Full-time
Posted 27 days ago
Job description
- Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.
- Oversee data cleaning, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions.
- Collaborate with external data management vendors to ensure timely and high-quality deliverables, track performance against project timelines and quality standards.
- Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (e.g., NDA, BLA, MAA).
- Ensure compliance with industry standards and regulations (GCP, FDA, EMA) and assist in audit and inspection readiness.
- Coordinate with internal stakeholders including Clinical Operations, Biostatistics, Regulatory Affairs, and IT to ensure smooth data integration and reporting.
- Contribute to the implementation and optimization of clinical data systems and tools (e.g., EDC, data review platforms).
- Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field.
- 7+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry.
- Experience managing study-level data management activities and working with external vendors.
- Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM).
- Demonstrated experience supporting regulatory submissions is a plus.
- Strong problem-solving, organizational, and communication skills.
Most Popular Clinical Data Manager Job Categories
Clinical Data Science
Junior Clinical Data Manager
Clinical Data Standards
Full Time Data Science Neuroscience
Nurse Data Abstraction
Remote Clinical Data Manager
Freelance Clinical Data Manager
Clinical Data Management
Tcs Clinical Data Management
Part Time Clinical Data Manager
Other Helpful Pages Related To Clinical Data Manager
Remote Clinical Data Abstractor Salaries
Frequently asked questions
Q: What skills or qualities help someone succeed as a Clinical Data Manager?
A: To succeed as a Clinical Data Manager, key technical skills include proficiency in Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC) systems, and data management software such as SAS or R. Additionally, strong domain-specific skills in clinical research regulations, Good Clinical Practice (GCP), and data validation are essential.\n\nSoft skills that contribute to success in this role include strong organizational and time management skills, effective communication and collaboration with cross-functional teams, and attention to detail and analytical thinking to ensure data accuracy and integrity. These strengths enable Clinical Data Managers to efficiently manage large datasets, identify and resolve data discrepancies, and maintain compliance with regulatory requirements.\n\nBy possessing these technical and soft skills, Clinical Data Managers can effectively oversee data collection, cleaning, and analysis, ultimately supporting the success of clinical trials and contributing to the growth of their careers in the pharmaceutical or biotechnology industry.
Q: What is the career path for a Clinical Data Manager?
A: A Clinical Data Manager's career path typically begins with entry-level roles such as Clinical Data Coordinator or Data Associate, where they assist in data management, cleaning, and reporting. As they gain experience, they progress to mid-level roles like Clinical Data Manager or Senior Data Coordinator, overseeing data management processes, implementing data standards, and collaborating with cross-functional teams. Senior Clinical Data Managers or Lead Data Managers then assume leadership roles, overseeing large-scale data management projects, developing data management strategies, and mentoring junior staff, ultimately positioning themselves for senior leadership or specialized roles in data science, regulatory affairs, or clinical operations.
