Clinical Data Management Associate II

Bioclinica Imaging- Neuro CDM

Clario is a 50+ year old company that delivers industry leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what’s possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence. 

What we offer: 

• Competitive compensation 
• Medical, dental, and vision insurance beginning Day 1 of employment 
• Flexible work schedules 
• Attractive PTO plan

• Engaging employee programs 
• Remote working 

 

What you'll be doing: 

Responsible for reviewing and evaluating clinical data generated from the imaging portion of sponsor clinical trials conducted in various therapeutic areas, providing accurate, timely, and consistent clinical data to client organizations and internal staff to support business objectives.  Resource defines and directs the data management workflow for assigned projects, ensuring all necessary data quality control measures are in place.

Primary Responsibilities

Ensures clinical trial databases meet project requirements by:

• Reviewing documentation and requirements for new projects and anticipating impact to Data Management (DM) standards/processes
• Collaborating with appropriate project teams as needed to stay abreast of and changes that could affect data collection, cleaning and/or transfers

Ensures the plan for data management is properly executed by:

• Understanding the requirements for study implementation and data collection
• Defining, running, and reviewing edit checks and resolving discrepant data
• Maintaining organized, complete, and up-to-date study documentation
• Creating or reviewing Transmittal Forms for a study, ensuring consistency with existing standards
• Keeping supervisor informed of project status

Ensures the accuracy and consistency of clinical databases by:

• Reviewing data and identifying errors/inconsistencies
• Developing study data specifications, including data transfer specifications, system configuration specifications, and data validations.
• Collaborating with appropriate project team to resolve data issues
• Tracking outstanding issues and following-up until resolution
• Preparing and validating ad hoc data listings as necessary
• Ensuring that system bugs and needs for enhancements are reported to the applicable Product Manager and that any stop-gap programming is approved

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by

• Adhering to department processes and standards
• 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 department

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 year’s experience in comparable position within the pharmaceutical, biotech or CRO industry
• Working knowledge of relational database organization and validation
• 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 le