Clinical Data Manager

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

📋 Description

• Review study protocols and oversee clinical data management tasks during the initiation of studies.

• Develop data collection strategies that align with the objectives outlined in the protocol and study endpoints.

• Collaborate with investigators and research teams to create metadata and specifications for data capture.

• Work alongside Clinical Data Programming personnel to set up and validate electronic data capture (EDC) systems.

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

• Generate study calendars and schedules for data collection.

• Conduct Operational Qualification (OQ) and Performance Qualification (PQ) testing of databases and study systems.

• Create guidelines for case report form (CRF) completion and develop user documentation.

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

• Identify and document necessary database modifications to accommodate protocol amendments and study alterations.

• Execute quality control reviews to ensure the accuracy, completeness, and compliance of data with regulatory standards.

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

⛳️ 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 working within a multi-modality clinical trials group or research team is advantageous.

• Familiarity with CDASH/CDISC Standards is a plus.

• Proficiency in using electronic data capture (EDC) platforms is required.

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

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

• Excellent organizational, communication, and teamwork skills are required.

• The ability to juggle multiple priorities in a fast-paced, team-oriented setting is necessary.

🏝️ Benefits

• Defined contribution pension plan.

• 403(b) retirement plan.

• Generous paid time off package.

• Insurance plans with leading providers.

• Flexible spending options.

• Tuition reimbursement opportunities.

• Access to training programs.

• Wellness reimbursement benefits.

• Potential for professional growth.

• Competitive salary.

• An exceptional benefits package.