Clinical Data Manager

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Evaluate study protocols and oversee clinical data management tasks throughout the study initiation phase.

• Create data collection methods that align with the objectives of the protocol and the endpoints of the study.

• Work collaboratively with investigators and research teams to establish metadata and specifications for data capture.

• Collaborate with Clinical Data Programming personnel to set up and validate electronic data capture systems.

• Develop edit checks, web logic, and validation specifications to enhance data quality and consistency.

• Generate study calendars and schedules for data collection.

• Conduct Operational Qualification and Performance Qualification testing for databases and study systems.

• Create guidelines for case report form completion and user documentation.

• Produce standard, study-specific, and ad hoc reports to facilitate study oversight and decision-making.

• Identify and document necessary database modifications for protocol amendments and study changes.

• Execute quality control reviews to ensure data accuracy, completeness, and adherence to regulatory standards.

• Act as a resource for site research staff, offering guidance on protocol requirements and data collection processes.

⛳️ Requirements

• A minimum of 3 years of relevant experience is preferred.

• A professional nursing degree, other healthcare certification, or a bachelor's degree is preferred.

• Experience in a multi-modality clinical trials group or research team is an advantage.

• Familiarity with CDASH/CDISC Standards is a plus.

• Experience with electronic data capture (EDC) platforms is required.

• Certification as a Medidata Rave Study Builder is a plus.

• Strong attention to detail and a commitment to data quality and process excellence are required.

• Excellent organizational, communication, and collaboration skills are essential.

• Ability to handle multiple priorities in a fast-paced, team-oriented environment is necessary.

🏝️ Benefits

• Defined contribution pension plan.

• 403(b) plan.

• Generous paid time off package.

• Insurance plans offered by leading providers.

• Flexible spending options.

• Tuition reimbursement.

• Opportunities for training.

• Wellness reimbursement.

• Potential for professional growth.

• Competitive compensation.

• Exceptional benefits package.