Updated: Yesterday
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002255
Syneos Health® is a fully integrated biopharmaceutical solutions organization, focused on accelerating customer success through clinical development, medical affairs, and commercial insights. The company operates across 110 countries with 29,000 employees and is committed to innovation and improving patient outcomes.
Maintain awareness of project contracts and scope of work.
Adhere to study-specific Clinical Data Management Plans (DMPs).
Receive and enter lab normal ranges.
Submit Clinical Database Management System (CDMS) access forms/spreadsheets.
Review and validate discrepancy outputs, applying queries or self-evident corrections as per Data Validation Specification (DVS).
Process Data Clarification Forms (DCFs) and edit Case Report Forms (CRFs) accordingly (for paper studies).
Perform internal quality control (QC) checks via database listing outputs.
Ensure all received CRFs and DCFs are filed correctly.
Serve as a backup for data entry in paper and hybrid studies.
Conduct pre-review and QC review of CRFs using an image system.
Perform data management quality reviews in Electronic Data Capture (EDC) studies.
Assist in project tracking and status report generation.
Participate in database finalization and transfer to sponsors.
Identify and track project milestones.
Create electronic storage media for EDC studies.
Attend internal meetings and audits as required.
File documentation in the Data Management Study File (DMSF).
Assist with study archival.
Maintain proficiency in DM systems and processes via training.
Understand coding processes, interim analysis, dry run, and data cuts.
BA/BS degree in biological sciences, natural science, or healthcare-related field.
1-2 years of experience in Clinical Data Management (CDM) preferred.
Experience in data cleaning, SAE, PK & PD, IVRS, lab data reconciliation.
Preferred experience with Inform EDC systems.
Knowledge of ICH-GCP and clinical data management practices.
Familiarity with medical terminology (preferred).
Strong proficiency in MS Windows, MS Word, MS Excel, and email applications.
Fast and accurate keyboarding skills.
Strong communication, presentation, and interpersonal skills.
Ability to multitask, work under deadlines, and adapt to change.
Strong organizational and time-management skills.
Ability to work independently and in a team.
Vaccines & Oncology
Minimal travel required (up to 25%).
Compliance with SOPs, corporate policies, and applicable regulations.
Participation in internal/external audits.
Company offers a diverse, inclusive, and growth-oriented work environment.
Worked on 94% of all FDA-approved novel drugs in the last 5 years.
Conducted 200+ studies across 73,000 sites with 675,000+ trial patients.
Encourages diversity and transferable skills.
Supports career development, recognition programs, and work-life balance.
Apply online or Join the Talent Network for future opportunities.
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