Job Description

Responsibilities:

• Lead the design of data collection and management systems and initiate process improvements as needed.
• Establish goals, timelines, and deliverables for data management of trials, and oversee priorities and timelines for all data staff to provide cohesion across studies and ensure that data management support needs are aligned with program timelines for trials in the pipeline.
  Train, develop and conduct performance management for data management staff.
• Manage data management team members FTE and workload distribution.
  Develop and lead quality control and quality assurance efforts for clinical trial data.
• Participate in negotiation of contracts and approve master agreements and project SOW specifications and budgets. Oversee vendor/CRO performance.

Requirements:

• Master's degree in Statistics, Biostatistics, Public Health or related field.
• Minimum of eight (8) years of related experience, or PhD in Statistics or Biostatistics with minimum 1years experience.
• One (1) years of direct management experience.
• Familiarity with data management applications and database support requirements in a clinical trial setting.
• Familiarity with data management programming tasks.
• Experience with electronic data capture systems.
• Clinical study related experience.
• SAS, Stata or R programming experience.
• Medidata Rave experience.
• Redcap Experience.
• Knowledge of Medical Terminology, FDA requirements in clinical trials, GCP and ICH.
• Strong oral and written communication skills.

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