Red Nucleus, a globally recognized life sciences solutions provider, is hiring an Associate/Senior Associate – Clinical Data Management to join its Clinical Research & ITC team. This opportunity is ideal for professionals with experience in clinical data management, electronic data capture (EDC), and clinical research operations who want to work in a remote global environment.
The role involves managing clinical and patient-reported data within electronic data capture platforms, ensuring data integrity, compliance with regulatory requirements, and high-quality clinical study data. Candidates with experience in clinical trials, GCP, data standards, and regulatory compliance are encouraged to apply.
This is a mid-level clinical research job in India offering the opportunity to work with a global CRO-like environment and collaborate with biotech clients, clinical operations teams, and technology developers.
Job Overview
| Parameter | Details |
|---|---|
| Position | Associate / Senior Associate – Clinical Data Management |
| Company | Red Nucleus |
| Location | Pune, India (Remote) |
| Department | Clinical Research & ITC |
| Job Type | Full-Time |
| Experience | Mid-level |
| Industry | Clinical Research / Life Sciences |
Key Responsibilities
The Clinical Data Management Associate will be responsible for ensuring accurate collection, validation, and management of clinical study data.
Major responsibilities include:
- Manage clinical and patient-reported data within Electronic Data Capture (EDC) platforms including iTakeControl
- Monitor databases and video evidence to ensure data quality and database integrity
- Support clinical research projects from study setup to closeout
- Maintain communication with internal teams, sponsors, and research sites
- Perform data review, query generation, reconciliation, and validation
- Manage data transfer, migration, extraction, and reporting activities
- Develop Data Management Plans (DMP), CRF specifications, and EDC documentation
- Assist in site initiation visits (SIV) and training for research sites
- Support UAT testing, product launches, and clinical operations activities
- Ensure compliance with SOPs, regulatory guidelines, and GxP standards
Required Qualifications
Candidates applying for the Red Nucleus Clinical Data Management job should meet the following requirements:
Education
- Undergraduate degree from an accredited university
- Preferred backgrounds include:
- Life Sciences
- Clinical Research
- Pharmacy
- Biotechnology
- Biomedical Sciences
Experience
- Experience in clinical data management or clinical research
- Experience with clinical study protocols, registries, or observational research
- Familiarity with EDC, ePRO, or EHR systems
- Knowledge of data migration, reporting, and data transfers
Regulatory Knowledge
Candidates should be familiar with:
- ICH-GCP guidelines
- FDA 21 CFR Part 11
- HIPAA and GDPR compliance
- Clinical trial phases Phase I – Phase III
- Clinical data standards such as CDISC, CDASH, SDTM
- Medical dictionaries such as MedDRA and WHO Drug
Required Skills
Successful candidates should demonstrate:
- Strong clinical data management expertise
- Proficiency in Microsoft Office (Excel, Word, PowerPoint)
- Knowledge of clinical research systems and data platforms
- Excellent communication and stakeholder management skills
- Ability to manage multiple clinical research projects simultaneously
- High attention to detail and data quality management
- Comfort working with new digital technologies and mobile applications
Preferred Qualifications
- 7–10 years professional experience in clinical research
- Experience with digital health or mobile applications
- Exposure to rare disease studies or gene therapy trials
- Experience working with central labs or specialty vendors
Benefits of Working at Red Nucleus
Red Nucleus provides a collaborative work culture with strong employee benefits:
- Competitive salary and incentive programs
- Comprehensive health and wellness benefits
- Flexible remote work arrangements
- Generous paid time off
- Professional development opportunities
- Inclusive and diverse workplace culture
- Global team collaboration and networking
The organization is also recognized internationally as a Great Place to Work and focuses on innovation in medical communications, scientific advisory, and clinical research solutions.
How to Apply
