Clinical Data Management Specialist
Company: Alvotech
Location: Bangalore, India / Stockholm, Sweden (Partially Remote)
Job Type: Full-Time | Remote
Experience: Typically 7+ Years (Clinical Data Management / Clinical Trials)
Qualification: Bachelor’s Degree or equivalent
Salary Range: Not Specified
Job Overview
Alvotech is seeking a Clinical Data Management Specialist to ensure high-quality, accurate, and reliable clinical trial data.
The Clinical Data Management Specialist will be responsible for end-to-end data management activities across the clinical study lifecycle, from study setup through database lock. The role involves working independently as well as collaboratively with cross-functional teams to ensure timely and compliant data delivery.
This position plays a key role in supporting clinical trials by ensuring data integrity, regulatory compliance, and readiness for statistical analysis and submissions.
Key Responsibilities
Clinical Data Management Operations
Manage end-to-end data management activities including study setup, conduct, and database lock.
Ensure adherence to study timelines, KPIs, and quality standards.
Oversee study start-up activities and data management deliverables.
EDC & eCRF Design
Design electronic Case Report Forms (eCRFs).
Set up and configure Electronic Data Capture (EDC) systems.
Develop validation check specifications and perform User Acceptance Testing (UAT).
Ensure proper integration between EDC and IWRS systems.
Data Handling & Reconciliation
Develop Data Transfer Agreements (DTAs).
Reconcile data from multiple sources including labs, safety databases, IRT, and ePRO systems.
Ensure consistency and accuracy of integrated clinical data.
Data Review & Query Management
Review clinical data for completeness and accuracy.
Generate, track, and resolve data queries.
Monitor CRF data entry and query backlogs.
Ensure readiness for database lock.
Vendor & Project Coordination
Communicate with project teams and external vendors.
Review Scope of Work (SOW) and ensure budget adherence.
Coordinate data management activities across stakeholders.
Documentation & Compliance
Maintain clinical data management documentation and working files.
Perform eTMF filing and quality control checks.
Ensure compliance with regulatory standards including GCP and 21 CFR Part 11.
Support audits and inspections.
Standards & Data Quality
Review SDTM implementation including aCRF annotations and mapping.
Ensure adherence to CDISC standards (CDASH, SDTM).
Maintain high standards of data quality and consistency.
Required Skills
Clinical Data Management Expertise
Strong experience in clinical data management across study lifecycle.
Experience managing complex clinical trials and datasets.
Understanding of clinical trial data workflows and processes.
Systems & Technical Knowledge
Experience with EDC systems such as Viedoc, Veeva EDC, and Medidata Rave.
Familiarity with IWRS and data integration systems.
Knowledge of SAS Enterprise Guide is an advantage.
Regulatory & Compliance Knowledge
Understanding of GCP, 21 CFR Part 11, and GCDMP guidelines.
Knowledge of European Medicines Agency guidelines on computerized systems.
Experience supporting audits and regulatory inspections.
Communication & Organization
Strong communication and interpersonal skills.
Excellent organizational and time management abilities.
Ability to work independently and manage multiple tasks.
Preferred Qualifications
Experience in biosimilar clinical trials.
Experience working in global clinical teams.
Familiarity with advanced data standards and programming workflows.
Key Competencies
Clinical data management and lifecycle execution
EDC system setup and eCRF design
Data review, query management, and reconciliation
Regulatory compliance (GCP, CDISC, 21 CFR Part 11)
Cross-functional collaboration and vendor management
Data quality assurance and database lock readiness
About the Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on the development and manufacturing of high-quality biosimilar medicines.
Within its Integrated Clinical and Medical Research (iCMR) function, the organization supports clinical strategies aligned with global regulatory requirements and biosimilar guidelines, enabling successful clinical trials and post-marketing activities worldwide.
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