Clinical Data Manager
6 days ago
Job Profile: Clinical Data Manager
Position: Clinical Data Manager
Location: Home based
Department: Clinical Operations
Reports To: AD/Director of Clinical Operations / Clinical Research Manager
Job Summary:
The Clinical Data Manager will be responsible for overseeing the data management processes for clinical trials, ensuring the accuracy, integrity, and security of clinical data. This role involves coordinating with cross-functional teams to design, implement, and maintain data management systems and protocols. The ideal candidate will have a strong background in clinical data management, exceptional attention to detail, and excellent organizational skills. PLEASE NOTE: ONLY CANDIDATES WITH UPDATED CV AND AN INTRO VIDEO WILL BE PROCESSED.
Medidata experience is required.
Key Responsibilities:
1. Data Management and Oversight:
o Design and implement data management plans and standard operating procedures (SOPs).
o Develop and maintain data collection tools, including case report forms (CRFs) and electronic data capture (EDC) systems.
o Ensure data accuracy, completeness, and consistency throughout the clinical trial lifecycle.
2. Data Quality and Validation:
o Perform data validation and verification to ensure compliance with regulatory requirements and study protocols.
o Identify and resolve data discrepancies and inconsistencies in a timely manner.
o Conduct data cleaning and manage data quality control processes.
3. Collaboration and Coordination:
o Work closely with clinical research coordinators, data analysts, and other stakeholders to ensure seamless data collection and management.
o Provide training and support to study staff on data management procedures and tools.
o Coordinate with external vendors and partners involved in data collection and management.
4. Regulatory Compliance:
o Ensure that all data management activities adhere to regulatory guidelines, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) standards.
o Prepare and review data management documentation for regulatory submissions and audits.
5. Reporting and Analysis:
o Generate regular and ad hoc data reports for internal and external stakeholders.
o Assist in data analysis and interpretation to support study results and decision-making.
6. Continuous Improvement:
o Identify opportunities for process improvements in data management and implement best practices.
o Stay current with industry trends and advancements in data management technologies.
Qualifications:
• Education: Bachelor's degree in Life Sciences, Computer Science, Data Management, or a related field. Advanced degree or certifications (e.g., Clinical Data Management certification) is a plus.
• Experience: Minimum of 3-5 years of experience in clinical data management or a related field, with a strong understanding of clinical trial processes and data management systems.
• Skills:
o Proficiency in data management software and tools (e.g., EDC systems, data visualization tools).
o Strong analytical skills with a keen eye for detail.
o Excellent organizational and project management abilities.
o Effective communication and interpersonal skills.
o Ability to work both independently and as part of a team.
How to Apply:
Interested candidates should submit their resume and a cover letter detailing their relevant experience and qualifications to with the subject line "CLINICAL DATA MANAGER". PLEASE ATTACH THE LINK OR SHORT VIDEO INTRODUCTION OF YOURSELF HIGHLIGHTING YOUR EXPERTISE AND EXPERIENCE AS A VIRTUAL CDM.
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