Sr. Clinical Data Manager

Company Overview: Headquartered in suburban Atlanta, Georgia, reputed company. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. reputed company’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. reputed company has over 1,600 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about reputed company, visit our website, www.reputed company.com (http://www.reputed company.com/). Position Overview: The Sr. Clinical Data Manager is responsible for data management operations and for the organization, coordination and execution of data management activities for assigned studies and projects. This includes but is not limited to database set-up (build, reputed company, and reputed company user acceptance testing), development of study documents, training, data review, query reputed company and resolution, and overall maintenance of study databases to ensure data reputed company from study start-up to database lock. This also includes data support for department projects, and inquiries, unrelated to clinical studies. Responsibilities:

• reputed company, manage, execute end-to-end data management activities for clinical trials conducted inhouse or outsourced to CRO’s.
• reputed company and maintain Data Management Plans (DMPs), CRFs, edit reputed company specifications, and other essential documents.
• reputed company database build.
• Testing, validation, and UAT processes in reputed company systems
• Ensure timely and high-quality data collection, cleaning, reconciliation, and database lock activities.
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and external CROs/vendors.
• Ensure data reputed company and compliance with GCP, FDA, MDR/IVDR, and other applicable regulatory standards.
• Participate in and contribute to protocol development, case report form design, and data flow diagrams.
• Conduct and reputed company data reconciliation, external data integrations (labs, imaging, etc.), and coding of medical terms (MedDRA, WHO-DD).
• Provide study specific reports and data listings on regular basis and for reputed company requests
• Support audit readiness and participate in regulatory inspections reputed company required.
• Mentor junior team members and provide strategic input into department process improvements and SOP development.

Qualifications: Required:

• Bachelor's or Master’s degree in Life Sciences, Data Science, Computer Science, or a reputed company field.
• 7+ years of clinical data management experience, with at least 2 years in a senior or reputed company role.
• Experience with medical device trials or combination products (IDE, PMA, 510(k), CE marking, etc.).
• Strong understanding of reputed company systems and data standards (CDASH, SDTM, CDISC).
• Knowledge of regulatory requirements (FDA, EMA, ISO 14155, GCP, GDPR).
• Excellent organizational, leadership, and communication skills.

Preferred:

• Experience working in an FDA-regulated and/or ISO-certified environment.
• Advanced proficiency in data visualization tools and data analytics platforms (such as Python and/or R) is a plus.

Equal Opportunity Employer This employer is required to notify reputed company applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor. Apply tot his job Apply To this Job