Job Description

Our start-up, clinical-stage medical device client, is adding a Clinical Data Manager to the team. The Clinical Data Manager will support operational activities related to the organization's sponsored clinical research programs. Primary responsibilities are management of all aspects of clinical database design, development, and validation, including but not limited to case report form and report development, and query management. The Clinical Data Manager will establish, standardize, and maintain all policies and procedures necessary for the proper handling, analysis, and reporting of clinical data for all US and international (OUS) clinical trials. This position may be expected to analyze clinical data to identify trends, provide strategic input to clinical study design, and contribute to departmental budget development.

Your role with the company:

• Support CRF design and clinical protocol development.
• Design and validate clinical databases, including logic checks.
• Assist with the collection, aggregation, and analysis of data.
• Process clinical data, including receipt, entry, verification, and filing of information related to data queries.
• Develop data management plans that address coding, reporting, transferring, and processing of clinical data.
• Workflow development.
• Design forms, reports, or processes necessary for receiving, processing, tracking, trending and reporting of clinical data.
• Experience with trial master file (TMF) development and maintenance.
• Monitor applicable vendor performance to ensure timelines and data quality standards are met.
• Ensures quality meets agreed upon specifications per the DMP and scope of work.
• Perform duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.
• Serve as a clinical data management expert and provide guidance on CDISC standards.
• Develop and deliver study specific training for DM project staff.
• Represent the data management functions in client-facing and internal meetings.

Desired Profile:

• Bachelor's or graduate degree in a science-related discipline, ideally with experience in health administration and a concentration in mathematical subjects, including statistics.
• Minimum of 5 years of experience as a Clinical Data Manager at a medical device company.
• Experience with implantable cardiology-related products and technologies preferred.
• Knowledge of HIPAA, FDA/EU regulations, and Good Clinical Practices is essential.
• Demonstrated capabilities with statistics, writing protocols, data transfer, data sets, and spreadsheets.
• Critical thinker with strict attention to detail and solid collaboration and problem-solving skills required.
• Experience with eCRFs, CRF, SAS, eTMF, and clinical data software and systems.

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