Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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.