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 client’s 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

• Type of Job

  Full Time

• Work Location Type

  Work from Office