Job Summary
The Senior Clinical Data Associate will perform complex Case Report Form /electronic Case Report Form (CRF/eCRF) data review with increased independence and efficiency as compared to less experienced data management roles. This work will be performed in compliance with Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; and study specific plans and guidelines.
They will also perform essential functions which support the CRF database testing, as well as additional data management activities such as CRF/eCRF design, external data reconciliations, and review of database designs within an appropriate mentoring and training programand may provide training and work direction to less experienced data management staff as required.
They will also take responsibility for coordinating the workload/delivery of a small team of Clinical Data Associates (CDAs) under the direction of a Project Leader / Functional Team Leader / Manager.
Core Responsibilities
1. Oversees the work of other CDA’s as required. This may involve on-the-job training, scheduling of work, as well as ensuring the quality of work performed.
2. Provides support to the Project Leader / Functional Team Leader on a study as required. May involve soliciting support from and coordinating with other CDAs, taking full responsibilityfor an aspect of the study delivery, or producing study metrics reports.
3. Liaises with other groups such as Clinical Programming, Project Analysts, and Clinical Operations.
4. Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).
5. Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
6. Enters test data for data entry screens.
7. Enters test data for edit checks.
8. Performs review of discrepancy (edit check) output and validation listings based on data entered into the CRF database. Based on this review will issue Data Clarification Forms (DCFs) or apply self-evident corrections or other global rulings permitted in cases where DCF issue is not required, per the Clinical Data Validation Plan for the assigned projects.
9. Reviews draft DCFs, self evident corrections and the application of global rulings, proposed by less experienced Data Management staff.
10. Reviews draft DCFs raised by staff responsible for the coding of CRF terms for adverse events, medical history, and medications against medical coding dictionaries.
11. Issues DCFs to sites.
12. Takes receipt of, and reviews, DCFs that have been answered by sites. Where appropriate, edits the CRF database accordingly.
13. May code investigator terms for adverse events, medical history, and medications using medical coding dictionaries, designated software and electronic dictionaries. Tests such coding processes function correctly for each assigned project.
14. Ensures that data from external databases/datasets such as laboratory databases, or electronic diary datasets are consistent with data held on the CRF database. Uses the specified process to document and query any such discrepancies found with the appropriate party.
15. Ensures all Case Report Forms (CRFs) and Data Clarification Forms (DCFs) received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
16. Participates in internal meetings.
17. Participates in customer and third party meetings.
18. Participates in internal/external audits.
19. Trains and mentors less experienced data management staff.
20. May design, or review designs, for CRF pages and eCRF entry screens and associated CRF / eCRF visit structure, indexing and version control, co-coordinating with team members responsible for the associated database design.
21. Reviews
a) database design specifications - including configuration, data structures, annotated CRF production.; Note review of CDISC variable naming requirement will be delegated to Clinical Programmers
b) CRF and eCRF Completion Guidelines.
22. Trains project team in project specific requirements.
23. Resolves issues arising from quality control checks on listing output from database against CRFs and DCFs.
Skills & Attributes
- Degree educated in the biological sciences or related discipline
- Experience with Clinical Data Management practices and relational database management software systems
- Direct exposure to Oracle Clinical, RAVE, or Inform systems preferred
- Knowledge of medical terminology, clinical data and ICH/Good Clinical Practice
- Effective oral and written communication and presentation skills
- Good organizational, planning, and time management skills with the ability to multitask under tight deadlines
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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INC Research -
15 months ago
