Senior Clinical Data Manager

Our client, a cutting-edge biopharmaceutical company, is seeking a highly skilled and experienced Senior Clinical Data Manager for a fully remote position. You will lead the clinical data management activities for critical pharmaceutical research projects, ensuring the accuracy, completeness, and integrity of data collected from clinical trials. This remote role demands meticulous attention to detail, strong leadership capabilities, and a deep understanding of data management best practices within the pharmaceutical industry.

Your work will directly contribute to the successful development of life-saving therapies.

• Oversee the design, development, and implementation of clinical databases, including edit specifications and data validation plans.
• Manage all aspects of clinical data collection, cleaning, and database lock processes.
• Ensure compliance with Good Clinical Practice (GCP), HIPAA, and other relevant regulatory guidelines (e.g., FDA, EMA).
• Lead data management team members, providing guidance and mentorship.
• Collaborate with clinical operations, biostatistics, and programming teams to ensure data quality and timely delivery.
• Develop and maintain data management SOPs and work instructions.
• Perform data review and query management activities, ensuring timely resolution of data issues.
• Contribute to the development of data management sections of study protocols and other relevant documents.
• Manage vendor relationships for clinical data management services as needed.

• Bachelor's degree in a relevant scientific or technical field (e.g., Computer Science, Statistics, Life Sciences).
• Minimum of 7 years of progressive experience in clinical data management within the pharmaceutical or biotechnology industry.
• Extensive experience with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical).
• Proficiency in database design, data validation strategies, and clinical data cleaning processes.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements for clinical data.
• Excellent leadership, communication, and interpersonal skills, crucial for remote team management.
• Proven ability to manage multiple complex projects simultaneously and meet tight deadlines.
• Proficiency in data management software and standard office applications.
• Familiarity with the pharmaceutical landscape relevant to Queenstown, Eastern Cape, while not a location requirement due to remoteness, indicates a broad understanding.

This is an exceptional opportunity for a Senior Clinical Data Manager to work remotely for a leading biopharmaceutical company. Our client offers a highly competitive salary, comprehensive health, dental, and vision insurance, a generous retirement savings plan, ample paid time off, and substantial opportunities for professional growth and leadership development. Join a forward-thinking organization that values innovation and collaboration.