Are you passionate about clinical research and biotech? Novotech, a leading global Contract Research Organization (CRO), is hiring for three critical roles in India: Senior Clinical Data Associate, Document Management Associate, and Clinical Document Specialist. If you have a background in clinical data management, trial master file (TMF) activities, or document management, this is your chance to join a dynamic team committed to advancing clinical trials and drug development.
About Novotech
Novotech is a full-service clinical CRO with a strong presence across 11 geographies, including Asia-Pacific, North America, and Europe. With over 3,700 clinical projects under its belt, Novotech specializes in Phase I to Phase IV clinical trials and bioequivalence studies. The company is ISO 27001 and ISO 9001 certified, ensuring the highest standards of IT security and quality management for its clients and patients.
Novotech is dedicated to fostering an inclusive workplace, offering flexible working options, paid parental leave, wellness programs, and ongoing development opportunities. The company is committed to gender equality and welcomes applicants from diverse backgrounds, including those who identify as LGBTIQ+, have disabilities, or have caring responsibilities.
Job Openings at Novotech
1. Senior Clinical Data Associate
Location: India
Experience: 4+ years in clinical coding or data management
Qualifications: Graduate in pharmacy or medical-related fields
Key Responsibilities:
- Lead clinical coding activities for multiple projects, ensuring compliance with SOPs and regulatory requirements.
- Review and resolve coding discrepancies, generate data queries, and maintain coding documentation.
- Act as the primary point of contact for external data matters and dictionary licensing.
- Provide training and mentorship to team members and contribute to process improvements.
Why Join?
This role offers the opportunity to work on cutting-edge clinical trials, lead coding activities, and develop best practices in a supportive and inclusive environment.
2. Document Management Associate (DMA)
Location: India
Experience: 12+ months in clinical research or TMF management
Qualifications: Background in pharmaceutical, CRO, or healthcare industry
Key Responsibilities:
- Manage Trial Master Files (TMF) in both electronic and paper formats, ensuring compliance with ICH GCP guidelines.
- Review and maintain study documents, ensuring they are inspection-ready at all times.
- Provide reports on document quality and support audits and regulatory inspections.
- Perform special projects related to TMF maintenance and organization.
Why Join?
This role is ideal for those looking to grow their career in clinical research while working with a globally recognized CRO.
3. Clinical Document Specialist (CDS)
Location: India
Experience: 5+ years in clinical research or TMF management
Qualifications: Bachelor’s degree in Life Sciences
Key Responsibilities:
- Oversee the setup and maintenance of Trial Master Files (TMF) for assigned projects.
- Act as a subject matter expert, ensuring compliance with regulatory requirements and Novotech SOPs.
- Train and mentor new team members and lead process improvement initiatives.
- Collaborate with internal and external stakeholders to resolve issues and ensure customer satisfaction.
Why Join?
This role offers the chance to lead TMF activities, drive process improvements, and contribute to the success of global clinical trials.
How to Apply
Application Link For Senior Clinical Data Associate
Application Link For Document Management Associate (DMA)
Application Link For Clinical Document Specialist (CDS)
