Clinical Data Manager

Worldcare clinical

Essential Functions

Review and assure the quality, integrity, accuracy, and completeness of clinical trial data based on project specific guidelines.

Develop and maintain a library of effective data quality checks.

Review data exports and reports to identify, investigate, and reconcile data discrepancies with Clinical Operations staff and/or clients Data Managers.

Prepare, review, and upload appropriate Data Management documents to the Trial Master File

Perform thorough development testing of the datasets prior to release to production, inclusive of creating test scripts and execute testing as applicable.

Author Data Transfer specifications (DTS) for incoming and outgoing data files.

Collaborate effectively and build productive relationships across the global operations team.

Performs other job-related duties as assigned

Qualifications

3+ years of data management experience in the clinical trials industry

BS/BA degree or professional experience equivalent.

Demonstrated successful experience in all relevant clinical data management activities in a Pharmaceutical or CRO setting.

Working knowledge of clinical trial research, including FDA, GCP/ICH guidelines, GDPR, CDISC/SDTM standards and 21 CFR Part 11

Experience working with EDC systems, ., Medidata Rave or Oracle Inform

Familiarity with industry wide coding dictionaries such as MedDRA is a plus

Experience with relational databases and XML a plus

Excellent written and oral communication skills.

Excellent analytical and problem-solving skills

Ability to function independently.

Ability to prioritize and handle multiple tasks and projects concurrently

Experience : 3 - 9 Years

No. of Openings : 1

Education : B.A, B.Sc

Role : Clinical Data Manager

Industry Type : Hospitals / Medical / Healthcare Equipments

Gender : [ Male / Female ]

Job Country : India