Clinical Data Manager - eDiary Compliance

The Clinical Data Manager - eDiary Compliance is responsible for overseeing the development, implementation, and maintenance of processes to ensure adherence to regulatory guidelines and protocol requirements for electronic diaries (eDiaries) utilized in clinical trials. This role involves establishing monitoring strategies, conducting audits, and providing guidance to ensure data integrity and participant compliance throughout the study lifecycle. Additionally, the Clinical Data Manager - eDiary Compliance will develop participant engagement strategies to improve or maintain optimal compliance levels, with a target of achieving and maintaining overall eDiary compliance at 95% or more. The Clinical Data Manager - eDiary Compliance will collaborate closely with cross-functional teams and report to the Associate Director of Regulatory & Site Data Compliance

Duties & Responsibilities

• Develop, implement, and maintain processes to ensure compliance with regulatory guidelines and protocol requirements for eDiaries utilized in clinical trials
• Establish monitoring strategies to evaluate the effectiveness of eDiary processes and identify areas for improvement
• Conduct audits of eDiary systems and processes to assess compliance with regulatory requirements and protocol specifications
• Provide guidance and support to internal teams and external stakeholders on eDiary compliance requirements and best practices
• Monitor data integrity and participant compliance throughout the study lifecycle, including data entry, documentation, and reporting
• Develop participant engagement strategies to improve or maintain optimal compliance levels, including but not limited to reminders, incentives, and educational materials
• Ensure overall eDiary compliance is maintained at 95% or more, tracking compliance metrics and implementing corrective actions as needed to achieve targets
• Collaborate with cross-functional teams to address compliance issues and implement corrective actions as necessary
• Stay current with regulatory developments and industry trends related to eDiary compliance in clinical research
• Prepare and present compliance reports and findings to management as required
• Coordinate with Quality Assurance and Data Management teams to ensure alignment of eDiary compliance efforts with overall quality management processes
• Serve as a subject matter expert on eDiary compliance matters, providing training and support to team members as needed
• Assist in the development and implementation of departmental policies, procedures, and training programs related to eDiary compliance
• Participate in internal and external audits and inspections related to eDiary compliance, providing documentation and support as needed
• Lead or contribute to continuous improvement initiatives aimed at enhancing eDiary compliance processes and procedures
  
  

Knowledge & Experience

Education:

• Bachelor's degree in life sciences, health-related field, or equivalent experience required
  
  

Experience:

• Minimum of 5 years of experience in clinical research
• Minimum 2 years of team management experience
• Minimum 3-4 years of experience working in a highly collaborative environment
  
  

Credentials:

• ACRP-CP certification is preferred
• Project Management certification is preferred
  
  

Knowledge and Skills:

• Ability to interact professionally with a diverse group, including executives, managers, clinicians, and subject matter experts
• Strong communication skills and organizational skills with attention to detail
• In-depth knowledge of regulatory guidelines (e.g., FDA, ICH-GCP) and protocol requirements related to eDiaries in clinical trials
• Excellent communication and interpersonal skills, with the ability to effectively communicate compliance requirements and findings to diverse stakeholders
• Strong analytical and problem-solving skills, with attention to detail and accuracy
• Experience conducting audits and developing monitoring strategies to assess compliance
• Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment
• Proficiency in MS Office Suite and other relevant software applications
  
  

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