Director Clinical Data Monitoring

Proclinical is currently recruiting for a Director of Clinical Data Monitoring with a global biotechnology company located in Cambridge, MA. As the Clinical Data Monitoring Director, you will lead and organize the initiative to develop and maintain the Clinical Data Central Monitoring strategy and governance in collaboration with clinical development and preferred strategic providers, to support timely and efficient delivery of clinical data with high quality and within an allocated budget.

Job Responsibilities:

• Drive the clinical data central monitoring and oversight strategy to ensure timely, quality data in alignment with clinical development needs and industry clinical data standards for central data monitoring processes and techniques.
• Develop key quality and risk indicators that support clinical data driven decision making and risk mitigation strategies.
• Collaborate with Clinical Development/Clinical Risk Management, Digital, Quality and Quality Systems to assess and identify new technologies to be utilized and implemented in support of clinical data central monitoring as well continue to assess and define the next-generation strategy and roadmap for central data monitoring and visualization.
• Assess and provide insight to current/ latest technologies and changes in regulatory environments, enabling a proactive approach and planning to meet future requirements and efficient study and clinical data management support of clinical development programs.
• Collaborate cross-functionally, across all clinical studies and therapeutic areas to define and utilize a clinical data central monitoring plan and strategy throughout a clinical trial lifecycle, from protocol development, study startup through database lock and protocol amendments using data analytics.
• Provide strategic oversight of clinical data management vendors utilizing central data central monitoring.
• Train, guide and support cross-functional team members across clinical development in the use of data visualization tools and techniques for central data monitoring; develop key templates, performance indications and metrics as it pertains to clinical data.
• Provide technical oversight at a study or program level for clinical data utilizing clinical data central monitoring technologies or tools.
• Drives technology improvement and innovation to enhance clinical data capture, management and quality; collaborate with clinical data management and clinical data standards to define and improve clinical data collection and data cleaning tools and processes.

Skills and Requirements:

• BS degree in Computer Science, Life Science or other technical field required; advanced degree desired.
• 10+ years of applicable informatics, systems and /or relevant drug development experience; global experience and experience in drug development strongly preferred.
• 8+ years of project management and leadership experience.
• Knowledge of general database programming and computing principles, common software products and technologies used in drug development.
• Ability to develop and evaluate business cases and effectively manage budgets.
• Thorough command of FDA and ICH GCP regulations and industry standards applicable to drug development systems.
• Knowledge of regulations and best practices related to computer system validation, electronic records and signatures and data privacy.
• Vendor management and oversight experience.

If you are having difficulty in applying or if you have any questions, please contact Felix Hook at (+1) 646-367-2617 or f.hook@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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