Associate Director, Clinical Data Management

Summit Therapeutics-posted 3 months ago
$165,500 - $195,000/Yr
Full-time • Senior
Princeton, NJ
Chemical Manufacturing
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Summit is seeking an experienced Associate Director, Clinical Data Management to support the company's research and development efforts in creating high-value therapeutics. The Associate Director will independently lead the data management components of clinical trials, ranging from small early-phase to large global and late-phase programs. This role involves directing the planning, implementation, and overall execution of clinical trial data management activities, including CRF/eCRF design, database development, validation programming, data review, discrepancy management, and database lock. The position also includes managing data management staff, Contract Research Organizations (CROs), and service providers to ensure accurate, efficient, and complete data collection for clinical trials.

  • Provide expertise and contribute to the strategy and development of the Clinical Data Management Portfolios to ensure data quality in support of clinical study data milestones and deliverables
  • Lead and support establishment of systems and processes to help ensure clinical data security, integrity, and long-term goals of the business function, in alignment with company priorities
  • Lead the data management of overall drug development process with early and late phase clinical trials in large or complex development program(s)
  • Provide technical expertise to develop and implement clinical data standards, data management plans, data transfer agreements, and data flow processes to ensure timely and quality data delivery for analysis purpose
  • Oversee the process to identify, evaluate and select CROs, vendors and technology for CDM activities
  • Lead, design and/or oversee eCRF design, eCRF specifications, eCRF completion guidelines, annotated CRFs, User Acceptance Testing, query logic, edit checks, data query resolution, SAE reconciliation between clinical and pharmacovigilance databases, vendor data reconciliation & cleaning, data migration and database closeout for clinical trials
  • Represent Data Management and promote productive collaboration with other functions (e.g., Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Translational Science, Project Management, Regulatory, QA, and IT) to ensure proper alignment around data management activities & deliverables, operational excellence, compliance with regulations, policies, procedures, and clinical objectives
  • Support cross functional teams and studies to handle data management questions, troubleshoot, help resolve issues and mitigate risks
  • Work with the Director of Clinical Data Science (CDS) to enhance efficiency, optimize costs, and drive excellence
  • Work with the Director of Clinical Data Science to establish CDM processes and procedures including SOPs to ensure highest data quality/integrity/security and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices
  • Lead clinical data management activities during regulatory audits, ensuring compliance with industry standards and regulations, and providing expert input throughout the audit process
  • Manage departmental budget and execute resource planning across multiple projects
  • Provide oversight and guidance, as well as establish key performance metrics with CROs to ensure the highest data quality/integrity and regulatory compliance
  • Accommodate ad hoc data requests between clinical team members, scientists, and vendors to support data cleaning, data entry requirements and exploratory data review if needed
  • Use scientific and drug development knowledge to anticipate and mitigate data management-related challenges during clinical trial execution
  • Review and contribute to clinical protocols and amendments, study manuals, and other study conduct related clinical documents; review clinical data according to these documents
  • Perform all other duties as assigned.
  • Bachelor's degree in Life Sciences, Computer Science, or relevant field of study; or equivalent practical experience
  • A minimum of 10+ years of Clinical Data Management experience (oncology experience highly desirable) in biotechnology or pharmaceutical industry with excellent understanding of late phase clinical drug development processes required
  • Experience with various data collection and Electronic Data Capture (EDC) systems and understanding of the MedDRA and WHODRUG coding processes
  • Strong track record of line management and supervisory experience of CDM staff, shown leadership skills to lead and inspire CDM staff including consultants
  • Excellent interpersonal, communication, and leadership skills
  • Consistent, detail oriented, communicative, dedicated to do a job well done
  • CRO and vendor oversight experience preferred
  • Strong knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
  • Experience in oncology clinical trials
  • Familiarity with regulatory audit processes
  • Experience in managing departmental budgets and resource planning.
  • 401k
  • health insurance
  • dental insurance
  • vision insurance
  • paid holidays
  • paid volunteer time
  • tuition reimbursement
  • professional development
  • flexible scheduling
  • employee stock purchase plan
  • life insurance
  • mental health days
  • wellness programs
  • gym membership
  • sign on bonus
  • performance bonus
  • stock options
  • unlimited PTO.
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