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Clinical Data Manager I
Major Responsibilities:
Ensures clinical trial databases meet project requirements by:
- Attending and participating in sponsor meetings
- Managing all data management deliverables for assigned studies
Ensures the plan for data management is properly executed by:
- Understanding the requirements for study implementation and data collection
- Collaborating with project team to develop study-specific edit check criteria
- Defining, running, and reviewing edit checks and resolving discrepant data
- Maintaining organized, complete, and up-to-date study documentation
- Performing study setup, specifications, and obtaining approvals as needed
- Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors).
- Keeping supervisor informed of project status
Ensures the accuracy and consistency of clinical databases by:
- Reviewing data and identifying errors/inconsistencies
- Collaborating with appropriate project team to resolve data issues
- Tracking outstanding issues and following-up until resolution
- Ensuring accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines
Qualifications:
Education
- Bachelor’s degree in Computer Science, Life Sciences, or related field preferred, or equivalent experience required
Experience
- 1 - 2 years’ experience in comparable position within the pharmaceutical, biotech or CRO industry recommended
- Working knowledge of relational database organization and validation
- Familiarity with SAS desirable
- Experience working with office productivity tools including Word, Excel and Access preferred
- Understanding of clinical trial terminology desirable
- Proven ability in problem solving
Successful candidates must comply with COVID-19 Workplace Safety mandate requirements
Allows remote work within the United States
Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.
