Senior Director, Clinical Data Management and Operations

6 days ago

Cambridge, Massachusetts, United States Leap Therapeutics Full time
Job Summary

Leap Therapeutics is seeking a highly experienced Senior Director, Clinical Data Management to lead our clinical data management function. This role will be responsible for the strategic leadership and functional management of all CDM deliverables in adherence to company SOPs and ICH/GCP.

Key Responsibilities
  • Strategic Leadership: Provide high-level expertise and guidance in data management to support clinical studies, promote standardization, automation, process improvement, and technical enhancement in CDM to improve efficiency.
  • Process Development: Lead in the establishment of CDM processes, including identifying, authoring SOPs and Work Instructions to ensure regulatory compliance, GCP, and ICH.
  • Project Management: Prepare budget forecasts and manage CDM budgets, timelines, and resources, collaborate with other functions to develop project/study timelines, and maintain internal data management timelines.
  • Vendor Management: Provide leadership and direction for outsourced activities, including quality control and budget, ensure data management deliverables meet/exceed project/study team expectations regarding quality, time, and cost, and data management documentation is filed/archived according to applicable company and regulatory requirements.
  • Quality Assurance: Ensure data management CROs and other third-party vendors comply with the protocol, external/internal procedural standards, GCP, applicable regulatory guidelines, company policies, SOPs, and other relevant guidelines.
  • Documentation: Review and contribute to clinical study-related documents from a data management perspective and approve DM-specific documents.
  • Database Management: Lead and oversee the design, creation, and perform Sponsor User Acceptance Testing (UAT) activities for clinical trial study database builds and any subsequent database modifications.
  • Data Review: Lead and drive the internal data review process in collaboration with the Leap study teams to ensure data quality, define the data listings needed in support of the data review, ensure all identified issues are documented appropriately and followed to resolution/completion.
  • Archival and Inspection Readiness: Ensure archival and inspection readiness of all Data Management Trial Master (TMF) documents.
  • Training and Development: Provide comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes, may train other personnel on data management-related items as needed.
  • Collaboration: Ensure coordination with Pharmacovigilance on serious adverse event reconciliation, work with medical coding (MedDRA, WHO Drug Global) to ensure coding is performed as per study timeline, and participate or assist in initiatives and in the development, review, implementation, and maintenance of processes and SOPs related to clinical data management activities.
  • Audit and Inspection Support: Participate in audits and inspections, may assist in performing a functional assessment of data management CROs/vendors.
  • Team Management: Manage a couple of data managers and/or contractors.
Requirements
  • Education: BA/BS in scientific or health-related field.
  • Experience: 12+ years data management experience in a pharmaceutical, biotechnology company, or a CRO.
  • Oncology Experience: Oncology experience is required.
  • Technical Skills: Significant experience of using data management methodologies and technologies, familiar with multiple EDC systems, experienced with CDISC data standards, in particular, CDASH and SDTM.
  • Project Management Skills: Demonstrated ability to manage multiple projects/studies, strong project management skills.
  • Regulatory Knowledge: Demonstrated understanding of regulations and guidelines, e.g., ICH, GCP, FDA, Privacy rules (HIPAA), etc.
  • Communication Skills: Ability to read, analyze, and interpret complex technical documents, effective problem-solving skills, experience using Microsoft Office applications, strong organizational skills, and the ability to prioritize tasks.

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