Indero, formerly Innovaderm, is hiring for the position of Clinical Data Coordinator in India. This is a permanent, entry-level opportunity focused on clinical data management activities supporting clinical trials.
The role involves data review, data reconciliation, discrepancy management, study metrics, study reporting, user maintenance, user acceptance testing, database design support, and clinical data management documentation.
Job Details
| Details | Information |
|---|---|
| Company | Indero – Formerly Innovaderm |
| Position | Clinical Data Coordinator |
| Job Type | Permanent, Full-time |
| Experience | Entry-level; 1 year of clinical data management experience is an asset |
| Location | India |
| Industry | Contract Research Organization (CRO) |
| Therapeutic Areas | Dermatology and Rheumatology |
Position
Clinical Data Coordinator
The Clinical Data Coordinator will support clinical data management activities to ensure clinical trial data is collected, managed, and reported clearly, accurately, and securely. The position will work in accordance with applicable regulatory requirements, industry guidelines, Indero SOPs, sponsor requirements, and project timelines.
Responsibilities
- Provide general data management support to project teams, sponsors, and external vendors.
- Support the Lead Data Manager with data review.
- Perform data reconciliation activities.
- Support discrepancy management.
- Maintain study metrics and monitor study status, including enrollment and CRFs monitored or approved.
- Provide data status reports to the project team as required.
- Generate ad-hoc study reports.
- Support user maintenance activities.
- Assist with User Acceptance Testing (UAT).
- Assist with database design.
- Assist with creating Data Management Plans (DMPs) and other clinical data management documentation.
- Assist in ensuring clinical data management documentation is complete and up to date in the Trial Master File (TMF).
Eligibility & Qualifications
- Education: B.Sc. or related field.
- Experience: 1 year of clinical data management experience in the pharmaceutical industry or CRO environment is considered an asset.
- Experience using an EDC system such as Medidata Rave or Medrio is considered an important asset.
- General knowledge of CDASH/SDTM is considered an asset.
- Understanding of the drug development process and applicable regulations, including Good Clinical Practices (GCP), ICH Guidelines, and applicable Health Canada and FDA regulations/guidelines.
Required Skills
Candidates should have:
- Strong analytical capabilities and an ability to work with data.
- Proficiency with computer technology and the ability to learn new applications.
- Strong organization, attention to detail, project planning, and time management skills.
- Strong verbal and written communication skills in English.
- Ability to work in a fast-paced environment.
- Ability to prioritize multiple competing demands.
- Excellent interpersonal and problem-solving skills.
- Ability to work independently and as part of a team.
- Interest in working with systems and technology and continuously learning.
Knowledge of French is an additional asset.
Work Environment & Benefits
Indero describes its work environment as collaborative, innovative, reliable, and responsive.
The position includes:
- Flexible work schedule
- Permanent full-time position
- Company benefits package
- Ongoing learning and development
- Advancement opportunities
About Indero
Indero, formerly Innovaderm, is a contract research organization specializing in dermatology and rheumatology. Founded in 2000, the organization provides clinical research and related services and is based in Montreal, with operations across North America and Europe.
Its capabilities include clinical monitoring, project management, quality assurance, medical writing, medical monitoring, clinical development and regulatory consulting, pharmacovigilance, and biostatistics and data management.
Application Details
