Develops moderate specifications for technical data management processes and systems. Tests and supports
systems for use on customer projects. Works on a project team and complies with all Standard Operating
Procedures (SOPs)/Work Instructions (WIs), regulatory guidelines and directives, and study specific plans
pertaining to these activities.
1. Prepares input for, and participates in proposal bid defense meetings.
2. Acts as Subject Matter Expert (SME) for designated systems/databases used by Data Management (DM)such as
Oracle Clinical and Rave. Works with DM staff to ensure that processes in relation to systems/databases are
consistent and that best practices are developed and maintained globally. Consults with customers and internal
INC functional areas as a subject matter expert, including IT and Helpdesk to ensure the designated systems are
properly configured and supported.
3. Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).
4. Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned
5. Participates in internal, customer and third-party meetings.
6. Participates in internal/external audits.
7. Develops User Test Plans for data entry screens, electronic edit checks, data listings, import/export programs and
8. Prepares test data for data entry screens and edit checks.
9. Coordinates and supports release of tested clinical data databases to the production environment.
10. Develops and/or delivers:
a. eCRF training for CRAs and site staff ;
b. applicable data management departmental training related to technical processes and systems;
c. other project specific training.
11. Develops and maintains CRF and eCRF Completion Guidelines (in consultation with clinical/customer team).
12. Develops specifications for listings and summaries (other than for statistical reporting requirements) from CRF
databases and external data sources. Reviews output to specification prior to distribution.
13. Designs eCRF entry screens and associated eCRF visit structure, indexing and version control.
14. Reviews :
a. designs for CRF pages and eCRF entry screens and associated CRF /eCRF visit structures, indexing and
version control, coordinating with team members responsible for the associated database design;
b. Data Entry guidelines;
c. configurations of CRF WorkManager;
d. SAS Mapping (from CDMS Databases)
15. Maintains documentation on an ongoing basis and ensures that all filing is up to date.
16. Participates in the development of departmental technologies, SOPs, processes, and procedures.
17. Trains and mentors data management staff.
18. Maintains proficiency in Data Management systems and processes through regular training and/or attendance at
19. Networks with colleagues for new and/or repeat business.
20. Represents Company at professional meetings or seminars.
21. Participates in the interview process for new recruits.
Performs other work related duties as assigned. Minimal travel may be required (up to 25%).
Skills & Attributes
BA/BS in the biological sciences or related disciplines in the natural science/health care field, moderate clinical data
management experience, including specifyin, testing, and support data management systems or an equivalent
combination of education and experience. Experience Clinical Data Management practices and relational database
management software systems. Contract Research Organization (CRO) experience preferred. Direct exposure to
Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good
Clinical Practices. Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
Effective oral and written communication skills. Good organizational, planning, and time management skills with
the ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to
change, to work independently, as well as part of a multi-disciplinary team. Ability to make effective decisions and
manage multiple priorities in a highly dynamic environment.
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.
INC Research is an EEO, M/F/D/V and a drug-free workplace. INC Research voluntarily participates in the federal E-Verify work authorization program.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to email@example.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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INC Research - 14 months ago
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