The Director, Clinical Data Management is responsible for managing, leading, and overseeing all Clinical Data Management (CDM) planning and operational activities to meet corporate goals, budgets, and timelines. This includes but is not limited to vendor qualification and selection, budget planning and work closely internally with appropriate legal contracts group on all contract negotiations, development of corporate data standards, and training and oversight for all CDM services from study start-up through study close-out, final reporting, and archiving. The Director will be responsible for staffing and resourcing the CDM group appropriately. Additionally, the Director will supervise, manage, and lead the design, implementation and ongoing practices of clinical DM processes with internal study resources and/or vendors.
Serves as Clinical Data Management Project Manager by providing leadership and management of data management activities. Directs data management activities according to quality standards, regulatory requirements and ensures adherence to project budget from study start up through archival in support of key development programs.
Directs and ensures all applicable data management databases are developed, validated, and meeting AnaptysBio's business requirements.
Works in collaboration with Quality Assurance and other functional groups to develop and update data management standard processes and procedures in accordance with CFR, GCP, ICH Guidelines and GCDMP, FDA regulations, CDISC and FDA submission standards and best practices. Maintains currency, including regulatory expectations.
Contributes to definition and setting of both strategy based on Senior Management's input and operations for clinical systems and data standards. Provides business process and technical direction to facilitate adoption and use of technologies for Data Management and trial management.
Evaluates Data Management outsourced activities to ensure efficiency and regulatory compliance. Provides study teams with recommendations on selecting Data Management vendors during selection process.
Formulate short-term and long-term strategies to improve DM efficiencies.
Cultivate effective and productive working relationships with colleagues, subordinates, vendors, and management as well as solve problems and escalate issues with proposed solutions to Senior Management as needed.
Accountable for hands-on management of trials and resources while maintaining a high level of data quality by adhering to corporate, industry and regulatory agency standard.
Educate clinical team members as needed regarding DM processes, workflow, and data standards that may have a direct impact on their work.
Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required.
Reviews and or develops standard operating procedures (SOP) and work instructions (WI) for data management department and participate in cross functional SOP and WI document review.
Perform other related duties as required and assigned.
Knowledge and Competencies
Effective communication and interpersonal skills.
Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well.
Self-motivated, independent, and results-oriented.
Excellent organizational and problem solving skills with the capacity to organize assignments and work within deadlines.
Highly attentive to details.
Position may require occasional evening and/or weekend commitment.
Position may require occasional domestic and international travel.
Education & Experience
Bachelor's or Master's degree or an equivalent combination of education and work experience, 10+ years of progressive CDM experience in biotech and/or pharmaceutical/drug development.
Global experience is highly preferred.
Experience to work effectively in a smaller company environment.
Experience in a hands-on early development role within a small organization is a plus.
Demonstrated ability to handle a high volume of highly complex tasks within a given timeline.
Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.