Sr. Manager, Clinical Data Management - #1399196

Job Description

The Senior Manager, CDM oversees clinical data management activities across multiple studies from study start-up through study closure. This includes prioritizing projects in support of corporate goals and objectives and developing and/or enhancing data management processes to ensure complete, accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties:

• Develop and implement SOPs to ensure GCP/ICH compliance for data management, database operations, clinical report writing, case report forms, and associated procedures.
• Participate on corporate global clinical research teams ensuring that colleagues are updated on all relevant issues.
• Assist in budget planning and resource allocation as it relates to data management.
• Develop and implement clinical trial database, including CRF development and all aspects of data management.
• Manage, plan, and coordinate the activities of the data management team members.
• Oversee data management vendors, ensuring requirements are met and consistent.
• Audit data management vendors, as appropriate.
• Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines.
• Review and approve CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans.
• Review study documents, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells.
• Participate in the development of EDC User Acceptance Test (UAT) and custom report specifications as needed.
• Plan, manage and coordinate all data management activities to ensure consistency of clinical data process across studies.
• Work collaboratively with biostatistics, programming and other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.Contribute to activities supporting audits & inspection readiness and regulatory inspections.
• Performs additional responsibilities as assigned.
  
  

Qualifications

• Bachelor’s degree in Science, Computer Science, or equivalent combination of training and experience.
• Minimum seven (7) years of clinical data- management experience in the pharmaceutical, device or CRO setting.
• Previous supervisory experience.
• Proven ability to prioritize and manage multiple tasks with conflicting deadlines in support of corporate goals and objectives.
• Experience reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans, Data Transfer Plans.
  
  

Desired Qualifications

• Well organized, analytical and self-confident person.
• Solid experience in developing, implementing, and validating data management systems and Electronic Data Capture (EDC).
• Strong communication skills and interpersonal skills, ability to coach and mentor.
• Knowledgeable in GCP standards, FDA and ICH guidelines, and recommended CDM Best Practices.
• Hands-on extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.
• Able to work independently, as well as part of a team.
  
  

Posting Country

US - United States