Are you passionate about clinical research and looking for a rewarding career in India’s thriving CRO industry? Indero, a leading contract research organization specializing in dermatology and rheumatology, is hiring for two exciting roles: Clinical Data Coder and Regulatory Documents Assistant in India. These permanent, full-time positions offer a dynamic work environment, flexible schedules, and opportunities for professional growth. Join a team driven by collaboration, innovation, and reliability at Indero, a CRO with a stellar reputation since 2000.
Clinical Data Coder Responsibilities
As a Clinical Data Coder, you will play a critical role in ensuring the accuracy and integrity of clinical trial data. Key responsibilities include:
- Coding Medical Data: Accurately code medical terms and medications using industry standards like MedDRA and WHO Drug.
- Dictionary Management: Assign and coordinate medical dictionaries to meet study requirements and perform dictionary up-versioning activities.
- Guideline Development: Develop and maintain coding guidelines to ensure consistency and compliance.
- Data Review and Validation: Conduct thorough data reviews, validate coding setups, and test programming for coding reports and databases.
- Query Management: Write and resolve data clarifications to maintain data quality.
- Collaboration: Work closely with the Data Management team to meet project timelines and objectives.
- Compliance: Adhere to regulatory requirements, industry guidelines, and Indero’s SOPs.
Regulatory Documents Assistant Responsibilities
The Regulatory Documents Assistant ensures the Trial Master File (TMF) and Investigator’s Study File (ISF) are maintained with precision. Key duties include:
- TMF Management: Develop and maintain the TMF structure, file/import documents, and assign metadata.
- Quality Control: Perform record reviews for accuracy and compliance with ICH-GCP standards.
- eTMF Oversight: Set up and conduct quality reviews for the electronic TMF, addressing findings promptly.
- Collaboration: Work with project teams to define document expectations and resolve TMF issues.
- Regulatory Compliance: Review site documents for adherence to SOPs and regulations.
- Administrative Support: Assist with tracking tools, study material preparation, and clinical site shipments.
Qualifications
Clinical Data Coder
- Education: Bachelor’s degree in pharmacy, life sciences, or related field, or medical/nursing qualification.
- Experience: 2 years of relevant experience in clinical trials or pharmaceuticals (preferred).
- Skills: Thorough knowledge of medical terminology and dictionaries (MedDRA, WHODD); strong query management and organizational skills; excellent English communication.
- Regulatory Knowledge: Familiarity with Good Clinical Practices (GCP) and Health Canada/FDA regulations.
- Attributes: Analytical mindset, attention to detail, ability to manage multiple projects.
Regulatory Documents Assistant
- Education: College degree.
- Experience: Experience in clinical research within biotechnology, pharmaceutical, or CRO industries.
- Skills: Proficiency in Microsoft Word and Excel; strong organizational and multitasking abilities; intermediate English (French is an asset).
- Attributes: Detail-oriented, ability to prioritize tasks, and commitment to meeting deadlines.
Why Join Indero?
- Flexible Work Schedule: Balance work and personal life with adaptable hours.
- Permanent Role: Secure a full-time position with long-term career prospects.
- Benefits Package: Enjoy comprehensive company benefits tailored to your needs.
- Learning and Development: Access ongoing training to enhance your skills.
- Collaborative Environment: Work with brilliant colleagues in a culture of innovation and responsiveness.
About Indero
Founded in 2000, Indero is a Montreal-based CRO renowned for its expertise in dermatology and rheumatology clinical research. With a growing presence in North America and Europe, Indero delivers high-quality services that exceed client expectations. Join a team that values collaboration, innovation, and reliability.
How to Apply
Application Link for Regulatory Documents Assistant (India)
Application Link for Clinical Data Coder (India)
