Clinical Data Manager is responsible for reviewing and evaluating clinical data generated from the imaging portion of sponsor clinical trials conducted in various therapeutic areas.
Performing all data management deliverables for assigned studies
Attending and participating in client meetings as requested
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, including TF design, database structure, specifications, and obtaining and providing 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
Secondary Responsibilities
Maintains Quality Service and Departmental Standards by:
Adhering to all Bioclinica Clinical Data Management (CDM) procedures, policies, and work instructions
Reading, understanding and adhering to applicable Standard Operating Procedures (SOPs)
Assisting in establishing and enforcing departmental standards
Participating in the review and updating of company SOPs related to DM Services
Contributes to team effort by:
Working with internal staff to resolve issues
Exploring new opportunities to add value to the organization
Helping others to achieve results
Performing other duties as assigned
Maintains Technical and Industry Knowledge by:
Attending and participating in applicable company-sponsored training
Qualifications:
Education:
Bachelor's degree in Computer Science, Life Sciences or related field preferred, or equivalent experience required
Experience:
1+ 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
Additional skill set:
Ability to work independently in a group setting; ability to adjust to changing priorities
Excellent attention to detail
Strong interpersonal and communication skills, both verbal and written
Strong documentation and organizational skills
Ability to project and maintain a professional and positive attitude
Working conditions:
Travel: 0-15%
Lifting: 0-25lbs
Other: Computer work for long periods of time
EEO Statement
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic
