Clinical Data Management Specialist

Webosphere

5 years

0 Lacs

ahmedabad gujarat india

Posted:2 weeks ago| Platform:

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Skills Required

data management design report database tracking query biostatistics writing checks capture reconciliations imaging audits compliance gcp documentation reports metrics support development biotechnology medidata oracle communication coding sas

Work Mode

On-site

Job Type

Full Time

Job Description

Design, develop, and maintain Case Report Forms (CRFs) and Data Management Plans (DMPs)
Manage clinical trial data from study start-up through database lock, including CRF tracking, query resolution, and database maintenance
Ensure accurate and timely entry, review, and cleaning of clinical data in accordance with Good Clinical Data Management Practices (GCDMP)
Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs
Lead data review meetings and provide input on data issues, discrepancies, and risks
Develop edit checks and validation rules for Electronic Data Capture (EDC) systems
Coordinate with external vendors for data transfers, reconciliations (e.g., lab, imaging), and system integrations
Participate in audits and inspections to ensure compliance with SOPs, GCP, and regulatory guidelines (FDA, EMA, ICH)
Generate and maintain documentation including Data Review Reports, Data Transfer Specifications, and Metrics Reports
Support the development and implementation of CDM standard operating procedures and tools

Qualifications

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or a related field
2–5 years of experience in Clinical Data Management within a pharmaceutical, biotech, or CRO setting
Proficiency with EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva CDMS)
Strong understanding of GCDMP, ICH-GCP, and regulatory requirements
Excellent analytical, problem-solving, and organizational skills
Effective written and verbal communication abilities
Experience with coding dictionaries (MedDRA, WHODrug) is a plus
Familiarity with SAS or other statistical tools is an advantage

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