Location: Remote | Department: Data Management | Reports To: VP/Head of Biometrics

Employment Type: Full-Time | Experience Required: 5+ years in clinical data management (CRO or Sponsor environment)

About ClinFocus

ClinFocus is a data-first contract research organization (CRO) and clinical intelligence company that leverages AI to automate clinical data workflows across the trial lifecycle. Operating in regulated environments, ClinFocus delivers end-to-end biometrics services, including clinical data management, statistical programming, medical coding, and clinical systems development, with a commitment to quality, speed, and regulatory compliance.

Our team supports complex clinical trials across oncology, rare diseases, neurology, and other therapeutic areas. We partner with biotech and pharmaceutical companies to deliver high-quality clinical data that accelerates drug development while maintaining the highest standards of regulatory compliance.

Role Overview

The Clinical Data Manager (CDM) is responsible for the end-to-end management of clinical trial data, ensuring data quality, integrity, and regulatory compliance throughout the study lifecycle. This role oversees database development, data review, discrepancy management, vendor oversight, reconciliation activities, and database lock while collaborating with cross-functional teams to ensure timely and accurate clinical data deliverables.

The ideal candidate has strong expertise in clinical data management processes, Electronic Data Capture (EDC) systems, CDISC standards, and global regulatory requirements, with proven experience working in a CRO or pharmaceutical environment.

Key Responsibilities1. Clinical Data Management

- Manage clinical data activities from study start-up through database lock and study close-out.
- Develop and review Data Management Plans (DMPs), Data Validation Plans (DVPs), CRF Completion Guidelines, and study documentation.
- Design, review, and validate Case Report Forms (CRFs) and electronic CRFs (eCRFs).
- Coordinate database build, User Acceptance Testing (UAT), and production release.
- Develop and review edit checks, derivations, and data validation specifications.
- Ensure timely collection, cleaning, and verification of clinical trial data.
- Monitor data quality metrics and resolve data issues proactively.

2. Data Cleaning and Quality Management

- Perform ongoing clinical data review and ensure data completeness, consistency, and accuracy.
- Manage data queries and collaborate with investigative sites for timely resolution.
- Conduct manual and automated data reviews.




- Review protocol deviations and identify potential data trends.
- Ensure compliance with ALCOA+ principles and Good Clinical Data Management Practices (GCDMP).

3. Database and EDC Management

- Configure and maintain Electronic Data Capture (EDC) systems.
- Support study database design and validation activities.
- Coordinate database migrations, amendments, and mid-study updates.
- Perform User Acceptance Testing (UAT) and document testing results.
- Ensure databases comply with CDISC standards where applicable.

4. Vendor and External Data Management

- Manage third-party vendor data transfers including:
- Central laboratories
- ECG vendors
- Imaging vendors
- ePRO/eCOA providers
- Randomization systems
- Review external data transfer specifications.
- Perform reconciliation between external vendor data and EDC data.
- Coordinate issue resolution with vendors.

5. Medical Coding and Reconciliation

- Oversee medical coding activities using MedDRA and WHODrug dictionaries.
- Review coding outputs for quality and consistency.
- Perform reconciliation of:
- Serious Adverse Events (SAEs)
- Safety databases
- Laboratory data
- Medical coding
- Randomization data
- Support ongoing safety review activities.

6. Regulatory Compliance

- Ensure compliance with:
- ICH-GCP
- FDA 21 CFR Part 11
- GCDMP
- CDISC Standards
- HIPAA
- GDPR
- Maintain complete audit trails and study documentation.
- Participate in sponsor audits and regulatory inspections.
- Ensure inspection readiness throughout the study lifecycle.

7. Cross-Functional Collaboration

- Work closely with:
- Clinical Operations
- Biostatistics
- Statistical Programming
- Medical Monitoring
- Pharmacovigilance
- Clinical Systems
- Regulatory Affairs
- Participate in study meetings and provide data management updates.
- Support study timelines and milestone planning.

8. Database Lock and Study Close-Out

- Coordinate database freeze and database lock activities.
- Ensure all discrepancies are resolved prior to lock.
- Complete reconciliation activities.
- Prepare database lock documentation.
- Support final study deliverables and submission readiness.

QualificationsEducation

- Bachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, Health Informatics, Computer Science, Biostatistics,



Data Science, or a related healthcare discipline.
- Master's degree is an advantage but not required.

Experience

- Minimum of 5 years of clinical data management experience within a CRO, pharmaceutical, or biotechnology environment.
- Experience managing Phase I–IV clinical trials.
- Experience working with global, multi-center clinical studies.
- Experience leading database build, UAT, and database lock activities.

Preferred Certifications

- CCDM (Certified Clinical Data Manager – SCDM)
- ACRP Certified Professional (ACRP-CP)
- SOCRA Certified Clinical Research Professional (CCRP)
- SAS Clinical Programming Certification (preferred)
- CDISC Certification (preferred)

Skills and Competencies

- Strong understanding of clinical trial processes and ICH-GCP guidelines.
- Expert knowledge of Electronic Data Capture (EDC) systems such as Medidata Rave, Veeva Vault CDMS, Oracle InForm, REDCap, or OpenClinica.
- Experience with CDISC standards (SDTM, CDASH).
- Knowledge of MedDRA and WHODrug coding dictionaries.
- Experience with data reconciliation and medical coding oversight.
- Familiarity with clinical databases, SQL, Excel, and data visualization tools.
- Excellent understanding of FDA 21 CFR Part 11, HIPAA, GDPR, and global regulatory requirements.
- Strong project management and organizational skills.
- Excellent analytical and problem-solving abilities.
- Exceptional attention to detail and commitment to data quality.
- Strong verbal and written communication skills.
- Ability to manage multiple studies and competing priorities in a fast-paced setting.
- Experience working effectively in remote and global cross-functional teams.

Why Join ClinFocus?

- Work with a rapidly growing AI-enabled Clinical Research Organization.
- Contribute to cutting-edge oncology, neurology, and rare disease studies.
- Collaborate with global pharmaceutical and biotechnology sponsors.
- Opportunity to work with industry-leading clinical technologies and data platforms.
- Flexible remote work environment.
- Career growth within an innovative and technology-driven organization.

ClinFocus is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

To apply, submit your resume and cover letter to: [email protected]

Job Type: Full-Time

Work Location: Remote

Pay: ₹286,226.49 - ₹1,218,918.90 per year

Work Location: In person

📌 Clinical Data Manager (India)
🏢 Clinfocus
📍 India