Senior Clinical Data Lead

ICON is looking for a full-time Lead Data Manager to support one of our biotech clients!

Responsibilities
• Provide clinical data management support to clinical development franchise(s) and related Clinical Operations team and/or study project, Safety, Clinical Management team and Biostatistics.
• Participate in the review of clinical research documents (e.g., Protocols, Case Report Forms, Reports and Statistical analysis).
• Oversee deliverables, data quality of activities performed by contract research organizations (CRO) and central vendors that support studies.
• Ensures overall quality and timeliness of clinical studies from study implementation to database closure.
• Develop and collaborate with extended team on Data Management Plan (DMP), maintain DMP throughout lifecycle of study project and ensure DMP is followed according to study design and requirements.
• Ensure quality of all clinical trial EDC and central vendor data is fit for purpose and data acquisition, data cleaning activities and overall quality meet study team expectations.
• Organize and lead electronic Case Report Form (eCRF) development.
• Provide guidance to CROs for clinical trial database (CTDB) specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations that are compatible with company needs
• Perform sponsor risk-based user acceptance testing of database changes, database integrations and oversee testing performed by vendors.
• Develop Data Transfer Agreement(s) (DTAs) between external central vendors.
• Oversee CRO reconciliation of external vendor data and EDC.
• Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
• Ensure the integrity, confidentiality and security of all clinical data.
• Effectively communicates data management activities and status to study team members and escalates issues as needed.
• Author and/or review standard operating procedures and work instructions for data management activities
• Oversee vendor of electronic trial master file (eTMF) filing activities.

Qualifications

• Scientific background (B.S. degree or higher) with minimum 5 years clinical data management experience in the pharmaceutical/biotechnology industry.
• Applicable knowledge working with clinical databases such as Oracle, SAS, or high level of Microsoft Excel expertise. Strong skillset using Veeva eTMFs.
• Background in basic understanding of statistics.
• Ability to generate PowerPoint slides from data for internal and external presentations.
• Detail oriented while still maintaining work efficiency.
• Proficient in MedDRA and WHO Drug coding required.
• Previous experience with EDC required.
• Experience supporting eCTD submissions through the creation of CDISC/SDTM standard datasets is highly desired.
• Ability to prioritize activities and multi-task across various projects at different study stages.
• Demonstrate a high level of personal leadership, be self-motivated, well-organized, and be able to think strategically.



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.