REMOTE Senior Clinical Data Manager

Company: ProPharma Group
Location: Cleveland
Posted on: May 16, 2022

Job Description:

*Please note when applying, this is a remote one year contract with the possibility of extension

Senior Data Manager (Remote)
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 closeout 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
Qualifications:
Bachelor's Degree, preferably in life sciences;
Extensive clinical data management experience in Pharmaceutical and/or CRO setting. 5-8 years experience in clinical data management;
Proficient in Microsoft Word, Excel, 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 is of medical terminology is desirable.

Keywords: ProPharma Group, Cleveland , REMOTE Senior Clinical Data Manager, Executive , Cleveland, Ohio