Senior Manager, Clinical Data Management

Position Description

Latigo is seeking a Senior Manager of Clinical Data Management to lead and oversee data management activities for assigned clinical studies, which includes, but is not limited to: CRF design and development, CRF standardization, ongoing data review and cleaning, rolling/interim/final database locks, and clinical data archival. They will work collaboratively with other internal and external clinical study team members across Clinical Operations, Biostatistics, Clinical Development and Translational Science. They shall be adept at utilizing and managing EDC systems, managing clinical data workflows and processes, and ensuring clinical trial data integrity and quality in their assigned studies to ensure high quality data in support of analysis for regulatory submissions, safety reporting and publications.

Essential Duties And Responsibilities

• Manage and oversee CROs/vendors in clinical data management on clinical trials within assigned program.
• Oversee the data management activities and deliverables from EDC build to final database lock and their timelines for assigned studies to ensure quality, efficiency and consistency.
• Perform detailed reviews of data management specific plans and database specifications to ensure a built-in quality approach.
• Perform User Acceptance Testing (UAT) on EDC, IRT and eCOA systems.
• Develop study metrics reports and other reports as needed.
• Work with vendors to set up and review data transfer specifications.
• Oversee vendor data reconciliation (i.e. central laboratory data, SAE) to include quality control and timely review of queries.
• Lead the creation of data review plans for internal cross-functional clinical data review activities.
• Oversee EDC user administration and access for assigned studies.
• Collaborate and communicate regularly with internal and external team members across other clinical trials and programs for consistency and standardization across programs to promote increasing efficiency.
• Proactively identify potential issues affecting timeline, milestones, or deliverables, and propose strategies to mitigate or resolve.
• Direct the development of CRFs and database design with cross-functional input and adherence to CDASH/CDISC standards and standards developed internally at Latigo Bio.
• Participate in the creation of SOPs that are necessary for internal Clinical Data Management activities.
• QC filing of data management documentation in the electronic Trial Master File (eTMF).
• Maintain internal data management study level documentation in audit ready status, as applicable.
• Perform other duties as requested.
  
  

Preferred Education & Experience

• Bachelor’s degree required, at a minimum.
• 7 years of relevant industry experience in clinical data management.
• Self-motivated and highly flexible individual with a proven track record of successfully managing multiple tasks and priorities within a fast-paced environment with minimal oversight.
• Excellent project management skills.
• Great attention to detail with excellent interpersonal, organizational, written and verbal communication skills.
• Proficiency in EDC systems (i.e. Medidata Rave) and other integrated clinical systems (e.g., IxRS/IRT).
• Working knowledge of ICH GCP and other regulatory guidance documents.
• Working knowledge of CDISC/CDASH, GCDMP and other clinical data standards.