Director Clinical Data Systems
Proclinical is currently recruiting for a Director of Clinical Data Systems with a leading biotechnology company located in Boston, MA. As the Clinical Data Systems Director, you will lead and organize the clinical data management technology systems (ePRO, eConsent, IRT, EDC, etc) strategy, in collaboration with global clinical development and preferred strategic providers, to support the timely and efficient delivery of clinical data with high quality and within an allocated budget.
- Drive the clinical data collection and delivery strategy to ensure timely, quality data in alignment with clinical development needs and industry data standards.
- Collaborates with Clinical Development, Digital, Quality and Quality Systems to asses and identify new technologies to be utilized and implemented in support of the clinical trials. provide strategic oversight of clinical data deliverables including design and implementation of clinical data capture tools, data processing, validation and data quality
- 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 data management support of clinical development programs.
- Provide technical oversight at a study or program level for clinical data capture (e.g. ePRO, eConsent, Medidata Safety Gateway, etc.) and other technologies
- Provide validation support for tools utilized to support visual analytics or data status reporting
- Support and perform user account and administration across multiple technologies such EDC, IRT and Patient Portals
- Drives technology improvement and innovation to enhance clinical data capture, management and quality
- Collaborates with Quality Systems, Quality and Digital to perform vendor assessments and qualifications of clinical trial collection systems for compliance with regulatory requirements
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.
- Bachelor's Degree in computer science or a science-based subject; or Bachelor's Degree outside of computer science or a science-based subject with 12+ years' clinical data management experience in industry.
- 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.
If you are having difficulty in applying or if you have any questions, please contact Felix Hook at (+1) 646-367-2617 or email@example.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.