Indero is hiring for the position of Clinical Data Manager in India for its CRO – Biometrics team. This is a home-based Clinical Data Manager job offering experienced clinical data management professionals an opportunity to manage clinical studies, electronic data capture (EDC) systems, data cleaning, database validation, vendor data reconciliation and database lock activities.
The Indero Clinical Data Manager job in India is particularly relevant for professionals with 3 to 5 years of clinical data management experience or candidates who have gained at least one year of experience as a Lead Clinical Data Manager within a CRO, pharmaceutical or biotechnology organization.
The selected Clinical Data Manager will act as a key data management liaison between project teams, sponsors and external vendors while ensuring clinical trial data is collected, managed and reported accurately, securely and in accordance with applicable regulations, ICH-GCP requirements, industry guidelines and company SOPs.
Indero is a contract research organization specializing in dermatology and rheumatology clinical research.
Key Responsibilities
As a Clinical Data Manager at Indero, the selected professional will be responsible for end-to-end clinical data management activities across assigned clinical studies.
Key responsibilities include:
- Lead and manage up to three clinical studies depending on study complexity, with support from the manager when required.
- Serve as the Clinical Data Management liaison for project teams, sponsors and external vendors.
- Participate in sponsor meetings and address clinical data management-related questions.
- Monitor study timelines, deliverables and scope of work to support timely and budget-conscious study execution.
- Develop electronic Case Report Form (eCRF) specifications, including data capture screens and edit-check specifications.
- Support programming and ongoing maintenance of clinical databases and EDC systems.
- Perform clinical database validation and User Acceptance Testing (UAT).
- Develop eCRF completion guidelines and training materials for site users and clinical monitors.
- Conduct training for site users and monitors on clinical database systems.
- Develop data transfer agreements and specifications for external vendor data, including laboratory data.
- Perform reconciliation between external data and information captured within the EDC system.
- Support AE/SAE reconciliation between clinical databases and sponsor safety databases when required.
- Support clinical data integrations involving systems such as ePRO and IWRS.
- Document and test data transfers between external clinical systems and the EDC platform.
- Develop and maintain the Data Management Plan (DMP) and other study-specific clinical data management documentation.
- Conduct ongoing clinical data review, query management and data cleaning throughout study conduct.
- Support database close and database lock activities.
- Perform medical coding within clinical databases when required.
- Generate clinical data listings and reports for review by project managers and other study team members.
- Monitor study metrics such as enrollment and CRF monitoring/approval status.
- Prepare and communicate clinical data status reports to project stakeholders.
- Ensure clinical data management documentation remains complete and current within the Trial Master File (TMF).
- Provide support to users experiencing issues with EDC systems.
- Support clinical database and documentation archiving.
- Contribute to the development and revision of Clinical Data Management Work Instructions.
- Mentor and train Clinical Data Coordinators on study-specific processes.
- Oversee outsourced Clinical Data Management activities and external service providers when applicable.
- Ensure vendor deliverables meet protocol, sponsor, timeline and applicable SOP requirements.
Education Requirements
Candidates interested in the Indero Clinical Data Manager India job should meet the following educational requirements:
Essential Qualification:
- B.Sc. or a bachelor’s degree in a related field of study.
Preferred Qualification:
- M.Sc. or a master’s degree in a related field is considered an asset.
Candidates should review their academic background against the requirements mentioned in the official application before applying.
Experience Required
Applicants should have:
- 3 to 5 years of Clinical Data Management experience, OR
- At least 1 year of Lead Clinical Data Manager experience in clinical research.
Relevant experience should preferably have been gained within:
- Contract Research Organizations (CROs)
- Pharmaceutical companies
- Biotechnology companies
- Clinical research organizations or related drug-development environments
This is therefore not positioned as a fresher Clinical Data Management vacancy in the supplied job description.
Skills Required for Clinical Data Manager
Indero is looking for candidates with strong technical and operational knowledge of clinical data management, including:
- Clinical Data Management
- Electronic Data Capture (EDC)
- eCRF design and specifications
- Edit Check Specifications
- Clinical Database Management
- Database Programming
- User Acceptance Testing (UAT)
- Data Cleaning and Data Review
- Query Management
- Database Lock
- External Data Reconciliation
- AE/SAE Reconciliation
- Data Transfer Agreements
- Data Management Plans (DMP)
- Trial Master File (TMF)
- CDISC standards
- CDASH
- SDTM
- MedDRA
- WHODrug
- Microsoft Excel
- SAS or similar tools
- Good Clinical Practice (GCP)
- ICH Guidelines
- FDA regulations and guidelines
- Clinical trial and drug development processes
Knowledge of SAS and database programming is considered an asset.
CDISC, EDC and Medical Coding Knowledge
Candidates should have a good understanding of CDISC SDTM and CDASH standards and extensive experience working with EDC systems and/or clinical database structures.
Knowledge of MedDRA and WHODrug dictionaries is also required, particularly because the role may involve medical coding and clinical/safety data reconciliation.
The Clinical Data Manager should additionally understand the drug development lifecycle, Good Clinical Practice requirements, ICH guidelines and applicable regulatory requirements.
Additional Skills
Successful candidates should demonstrate:
- Strong organizational skills
- Attention to detail
- Effective project planning
- Time management
- Excellent problem-solving abilities
- Strong written and verbal English communication
- Ability to manage competing priorities
- Ability to work in a fast-paced clinical research environment
- Effective sponsor and stakeholder communication
Knowledge of French is listed as an additional asset.
Work Location and Job Type
The position is available for candidates in India and is offered as a:
Home-Based Position
Indero specifically states that it will only accept applicants who are legally authorized to work in India.
This makes the opportunity particularly relevant to experienced Clinical Data Management professionals looking for remote Clinical Data Manager jobs in India.
Benefits of Working at Indero
According to the supplied job description, employees in this position may receive:
- Home-based working arrangement
- Flexible work schedule
- Ongoing learning and development opportunities
- Professional advancement opportunities
- Exposure to international clinical research projects
- Collaboration with experienced clinical research professionals
- Opportunity to work within a specialized dermatology and rheumatology CRO
About Indero
Indero is a Contract Research Organization (CRO) specializing in dermatology and rheumatology clinical research.
The organization traces its beginnings to 2000 and provides clinical research services while working with sponsors and research teams across international markets. Its stated organizational values include collaboration, innovation, reliability and responsiveness.
Who Should Apply?
This Clinical Data Manager opportunity may be suitable for professionals currently working as:
- Clinical Data Manager
- Lead Clinical Data Manager
- Senior Clinical Data Associate
- Clinical Data Management Specialist
- Clinical Database Specialist
- EDC Specialist
- Clinical Data Lead
Applicants should ensure that they satisfy the experience and education requirements before submitting an application.
How to Apply
