Associate Clinical Data Reviewer
1 day ago
At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.
We are growing our operations in India, with remote working opportunities as well as career openings in our Bangalore, Pondicherry and Mysore locations.
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
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
Delivery, Issue/Risk Management, Learning Agility, Sponsor/Internal Feedback, Task Management, Team Player/ Contributor
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