About Codera
Codera is a Tang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.
Position Summary
The Associate Director, Data Management supports the Data Management (DM) department and all clinical development programs. This individual is responsible for Electronic Data Capture (EDC) vendor oversight, project timeline management, clinical database setup through closeout, creation of data management documents, data metrics reporting, and data cleaning activities.
Essential Duties and Responsibilities
- Act as the data management lead for one or more clinical studies including responsibility for all data management and back-end activities from database start-up through database lock
- Establish and oversee partnerships with DM vendors and other external partners
- Ensure clinical databases and external data files are designed in a standard, accurate, complete, and consistent format to produce datasets that are conducive to analysis and regulatory submission
- Oversee data management vendors with respect to key performance indicators, metrics, program level deliverables, and timelines
- Review and provide feedback to the clinical team on study documents, including clinical monitoring plans, statistical analysis plans, vendor specifications, and informed consent
- Review protocols for all data management activities to ensure data is properly captured via CRF design and data requirements
- Coordinate and participate in the review of clinical data, tables/listings/figures (TLF) analysis, and patient profiles for data consistency and accuracy
- Ensure that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis, including raw datasets and annotated CRFs
- Ensure data management project documentation is in an audit-ready format
- Oversee the building, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements
- Oversee the generation of key documents such as data validation specifications, manual data review guidelines, data management plans, data cut plans, etc.
- Work closely with statistics and programming to ensure high-quality data output including data cleaning/validation, SAS listings review, TLF dry runs, etc.
- Develop, track, analyze, and report internal data management performance metrics
- Lead computer system development initiatives including database integration, data sharing, access, and storage
- Support other technology-based initiatives such as safety database and CTMS implementation
- Contribute to back-end project budget/resource planning, re-forecasting, program milestones and CPM, and clinical operation management
- Provide leadership, training, and support to data managers
- Communicate and escalate project issues involving processes, timelines, resourcing, performance, etc. and establish appropriate courses of action with senior management
- Assist in the preparation and support of clinical documentation for IND and NDA submissions as appropriate
- Direct the activities of the data management team to complete project deliverables on schedule and per quality standards and requirements from study start-up through archival
- Assist with the development of SOPs and specific quality processes and procedures for data management
- Ensure data management activities are conducted in accordance with GCP, internal SOPs, and all regulatory requirements
- Define department staffing needs and see they are met through the hiring of full-time employees or contract staff
- Assist with departmental performance evaluations, goal setting, career development, and growth
- Ensure all study specific training is kept up to date and documented for the department
Qualifications
- Bachelor’s Degree required
- Minimum 10 years of clinical data management experience in biotechnology or pharmaceutical industry required
- Advanced knowledge of data management processes and systems
- Solid understanding of clinical drug development processes
- Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills
- Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment
- Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities
- Excellent organizational skills with the ability to manage staff, projects, resources, timelines, and budgets
- Travel requirements include travel domestically and/or internationally up to 20%
Codera, LLC is an equal opportunity employer. Codera, LLC participates in E-verify.
