Clinical Data Manager, Sr. (remote)

Arthrex • Pelican Bay, FL

76d • $79,001 - $140,000

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Clinical Data Manager. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better. Main Objective: Act as the primary liaison for data management deliverables on assigned studies. Provide senior-level guidance and support to the Data Managers team across multiple large-scale studies. Supervise the preparation of data collection forms, database design, specification and testing, cleaning, locking, extracting, and reporting on study progress for internal and external stakeholders. Collaborate with clinical research, data managers, and other internal teams, focusing on continuous process enhancement, issue resolution, workload forecasting, and technical consultation. Participate in data management strategies for regulatory and marketing initiatives.

Requirements

• Bachelor's degree required. Preferably in Business, Life Science, or Computer Science.
• Master's degree preferred. Preferably in Business, Life Science, or Computer Science.
• At least 6 years of clinical data management experience is required (3 years of that time as a study lead role preferred).
• Clinical Data Management certification (i.e. CCDM) is preferred (required to be obtained within 1 year of hire if not already held).
• Demonstrate knowledge of ICH/GCP guidelines as they relate to data management is required.
• Demonstrate knowledge of ISO standards preferred.
• Demonstrate knowledge of FDA Regulations related to data handling and processing, which is required.
• A thorough understanding of CDISC CDASH and SDTM standards is preferred.
• Prior trial responsibility of the entire data management lifecycle is required.
• Experience working with medical device trials is preferred.
• Knowledge of EDC and Clinical Data Management Systems required.
• Comprehension of medical terminology or reference literature for understanding is required.
• Proficiency in Microsoft Office Applications, specifically in MS Excel, is required.
• Experience in vendor oversight is preferred.
• Experience in leading or mentoring clinical data teams is preferred.

Responsibilities

• Lead data management efforts for internal and outsourced studies; may manage staff responsible for performing those activities.
• Lead data management activities, including creation of data management plans and data review plans (DMP & DRP), as well as training materials.
• Lead development and review of SOPs, work instructions, and associated documents for CDM, including recommendations, revisions, and updates to SOPs.
• Creates and enforces processes for effective database build and data management in EDC, CTMS, ePRO and eTMF systems.
• Support the development of study-specific database builds using study protocol and configuration specifications.
• Is compliant with project and data management plans for data handling and sharing with the clinical research team.
• Oversees/Performs User Acceptance Testing (UAT).
• Supports the clinical research team and sites in the daily use of data systems and ensures adherence to legal and company standards.
• Facilitate stakeholder training of data management systems.
• Lead manual listing review activities according to the DMP and DRP.
• Manage ongoing query review with closures of system-generated queries according to the DMP and DRP.
• Lead the distribution of data reports, extracts, and other deliverables as defined in the data management plan.
• Conducts data management meetings as appropriate and provides clinical team updates regarding data listings, issues, cleaning, and locking.
• Lead and coordinate the creation of study-specific eCRF Completion Guidelines.
• Assures databases and archives are protected from security breaches and losses.
• Manage troubleshooting activities for data-related problems.
• Manage clinical data cleaning and delivery activities including database lock.

Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree