Clinical Document Specialist – Join Our Growing Team in Bangalore!
Summary:
Novotech, a leading global Contract Research Organization (CRO), is seeking a highly motivated and experienced Clinical Document Specialist (CDS) to join our dynamic team in Bangalore. In this pivotal role, you will be responsible for managing both electronic and paper Trial Master Files (TMFs), ensuring compliance with ICH-GCP guidelines, and collaborating closely with internal teams and clients to support innovative clinical research programs. If you have a strong background in TMF management and are looking for an opportunity to advance your career in a supportive and collaborative environment, we encourage you to apply!
About Novotech:
Novotech is a dynamic and growing CRO with a global footprint, dedicated to accelerating clinical development for biopharmaceutical companies of all sizes. We offer a full range of clinical services, from Phase I to Phase IV, with a strong focus on oncology, infectious diseases, and other specialty therapeutic areas. At Novotech, we are committed to fostering an inclusive and supportive work environment where our employees can thrive and make a meaningful impact on global health.
Job Description:
As a Clinical Document Specialist, you will play a crucial role in ensuring the integrity and compliance of our clinical trial documentation. You will be responsible for managing the TMF, both electronic (eTMF) and paper-based, and ensuring that all documents are properly filed, maintained, and readily accessible. You will also collaborate with various stakeholders, including project managers, clinical operations teams, and clients, to ensure that TMF processes are efficient and effective.
Key Responsibilities:
- Perform document uploading and quality control (QC) review according to Novotech Standard Operating Procedures (SOPs).
- Liaise with clients and alliance partners regarding assigned TMF responsibilities.
- Mentor and train new team members on TMF workflows and best practices.
- Lead TMF process improvement initiatives and workflow optimizations.
- Support the development of filing plans in collaboration with Team Leads and Project Managers.
- Ensure TMF compliance with regulatory updates and Good Clinical Practice (GCP) guidelines.
- Assist in managing the Document Management Assistant (DMA) team when required.
- Evaluate customer satisfaction related to TMF processes and address any issues or concerns.
- Participate in clinical operations meetings and contribute to SOP improvements.
- Support archived study maintenance and paper file organization.
- Ensure high-quality documentation management practices aligned with Novotech standards.
Eligibility & Qualifications:
- Bachelor’s Degree in Life Sciences (minimum requirement).
- 5+ years of experience in clinical research or related functions.
- Hands-on expertise in TMF/eTMF management.
- Experience in pharmaceutical, CRO, or healthcare industries preferred.
- Strong understanding of eTMF systems, GCP, and clinical operations.
- Excellent communication, documentation, and organizational skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and as part of a team.
- Strong attention to detail and commitment to quality.
Why Join Novotech? (Benefits & Culture)
Novotech is dedicated to creating a positive and rewarding work environment for our employees. We offer a comprehensive benefits package and a culture that values collaboration, innovation, and work-life balance.
- Flexible working options.
- Paid parental leave for all genders.
- Wellness programs & training opportunities.
- Inclusive environment supporting LGBTIQ+, caregivers, and people with disabilities.
- Structured career development opportunities.
- Collaborative, global clinical operations culture.
- Commitment to gender equality and fair hiring practices.
Job Location:
Ground Floor, Unit 1, Block E, Helios Business Park, Bangalore – 560103, India
Salary Range (Estimated):
INR 6,50,000 – 12,00,000 per annum
(Industry-standard estimate for Clinical Document Specialist roles in India.)
How to Apply:
If you are a qualified and motivated clinical research professional looking to advance your career in TMF management, we encourage you to apply! Please submit your resume and cover letter through the application link. We look forward to hearing from you!