In your first year your goals will include but not limited to:

• Promote standardization, automation, innovation, process improvement, and technology enhancement in CDM and beyond to increase drug development efficiency.
• Support establishment of sound CDM processes including SOPs to ensure the highest data quality/integrity and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices.
• Provide program oversight for CDM activities including CRF/eCRF design, validation programming, discrepancy management, and database development and production.
• Ensure studies are executed on time, within budget, and in adherence to quality standards.
• Champion and lead the development and implementation of policies, standards, and process improvement initiatives.
• Ensure CROs, suppliers, and internal staff meet the highest quality standards per SOPs.
• Provide oversight and guidance, as well as establishing key performance metrics with CROs to ensure the highest data quality/integrity and regulatory compliance.
• Responsible for vendor and technology (e.g., EDC or IRT) evaluation, qualification, and selection.
• Use scientific and drug development knowledge to anticipate and mitigate data management-related challenges during clinical trial execution.
• Support strategic decision-making processes involving data management issues for ongoing clinical trials.
• Promote productive collaboration between Biometrics & Digital Science and other functions (e.g., Biomarker, Clinical Operations, Clinical Science, Regulatory Affairs, QA, and IT) and ensure proper alignment around data management results.
• Identify and implement solutions to global data management and EDC issues and concerns.
• Provide strong leadership and inspiration to CDM staff. Recruit, develop, and motivate robust talents.
• Work with the head of CDM for resource planning and budget forecasting. Provide input into budget, timelines, and resource needs for CDM with sound judgment and efficiency.

We’d love to hear from you if you possess the following:

• Bachelor’s or Masters degree in a scientific subject area.
• Minimum 12 years of CDM experience in a pharmaceutical/biotech or CRO setting with at least 8 years of line management experience; global/international experience a must.
• Sophisticated knowledge of CDM processes, EDC systems, database programming, quality management and technology advancements in the field of data management.
• In-depth knowledge of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines
• Extensive experience in designing, leading and championing cross-functional projects with internal partners and CROs.
• Understand Inspection Readiness and Regulatory considerations.
• Consistent track record of line management and supervisory experience of CDM staff, proven leadership skills to lead and inspire CDM staff including consultants.
• Outstanding problem-solving abilities and influencing/negotiation skills.
• Excellent interpersonal, communication, and leadership skills.
• Logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities.
• Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude.
• Willing to travel if required.
• Ability to prioritize workload and meet deadlines, demonstrate effective use of time and handle multiple priorities simultaneously.
• Capable of actively identifying project challenges and risks and proposing appropriate solutions to issues.