Senior Director Clinical Data Management #2593

You will:

• Operate as an expert strategic and thought leader for clinical data management processes and infrastructure to inform and accelerate GRAIL product development.
• Develop and lead a highly functional and scalable CDM organization, including formulating CDM strategy, operations, infrastructure, and processes.
• Develop corporate and/or organizational policies and authorize their implementation, and ensure compliance with SOPs, GCP, ICH guidelines, and other established guidelines of national and international regulatory authorities.I
• Interact internally and externally with executive level management requiring negotiation of difficult mattersInfluence policy and decision making bodies both internally and externally
• Play a key role in corporate development of methods, techniques and evaluation criteria for projects, programs and people
• Works on significant and unique issues that require exercising independent judgment and developing/adapting methodology.
• Provides data management leadership in support of clinical trials and RWE studies.
• Development of strategy and implementation of innovative methods to capture regulatory-grade real-world data, ensuring integrity throughout the data lifecycle (e.g. acquisition, system integration, de-identification, transformation, mapping, natural language processing, technology enabled abstraction, etc.).
• Ensure that budgets, schedules, and performance requirements are established and met.
• Create formal networks with key decision makers and serve as external spokesperson for the organization Assist clinical data management audit and address audit findings

Your qualifications and background will include:

• 15+ years of experience in academia or industry with demonstrated experience and knowledge in data management with at least 5 years of managerial experience. Molecular diagnostics or pharmaceutical industry experience preferred.
• Bachelors degree required; advanced degree preferred. Additional coursework in management, real-world evidence generation, life sciences, public health, or related fields is strongly desired.
• Extensive experience in both team and project management, including demonstrated experience in overseeing CROs and third-party vendors, and experiences in managing and mentoring direct reports. The experiences of successfully building a CDM team and overseeing multiple clinical trials and RWE studies is strongly preferred.
• Deep knowledge of clinical trials and medical device and/or drug development processes. Experience working on study start up, database locks, analysis timepoints and study closeout.
• Solid understanding of regulatory requirements and information governance frameworks (e.g. ICH, GCP, HIPAA. GDPR).Outstanding verbal, writing, and presentation skills with a strong ability to influence and communicate effectively throughout all levels of the organization and externally.
• Experience working on studies under the purview of the FDA and MHRA is a plus.
• Experience managing data for real-world evidence programs, registries, or other post-marketing studies is preferred, and experience working on studies involving integration with Electronic Medical Records (EMRs) or other electronic data sources is strongly preferred.
• Prior experience with software systems development and integration, EDC programming/configuration, or APIs is a plus.