Job Description

Responsibilities:

• Lead data management activities, ensuring accuracy, consistency, and compliance with regulatory standards.
• Oversee database build activities, data collection, coding, cleaning, and database lock.
• Develop and execute data management plans, including risk management strategies.
• Work closely with internal and external stakeholders, including Biostatistics, Clinical Development, Quality Assurance, and Regulatory Affairs, to facilitate seamless data flow and compliance.
• Serve as the primary data management contact for assigned therapeutic areas, ensuring proper planning and issue resolution.
• Ensure timely and quality deliverables within project timelines and budget constraints.
• Develop and implement validation checks, conduct data reviews, and resolve data discrepancies to maintain high data standards.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and CDISC standards.
• Supervise database development, validation, and transfer processes in accordance with SOPs and regulatory requirements.
• Provide subject matter expertise in clinical data management systems, electronic data capture (EDC) platforms, and data standards such as CDISC.
• Develop and manage electronic Case Report Forms (eCRFs), data transfer specifications, and validation reports.
• Establish and refine data management standard operating procedures (SOPs) and best practices.
• Mentor and train junior data managers, fostering a collaborative environment and continuous learning culture.
• Ensure direct reports have adequate training and skills to meet regulatory and company standards.
• Guide teams on clinical data management best practices and evolving industry requirements.
• Maintain GCP inspection readiness by ensuring proper documentation and compliance with regulatory requirements.
• Serve as the primary point of contact for data management activities during audits and inspections.
• Review and approve key project documents, including Data Management Manuals, CRF Completion Guidelines, and validation specifications.

Requirements:

• Bachelor's degree in clinical, biological, or mathematical sciences, nursing, or a related field.
• Minimum of 6+ years of clinical data management experience in pharmaceutical development or CRO environment.
• Extensive experience with clinical trials, EDC databases, IRT systems, and diary applications for data collection.
• Strong knowledge of GCP, ICH, FDA, and CDISC regulatory requirements governing clinical studies.
• Proven ability to develop SOPs, risk management strategies, and data management plans.
• Demonstrated leadership, problem-solving, and project management skills.
• Excellent organizational, communication, and collaboration skills with a team-oriented approach.
• Self-motivated with a commitment to high-quality, on-time deliverables.

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