Clinical Data Manager

Company Description

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

POSITION SUMMARY:

The In-House Clinical Data Manager will be responsible for a range of data management tasks, contributing to the success of clinical trials and regulatory submissions in accordance with Good Clinical Practices and applicable regulations including the Code of Federal Regulations (CFRs). This position will be called upon to act with flexibility to take on additional trial management tasks directed by the clinical project manager as needed.

PRIMARY RESPONSIBILITIES:

• Support the organization and execution of data management activities for clinical trials, including Case Report Forms (CRFs) and Electronic Data Capture (EDC) System.
• Manage the creation, maintenance, and validation of clinical databases to ensure data quality and integrity in accordance with GCP and applicable regulations.
• Conduct and supervise user acceptance testing for clinical trial EDC to ensure user and regulatory requirements are met.
• Develop and maintain EDC training materials for the training of study site personnel, internal study personnel and third-party vendors where needed.
• Implement and oversee data validation processes to ensure data integrity and compliance with study protocols and industry standards.
• Development and maintenance of Data Management Plans for all Treace sponsored clinical trials.
• Manage and coordinate data-related activities throughout the clinical trial lifecycle.
• Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks. Lead efforts in building a standard query library for common database modules.
• Generate standard and ad hoc reports of EDC CRF or metric data for study team and management reporting.
• Lead the planning, execution, and tracking of data analysis projects, ensuring they align with the study objectives.
• Collaborate with biostatistician during database locks and QC of clinical trial data in preparation of reporting data.
• Contribute to study protocols and study reports, particularly as it relates to the development of tables, listings and figures (TLFs) for study data.
• Prepare and ensure the accuracy and completeness of clinical trial data for regulatory submissions, publications, posters, and presentations.
• Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving clinical trial data and study documentation.

Qualifications

EDUCATION & EXPERIENCE REQUIREMENTS:

• 3+ years of directly related data management experience or equivalent clinical research experience, including work on medical device trials.
• BS or BA degree required, preferably in a life science-related discipline, data management, or a similarly related field.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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