Lead Data Manager

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.