MMS
Posted 58 days agoVerified live 1d ago
Clinical Data Manager (India, Hybrid/Remote)
Brief overview
Remote
UndergradOr in progress
2+ yrsMinimum
5 H-1B approvalsDept. of Labor
Clinical Data ManagementElectronic Data Capture (EDC)eCRF DevelopmentCRF Completion GuidelinesEdit Check SpecificationsData Management Plan (DMP)Study Tracking and Metric ReportingData Validation and ReviewQuery Processing and ResolutionAdverse Event and Medication CodingSerious Adverse Event (SAE) ReconciliationDatabase Lock and Quality Control AuditsUser Acceptance Testing (UAT)Clinical TrialsPharmaceutical DevelopmentQuery and Discrepancy Management
About the company
MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
Visa sponsorship history
2 years sponsoring, last filed FY2025
Data powered by U.S. Department of Labor. This does not guarantee sponsorship for this specific role.5H-1B approved
83%approval rate
H-1B Petition ApprovalsVisas USCIS actually granted: the strongest sign the company sponsors.
20232
20242
20251
Job description
Summary
MMS is an award-winning, data-focused clinical research organization (CRO) recognized for its exceptional culture and employee retention rate. They are seeking a Clinical Data Manager to contribute to the development of electronic case report forms (eCRFs), study tracking, data validation, and user acceptance testing, among other responsibilities.
Responsibilities
- Contribute to developing eCRFs, CRF Completion Guidelines, Edit check specs, and DMP
- Contribute to study tracking and metric reports for use by the study team
- Contribute to CRF tracking and data entry, integration of external electronic data, data validation and review, query processing and resolution, adverse event and medication coding, SAE reconciliation, database lock and database QC audits
- Contribute to user acceptance testing (UAT) of EDC and integrated systems including executing of test plan and scripts
- Assist with preparation for training sites/users training on EDC applications, and UAT
- End user knowledge for study conduct activities including queries management, standard reporting and extracting data
- Learning to develop data entry screens, dynamics, edit checks and other EDC components
Skills
- Bachelor's Degree in a scientific, medical, or clinical discipline or related field is required
- 2-6 years of previous experience in clinical data management
- Experience in the pharmaceutical or CRO industry must
- Experience with query and discrepancy management required
- Effective problem-solving and data analysis skills
- Has a strong attention to detail
- Master's or PhD preferred
- Hands-on experience with clinical trials and pharmaceutical development preferred
Qualifications
Must Haves
- Bachelor's Degree in a scientific, medical, or clinical discipline or related field is required
- 2-6 years of previous experience in clinical data management
- Experience in the pharmaceutical or CRO industry must
- Experience with query and discrepancy management required
- Effective problem-solving and data analysis skills
- Has a strong attention to detail
Nice to Haves
- Master's or PhD preferred
- Hands-on experience with clinical trials and pharmaceutical development preferred
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