- Data Management
- Microsoft Project
- Clinical Trials
- Medical Terminology
- Provides support and oversight for Data Management team.
- Acts as primary liaison between sponsor and Brightech for Data Management.
- May provide oversight for Information Technology, Quality Assurance teams and assume a lead role for assigned activities.
- Collaborates with the client on study design, protocol development, CRF design, statistical planning and CSRs.
- Ensures project objectives meet quality acceptance criteria.
- Plans, implements, and manages operational and financial aspects of data management tasks for global and domestic projects.
- Responsible for establishing and maintaining study timelines and tracking timelines, management if resources.
- Identifies and manages team milestones and project risks.
- Ensures appropriate levels of resource management, support, and training are provided to designated staff.
- Provides leadership and support for cross-functional tasks, processes and training.
- Provides oversight and manage relationship with external vendors.
- Responsible for development of SOPs and guidance documents related to departmental and organizational functions.
- Provides input into budget proposals, client presentations.
- Pro-actively identifies potential challenges, risks and develop proposed solutions and/or contingency plan.
- Leads designated team meetings.
- Prepares and leads vendor audits as assigned.
- Performs additional tasks as assigned.
- BA/BS or above is required.
- At least 6-10 years experience in Clinical Data Management, with a minimum of 5 years as a clinical project manager with a pharmaceutical/biotech company or CRO preferred (or equivalent relevant training and professional experience.
- Experience in supervising people, project and team activities.
- Strong organizational skills and discretion with confidential information.
- Experience with field monitoring or Global trial experience is a plus.
- Strong knowledge of medical terminology and the clinical trial process is required.
- Good experience in EDC as well as good knowledge with SAS dataset structure.
- Strong Knowledge of GCP, ICH and ISO guidelines.
- Experience establishing and managing budgets is a plus.
- Leadership skills and a positive personality.
- Strong communication skills (written and verbal); MS Project and PowerPoint a plus.
Job Type: Full-time
- Clinical Data Management: 6 years (Preferred)
- Somerset, NJ 08873 (Preferred)