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 is an In-Office position (Not remote).

This person 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, 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 and internal study personnel.
• Implement and oversee data validation processes to ensure data integrity and compliance with study protocol and industry standards.
• Development and maintenance of Data Management Plan for 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.
• Contributes to study protocols and study reports.
• 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

KNOWLEDGE, SKILLS, AND ABILITIES:

• Must have experience with CRF development, EDC systems, preferably Clindex, and electronic Trial Master File (eTMF) systems.
• Must have working knowledge of Good Clinical Practices (GCPs) and FDA regulations
• Must have strong project management competencies and ability to work with high quality, reliability, and attention to detail.
• Must have a strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross-functionally, and with clients/partners.
• Must have proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint.
• Familiarity with medical and anatomical terminology.

EDUCATION & EXPERIENCE REQUIREMENTS:

• A minimum of 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 science, data management, or similarly related field .
• Travel requirement 10%

Additional Information

WORK ENVIRONMENT: 

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of