, data and CRO performance.

Qualifications

• Bachelor’s degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT).
• Minimum of 5 years of data management experience.
• Project management experience is required.
• Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required.
• Oncology, endocrine and/or inflammatory therapeutic area experience is preferred.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, 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 - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.