Senior Clinical Data Acquisition Expert

Job description

1. Ensure eCRF is built according to the latest standards and best practices, including edit checks and applicable integrations (IWRS, CTMS, etc); translate protocol requirements into optimal data capture approaches; oversee eCRF build and updates by CRO or vendor to confirm quality.

2. Provide specifications for data models to be used for quality review and for final data model (SDTM or other); design mapping algorithms for non-standard conversions.

3. Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc) and compliant for Database lock.

4. Program, or oversee programming of, quality review checks and reports for use by Global Data Managers and other team members.

5. Ensure non-eCRF technologies for data capture (e.g., ePRO, safety reporting, coding, IWRS) are deployed as per requirements, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined.

6. Oversee development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-forpurpose data models and transfer intervals.

7. Develop and maintain working knowledge and expertise in programming languages utilized in data management (SAS, SQL, etc) and apply continuous learning as data management platforms evolve.

8. Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements.

9. Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, Clinical Data Tools such as LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml.

10. Support the development of standards and drive their implementation within the organization

Desired profile

Qualifications :

PRINCIPAL RELATIONSHIPS:
Contacts in the organization: Clinical trial team members, including Global Data Managers,and Statistical Programmers; Standards experts, eBIS system support staff, Data Delivery Leads. Contacts outside of the organization: CRO staff performing activities in support of a trial, ancillary vendor staff.

EDUCATION AND EXPERIENCE REQUIREMENTS:
Minimum of 3 Years of experience in data management (data review, database management, standards development, statistical or data management programming, CRF build, etc).

The following competencies are required: • Knowledge of protocol and current clinical drug development processes • Knowledgable of international guidelines regarding clinical trials end to end • Working knowledge of an eDC system, e.g. Medidata platform of tools, Clinbase eCOS, etc. • SAS programming skills or other analytical programming language • Working knowledge of reporting tools, e.g. Spotfire • Working knowledge of SDTM including Define.xml , CDASH, metadata and ADAM • Ability to work with cross-functional team interpreting data requirements. • Proven knowledge of good data management practices • Proven project management skills;

In addition, the following competencies are desired: • Vendor management oversight experience.