Are you passionate about clinical research and biotechnology? Novotech, a leading global Contract Research Organization (CRO), is hiring for two exciting roles in India: Inhouse Clinical Research Associate (IHCRA) and Clinical Data Programmer I (SDTM). If you’re looking to advance your career in the clinical research industry, this is your chance to join a diverse and supportive global organization. Read on to learn more about these roles, the company, and how to apply.
Job 1: Inhouse Clinical Research Associate (IHCRA)
Job Description
The Inhouse Clinical Research Associate (IHCRA) will provide in-house support to the clinical team, ensuring compliance with ICH GCP guidelines, regulatory requirements, and Novotech or client SOPs. This role is ideal for individuals with a background in life sciences or administration and a passion for clinical research.
Key Responsibilities
- Support the clinical team’s in-house activities on assigned projects.
- Coordinate and maintain clinical study documentation in the Trial Master Files (TMF).
- Assist in essential document development, collection, and management.
- Manage the Clinical Trial Management System (CTMS) and ensure site compliance.
- Create Investigator Site Files and coordinate trial materials.
- Assist with IRB submissions, safety reporting, and project close-out activities.
Qualifications
- Relevant experience/qualifications in Life Sciences or related fields.
- Entry to less than 2 years of experience as an Inhouse CRA or in relevant roles.
- Experience in the pharmaceutical, CRO, or healthcare industry is advantageous.
Job 2: Clinical Data Programmer I (SDTM)
Job Description
The Clinical Data Programmer I (SDTM) will be responsible for SDTM programming based on clinical protocols, eCRF, and Statistical Analysis Plans. This role involves collaborating with biostatisticians and stakeholders to produce high-quality SDTM outputs.
Key Responsibilities
- Perform SDTM programming and annotation of SDTM CRF.
- Conduct SDTM Quality Control, Double Programming, and Peer Review.
- Develop Define.xml datasets and regulatory documents for submission.
- Adhere to company programming standards and ensure proper documentation.
- Maintain study documentation, programs, and files.
Qualifications
- Bachelor’s Degree in Life Sciences, Computer Science, Mathematics, Statistics, or related fields.
- Knowledge of SAS, SDTM Programming, Clinical Protocols, and Statistical Analysis Plans.
- Experience in the pharmaceutical industry or CRO is preferred.
About Novotech
Novotech is a global full-service CRO headquartered in Sydney, Australia, with 34 offices across Asia-Pacific, North America, and Europe. With over 3,000 employees and 5,000 site partnerships, Novotech provides comprehensive clinical development services across all trial phases and therapeutic areas.
Novotech is committed to maintaining the highest IT security and quality standards, holding ISO 27001 and ISO 9001 certifications. The company fosters a collaborative and inclusive work environment, offering flexible working options, paid parental leave, wellness programs, and ongoing development opportunities.
Why Join Novotech?
- Work with a diverse and supportive global team.
- Collaborate on cutting-edge clinical research projects.
- Enjoy flexible work arrangements and comprehensive benefits.
- Be part of a company that values partnership, collaboration, and innovation.
Application Link For Inhouse Clinical Research Associate (IHCRA)
