Senior Clinical Data Manager

Intego Group’s Biometric Department is expanding its clinical data management practice. We’re looking for bright individual to join our growing team n Orlando, Florida or remotely from all over the United States for a 12-months contract. You will be responsible for all aspects of clinical database review, cleaning, reporting, participating in database design and implementation, and client communication and team oversight. As a Clinical Data Manager, you will establish and maintain policies and procedures for gathering, analyzing, and reporting clinical trial data.

Job responsibilities:

The role of the Senior Clinical Data Manager is to ensure proper, accurate, and reliable information is collected during clinical trials. This involves the careful design of the data collection tools and data interpretation methodology, as well as close integration with other clinical study management functions. General responsibilities include:

• Review clinical trial data aligned with client SOPs and data review conventions to identify erroneous, missing, incomplete, or implausible data.
• Perform query production, resolution, and tracking to resolve any problematic data identified during the review. Update the database accordingly.
• Create and/or review data management documentation, completion guidelines, DMP, DVS, and other specifications.
• Take part in EDC system and CRF components design and testing.
• Interact with clinical, programming, and other project teams, as necessary.
• Communication with the client/sponsor, leading the project.
• Team oversight and tasks planning.

Required experience, education, and skills:

Applicants must demonstrate the potential ability to perform the essential functions of the job responsibilities as outlined in the position description. General requirements:

• Bachelor's Degree, or educational equivalent, in health, clinical, biological, or related discipline, and 3 to 5 or more years direct data management experience.
• Knowledge of medical terminology, pharmacology, anatomy, and/or physiology.
• Knowledge of operating procedures and work instructions and the ability to apply them in practice.
• Knowledge of GCP and relevant regulatory guidelines.
• Excellent communication, interpersonal, customer service, and teamwork skills.
• Excellent organizational and analytical skills.
• Comprehensive understanding of the clinical drug development process.
• Experience with electronic Clinical Database Systems is required, and experience with electronic reporting applications is preferred.
• Experience with an electronic data capture (EDC).
• Ability to maintain a high degree of confidentiality with clinical data and proprietary data.
• Ability to use interactive computer programs, such as MS Word, Excel, PowerPoint.
• Extensive data management skills and thorough knowledge of the data management process (e.g., therapeutic area, deep understanding in DM processes, SAE reconciliation/pharmacovigilance, medical review, external data vendor reconciliation, management of central/local laboratory data, and/or new technology).

All interested candidates should submit their resumes to job@intego-group.com