Lead Data Manager
- United States
- Clinical Data Management, Clinical Data Scientist Lead, Clinical Systems, Data Standards Consultant
- ICON Strategic Solutions
About the role
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Overview:
Our client is looking for a Lead Data Manager with at least 5 years of lead experience to work dedicated to support their studies!!
What you will be doing:
- Review, analyze, and validate clinical trial data throughout the study lifecycle to ensure data consistency, integrity, and accuracy based on project specific guidelines;
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures (SOPs), protocol requirements, and regulatory agency guidelines;
- Generate and review reports and listings as required to maintain data integrity and reporting;
- Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers and interim data reporting;
- Assist in cleaning data for study close out and perform database lock procedures;
- Execute a variety of administrative tasks including but not limited to filing, printing, formatting deliverables, creating binders and other study admin tasks as warranted;
- Develop and maintain study specific documentation and data management guidelines;
- Generate data retrievals and summaries as required;
- Provide accurate, timely, and consistent clinical data to internal staff to support business objectives;
You are:
- Bachelor’s Degree, preferably in life sciences;
- Extensive clinical data management experience Pharmaceutical and/or CRO setting. 5-8 years’ experience in clinical data management;
- Proficient in Microsoft Word, Excel, and PowerPoint and EDC systems, preferable Medidata Rave;
- Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements;
- Excellent verbal and written communications skills;
- Strong interpersonal skills with demonstrated capability of working on multiple projects simultaneously;
- Ability to complete deliverables on time and adjust priorities in a fast-paced environment;
- Demonstrated ability to provide coaching and training to new hires and less-experienced staff;
- Comprehension of medical terminology desirable.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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