What are the responsibilities and job description for the Associate Director, Clinical Data Management position at Latigo Bio?
Title: Associate Director, Clinical Data Management
Location: Thousand Oaks, CA or San Francisco, CA
Company Description:
Latigo Biotherapeutics is a private, early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes. Our mission is the development of novel therapies that transform the lives of patients. The company is headquartered in Thousand Oaks, CA and has a highly successful management team as well as an experienced Board of Directors. At Latigo, we value science, patient-focus, and innovation.
Postion Description:
Latigo is seeking an experienced Associate Director, Clinical Data Management to lead and oversee CDM activities across multiple trials within a clinical program. This position will contribute to ensuring the quality and integrity of the clinical data generated from Latigo Bio sponsored clinical trials.
The successful candidate will manage and collaborate with data management vendors effectively to ensure the timely delivery of clinical data that have completed study-specific review requirements. They will review data management specific plans and database specifications thoroughly to exercise a built-in quality approach. They will 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 program.
This individual will also work collaboratively with other internal and external clinical study team members across Clinical Operations, Biostatistics, Clinical Development and Translational Science.
Primary Responsibilities:
• Direct, manage and oversee CROs/vendors in clinical data management on clinical trials within assigned program.
• Oversee the data management activities and deliverables for studies within their assigned program to ensure quality, efficiency and consistency.
• Responsible for establishing and executing timelines for data management deliverables for clinical trials within the assigned program.
• Perform detailed reviews of data management specific plans and database specifications to ensure a built-in quality approach.
• Serve as the internal point of contact for Data Management with cross-functional team members, both internal and external, on clinical trials within their assigned program to ensure on-time quality deliverables per overall study timelines.
• 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.
• Review contracts, work orders and invoices with respect to Data Management activities within the assigned program.
• 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.
• Oversee vendor data reconciliation (i.e. central laboratory data, SAE) to include quality control and timely review of queries.
• Implement process and lead the creation of data review plans for internal cross-functional clinical data review activities.
• Ensure execution and completion of required data management deliverables from CRF design through final database lock.
• Oversee EDC user administration and access for assigned studies.
• Participate in the creation of SOPs that are necessary for internal Clinical Data Management activities.
• Maintain internal data management study level documentation in audit ready status, as applicable.
• Drive gap analyses to address critical issues and promote continuous improvement in Data Management.
• Perform other duties as requested.
Qualifications and Requirements:
• Bachelor’s degree required, at a minimum.
• 8 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.
• Great attention to detail with excellent interpersonal, organizational, written and verbal communication skills.
• Phase 1 through 3 clinical trial experience.
• 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.
• Experience working in an outsourced clinical data management model.
• Experience with eTMF systems and inspection readiness.
Salary ranges from $165,000 to $195,000
Salary : $165,000 - $195,000
