Principal Clinical Data Manager

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Company: Katalyst HealthCares and Life Sciences

Location: Philadelphia, PA 19120

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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