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.

Primary Responsibilities

Ensures clinical trial databases meet project requirements by:

• 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 Clario 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

Clario is an equal opportunity employer. Clario 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