Director, Clinical Data Management

Brightech International - Somerset, NJ4.5

Full-timeEstimated: $110,000 - $150,000 a year
EducationSkills
  • 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.

MINIMUM REQUIREMENTS

  • 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

Experience:

  • Clinical Data Management: 6 years (Preferred)

Education:

  • Bachelor's (Required)

Location:

  • Somerset, NJ 08873 (Preferred)