Description:
As a Principal Clinical Data Lead in our Clinical Data Management (CDM) division, you are responsible for independently ensuring the accuracy and timely delivery of clinical data for highly complex studies. You will also lead or contribute to the evolution of new concepts, technologies, and standards. Your role extends beyond technical expertise as you'll serve as a positive role model for peers, encouraging both technical and social skills. Your role involves performing various tasks to guarantee the accuracy, completeness, and compliance of data crucial for publications and regulatory submissions. Your involvement in crafting technical landscapes, business strategies, and healthcare environments through contributions to various initiatives is integral.
You will be responsible for:
- Collaborating with peers across the data management function and throughout the organization to identify, design and deliver appropriate data management solutions.
- Completing data management tasks, providing technical expertise, and coordinating project deliverables from Contract Research Organizations (CROs), Functional Service Providers (FSPs), and vendors on a timely basis.
- Innovating data collection methods and ensuring the development and delivery of medicines for our patients using critical thinking, strong collaboration and communication skills, and an ambitious mentality.
- Leading or overseeing study-specific study start-up tasks, including case report form (CRF) design, edit check creation, CRF completion guideline (CCG) creation, and user acceptance testing including leading process improvements and enhancements, as needed. Leading the development and maintenance of the data management plan (DMP).
Principal Clinical Data Lead (CDL)
- Leading data validation tasks for complex studies during maintenance and close-out, focusing on data integrity and quality metrics.
- Leading ongoing operational support for all activities during clinical trial conduct, including database migrations, ad-hoc report creation, maintenance of external data transfer documents, import/export agreements and data specifications, and support for database lock, archiving, and clinical coding activities.
- Ensuring all quality and compliance activities are complete, including medical coding, report generation, drug supply, other database integrations, and external data activities.
- Independently monitoring activities and project status for successful project deliverables according to the timeline while participating in initiatives to streamline data management processes.
You will need to have:
- A bachelor's degree in a scientific field or equivalent.
- Experience in clinical data management for 5 or 6+ years or proven experience.
- Thorough knowledge of the clinical data management and clinical development process, including regulatory submissions for various agencies (FDA, EU, etc.) and knowledge of CDASH, application of FAIR (Findable, Accessible, Interoperable, Reusable) principles, MedDRA/WHO-DD dictionary coding and versioning, with exposure to digital technology, and data visualization technology.
- Highly effective written and verbal communication skills are vital to interact with personnel at all levels within and outside the company.
- Strong organizational skills demonstrating the ability to work on multiple projects simultaneously while independently handling responsibilities with effective time management and impactful outcomes.
- Ability to independently solve complex, abstract problems in cross-functional business collaboration and independent projects while demonstrating proactive drive, sound decision-making, and attention to detail.
- Proficiency with technology associated with current and evolving data management practices, including electronic data capture and data aggregation, and with exposure to data visualization/analytics, automated data bots, machine learning/artificial intelligence-based process enhancements, etc.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.