Executive Director, Data Management

Responsibilities

• Provide clinical data management oversight of outsourced clinical trials for phase I-IV studies including: project management, vendor management, coordination of internal reviews, and approval of deliverables.
• Lead efforts to develop internal expertise in order to increase internal DM activities across all studies.
• Introduce risk-based quality management and develop plan for implementation across programs. Coordinate with other functions as applicable.
• Act as primary liaison with CROs, third party data vendors, and EDC vendors
• Participate in vendor governance meetings and collaborate with Clinical Business Operations in creating outsourcing
• Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed.
• Primary reviewer for eCRFs, eCCGs, and Data Management Plans.
• Oversee database design and production, ensuring that the CRO/vendor meets the highest quality following SMPO standards
• Oversee report specification development as well as plan for programming across studies for patient profiles, QC listings and study oversight.
• Accountable for external data vendor documentation, management, and reconciliation.
• Management, training and mentoring responsibilities for internal data management team members.
• Key contributor to the strategic oversight of clinical programs and individual SMP Oncology sponsored trials.
• Facilitate departmental process improvement and integration of technology.
• Perform other duties as assigned.

Qualifications

• Highly developed mastery of complex clinical trial design issues in all phases of clinical development with a minimum of 10 years increasing responsible experience in clinical trial management, as well as LEAD clinical data management experience.
• Thorough working knowledge and understanding of Good Clinical Practices and ICH Guidelines and other applicable international regulations.
• Knowledge of Risk Based Quality Management across clinical trial
• Participate in NDA as key contributor for Data Management organization
• Lead an organization as key contributor through both FDA and EMA inspection
• Record of successfully completed clinical trials in all phases and multiple therapeutic areas as well as extensive CRO oversight.
• Ability to provide motivational leadership to the organization and improve its performance through the adoption of novel approaches to data management’s collaboration with other functions
• Demonstrated proficiency managing the lifecycle of clinical data projects.
• Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes.
• Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management.
• Ability to see ahead clearly and anticipate future consequences and trends accurately.
• Demonstrated track record of leading by example and leading others in problem solving and finding creative solutions based on sound judgment.
• Strong track record of attracting and developing data management, serving as a visible and engaging leader.

The base salary hiring range for this position is expected to be $227,300 to $307,200 annually. The base salary offered is negotiable and potentially exceeds the hiring range depending on factors such as the candidate’s relevant knowledge, skills, training, certifications and industry-based experience for the role. Our total rewards package also includes the opportunity for merit-based salary increases, short and long-term incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances. Our robust time-off policy includes accrual of 15 vacation days in first year, 13 paid holidays plus additional time off for a shut-down period during the last week of December, access to sick time and our tuition reimbursement program.