Clinical Data Manager at Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
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 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
Requirements: Master's degree in Statistics, Biostatistics, Public Health, or related field
Minimum of eight (3) 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.
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
Requirements: Master's degree in Statistics, Biostatistics, Public Health, or related field
Minimum of eight (3) 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.