Associate Director/Director, Data Management

Codera; San Diego (CA); On-site; USD 160,000 - 230,000; Full time

Benefits offered by this job

Discretionary bonuses

Comprehensive benefits package

Professional development programs

Job summary

Codera is seeking a Director or Associate Director of Data Management to lead DM activities across clinical programs. The role oversees EDC vendor management, database setup through closeout, and data quality for regulatory submissions.

The ideal candidate has 10+ years in clinical data management, hands-on Medidata Rave experience, and strong leadership in a fast-paced biotech environment. Role may start consulting with potential for full-time employment.

Qualifications

• Bachelor's degree required with 10+ years in clinical data management in biotech/pharma.
• Advanced knowledge of data management processes and Medidata Rave.
• Strong understanding of clinical drug development and data workflows.

Responsibilities

• Lead data management for studies from startup through database lock.
• Oversee DM vendors and external partners with KPIs and timelines.
• Ensure datasets are analysis-ready for regulatory submissions.
• Review study documents and data management plans for quality.
• Coordinate data review, tables/listings/figures, and data consistency.

Skills

Data management leadership

EDC oversight

Project timeline management

Data cleaning

SAS listings review

Education

Bachelor's Degree

10+ years clinical data management

Tools

Medidata Rave

Data management systems

Job description

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 Director or 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.

The ideal candidate is open to starting on a consulting basis, with the potential to transition into a full-time, permanent position.

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 and vendor specifications
• 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, CRF completion guidelines, data access plan, data transfer agreements, 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 the setup of other systems such as the safety database and IRT
• Contribute to budget/resource planning, re-forecasting and program milestones
• Provide leadership, training, and support to data managers
• Communicate and elevate 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
• Assist with directing 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
• 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
• Advanced knowledge of setting up Clinical Databases in Medidata Rave
• 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%

The job description is not designed to cover orcontaina comprehensive list of activities,dutiesor responsibilities that arerequired. They may change, or new ones may be assigned at any time with or without notice.

The estimated annual base salary for this position is$160,000 - $230,000,commensuratewith experience and skills.

This role may be eligible fordiscretionarybonuses and other incentive programs.

Coderaprovidesa comprehensive benefits package designed to supportemployees' physical,mentaland financialhealthandincludeemployer sponsoredinsurance plansincludingmedical, dental and vision coverage;generous paid time off; retirement plan options andadditionalwellnessandprofessional developmentprograms

Coderaprovides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Coderaparticipatein E-Verify. All newly hired employeesare required tocomplete the E-Verify process as part of their employment eligibility verification.