Job Opportunity
The Senior Clinical Data Team Lead will play a pivotal role in leading and contributing to data management activities in support of clinical studies across all stages of drug development.
Key Responsibilities
* Lead study data management activities, including review of electronic Case Report Form (eCRF) content and edit check specifications
* Oversee database build activities, including cross-functional review and user acceptance testing
* Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
* Oversight of database lock activities and ultimate archiving of study data
* Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; Contract Research Organizations (CROs), central and local laboratories, and other vendors
* Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
* Review CRO data management plans, CRF completion guidelines, external data transfer specifications, and other study documentation
* Contribute to the development and implementation of department workflows and infrastructure strategy that reflects data collection standards, consistent with industry best practice and regulation
* Represent data management and effectively communicate requirements, strategy, timelines, and deliverables at internal cross-functional team meetings and meetings with external vendors
* Participate in the training of external vendors and site staff
* Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
* Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
* Support Good Clinical Practice (GCP) inspection readiness
Required Skills and Qualifications
* Strong leadership and project management skills
* Excellent communication and collaboration skills
* Ability to analyze complex data sets and identify trends
* Knowledge of clinical trials regulations and industry best practices
* Experience working with electronic data capture systems and vendor-managed databases
* Ability to work in a fast-paced environment and prioritize multiple tasks and deadlines
Benefits
As a member of our team, you will have the opportunity to work on challenging projects, develop your skills and expertise, and contribute to the success of our organization. You will also have access to a range of benefits, including professional development opportunities, flexible work arrangements, and a comprehensive compensation package.
Others
If you are a motivated and detail-oriented individual with a passion for data management, we encourage you to apply for this exciting opportunity. We look forward to hearing from you.