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 6 years experience.
Two (2) years of direct management experience
Familiarity with data management applications and database support requirements in a clinical trials 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, Skills, And Abilities
Knowledge of study design.
Knowledge of Medical Terminology, FDA requirements in clinical trials, GCP and ICH.
Efficient use of statistical programming languages
Experience in effectively managing vendor and internal customer relationships
Strong oral and written communication skills.
Demonstrated leadership and organizational skills.
Excellent oral presentation skills.
Excellent interpersonal skills.
Uses professional concepts to contribute to development of clients concepts and principles.
Achieves objectives in creative and effective ways
Primary Responsibilities
Provide expert data management leadership, and identify, implement and manage, through subordinate staff, the cost-effective data management support for the Client’s trial pipeline. Lead the design of data collection and management systems and initiate process improvements as needed.
Establish goals, timelines, and deliverables for data management of Client’s 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.
Seniority level
Director
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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