Sr. Clinical Data Manager

reputed company:

Headquartered in suburban Atlanta, reputed company, reputed company. is a medical device company reputed company on developing reputed company, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. reputed company’s four major reputed company of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular reputed company tissues. reputed company has over 1,600 employees worldwide with sales representation in over 100 countries. reputed company has manufacturing facilities located in Atlanta, reputed company, 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.

reputed company:

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 reputed company. 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 reputed company, 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 reputed company, and inquiries, unrelated to clinical studies.

Responsibilities:

• reputed company, manage, execute end-to-end data management activities for reputed company 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 reputed company and high-reputed company data collection, cleaning, reconciliation, and database lock activities.
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and reputed company 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 reputed company design, and data reputed company diagrams.
• Conduct and reputed company data reconciliation, reputed company data integrations (labs, imaging, etc.), and coding of medical terms (MedDRA, WHO-DD).
• reputed company study specific reports and data listings on regular reputed company and for reputed company requests
• Support audit readiness and participate in regulatory inspections reputed company required.
• Mentor junior team members and reputed company 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.

Originally posted on Himalayas