Senior Clinical Data Manager

Zoho; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Zoho is seeking a Senior Clinical Data Manager to own data management across the full clinical trial lifecycle, from study start-up through close-out. This fully remote role is open to USA/Canada-based candidates, requiring hands-on CDM experience and strong regulatory awareness.

The role includes designing the DMP, CRF specs, eCRF/EDC testing, data validation, and ongoing data quality checks, while coordinating with CROs, programming, statistics, and safety to keep studies on schedule and

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Pharmacy, Nursing, Computer Science, or a related field.
• 8+ years of hands-on clinical data management experience in pharma/biotech/CRO.
• Strong working knowledge of at least one major EDC system (Medidata Rave, Oracle InForm/Clinical One, Veeva CDMS).
• Familiarity with CDISC standards (CDASH, SDTM) and MedDRA/WHO Drug dictionaries.

Responsibilities

• Develop the Data Management Plan (DMP) and CRF completion guidelines.
• Design, build, and test eCRFs and EDC databases with validation and UAT.
• Lead data cleaning, queries, and reconciliation across sites.
• Oversee CRO/vendor data management activities and ensure inspection readiness.

Skills

Clinical data management

EDC systems

Remote work

Regulatory awareness

Education

Bachelor’s degree in Life Sciences/related field

Tools

Medidata Rave

Oracle InForm/Clinical One

Veeva CDMS

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• Remote Job

Job Description

This is a remote position.

About the Role

We are looking for a Senior Clinical Data Manager to own data management across the full clinical trial lifecycle: study start-up, study conduct, and study close-out. You bring deep, hands‑on CDM experience, ramp up quickly, and work independently with minimal oversight while keeping data quality, timelines, and regulatory compliance on track. This is a fully remote position open to candidates based in USA/ Canada.

Key Responsibilities

Study Start-up

• Develop the Data Management Plan (DMP), CRF completion guidelines, data validation specifications, and other study documents.
  
• Design, build, and test eCRFs and EDC databases, including edit checks and UAT.
  
• Define data transfer specifications and agreements for external data sources (labs, ePRO/eCOA, IRT, PK).
  
• Set up coding conventions (MedDRA, WHO Drug) and the data review plan.
  
• Align with Biostatistics, Clinical Operations, Programming, and Safety on database requirements and timelines.
  
• Support CRO and vendor kickoff and set up oversight processes.
  

Study Conduct

• Perform ongoing data cleaning and review, and generate, issue, and resolve queries with sites and cross‑functional teams.
  
• Reconcile external data and serious adverse event (SAE) data against the clinical database.
  
• Code adverse events, medications, and medical history using MedDRA and WHO Drug.
  
• Manage database change requests and amendments, including mid‑study updates.
  
• Run data quality checks and metrics reporting, and flag risks and issues early.
  
• Oversee CRO and vendor data management activities and deliverables.
  
• Maintain inspection‑ready study documentation in the TMF.
  

Study Close‑out

• Lead database lock activities, including final data review, query closure, reconciliation, and coding sign‑off.
  
• Plan and execute interim locks, database freeze, and final lock, including unlock/relock when required.
  
• Deliver final datasets to Biostatistics and Programming, and support SDTM and CDISC deliverables.
  
• Archive the database and study documentation, and complete TMF filing.
  
• Support audits, inspections, and post‑lock queries.
  
• Lead lessons‑learned and close‑out reviews.
  

Across All Phases

• Ensure compliance with ICH‑GCP, Health Canada, FDA, and EMA requirements, company SOPs, and CDISC standards.
  
• Mentor junior data managers and contribute to process improvements.
  

Requirements

Required Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Pharmacy, Nursing, Computer Science, or a related field.
  
• 8+ years of hands‑on clinical data management experience in pharma, biotech, or a CRO, with experience across study start‑up, conduct, and close‑out.
  
• Strong working knowledge of at least one major EDC system (e.g., Medidata Rave, Oracle InForm/Clinical One, Veeva CDMS, or similar).
  
• Solid understanding of the clinical trial lifecycle, ICH‑GCP, and data management best practices.
  
• Proven experience with DMPs, edit checks, data validation, query management, and database lock.
  
• Familiarity with CDISC standards (CDASH, SDTM) and medical dictionaries (MedDRA, WHO Drug).
  
• Excellent attention to detail, with strong written and verbal communication skills.
  
• Ability to work independently, prioritize multiple studies, and meet tight deadlines in a remote setting.
  

Preferred Qualifications

• Experience across multiple therapeutic areas (e.g., oncology, rare disease, CNS).
  
• Experience with SAS, SQL, R, Python, or data visualization tools such as JReview or Spotfire.
  
• Exposure to risk‑based quality management (RBQM) and central monitoring.
  
• Experience managing CRO or vendor relationships.
  

Core Competencies

Ownership and accountability, problem‑solving, quick learner, cross‑functional collaboration, and quality‑first mindset.