Title: Clinical Data Associate
The main responsibilities:
- To manage and/or back all aspects of Data Management on a clinical trial from set-up, through conduct, to database lock, with the goal of attaining data quality adequate for analysis and regulatory submission.
- Work collaboratively with Clinical Data Coordinator, Clinical Data Manager and Project Management staff to encounter project deliverables and timelines for clinical data attainment, quality checking and reporting.
- Assist in the planning and application of Clinical Data Management processes. Lead and/or support the trial eCRF design and testing procedures for precise data collection.
- Prove a general understanding of each assigned protocol, critical tasks and milestones.
- Guarantee completeness, accuracy and consistency of routine clinical data and data structure.
- Lead and/or support the design and implementation of clinical data management processes including data entry, data quality checking, data transfer, reporting, archiving.
- Interact with study site coordinators, investigators and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner.
- Apply reports & data tools to track study progress to ensure timeliness and quality expectations are met. Identify, track, and resolve queries.
Qualifications and experience:
- Degree level (or higher) in a Biomedical Science (or equivalent).
- Experience in Clinical Data Management or related Clinical Research role is preferred.
- Excellent verbal and written communication skills.
- Excellent interpersonal skills.
- The ability to problem solve and have project leadership skills.
- Understanding of the Drug Development process.
- Extensive knowledge of web-based Electronic Data Capture (EDC) systems.
- An understanding of Post Marketing/PhIV/Medical Affairs/Observational studies advantageous.
- Work with minimal supervision.