Clinical Data Management (CDM) & Regulatory Affairs

? Location: Remote

? Employment Type: Full time

About the Role:

Biotecnika is looking for an experienced Clinical Data Management & Regulatory Affairs Trainer to develop and deliver industry-focused training programs for students and professionals. The role involves curriculum development, live online training, mentoring, and creating engaging learning content.

Key Responsibilities:

- Develop course content, PPTs, assessments, quizzes, and assignments.
- Deliver interactive online training sessions.
- Mentor students through projects and career guidance.
- Create learning resources, YouTube content, and webinar materials.
- Conduct hands-on training using case studies and industry-relevant tools.
- Stay updated with CDM tools and global regulatory guidelines (FDA, EMA, CDSCO, ICH, WHO).





Eligibility:

- Master's Degree or Ph.D. in Life Sciences, Pharmacy, Clinical Data Management, or Regulatory Affairs.
- Minimum 2 years of core industry experience in Clinical Data Management and Regulatory Affairs.
- Experience with CDM tools and regulatory documentation.
- Prior teaching/training experience is preferred.
- Excellent communication and presentation skills.

Preferred Skills:

- Knowledge of Medidata Rave, OpenClinica, Veeva Vault, and AI tools.
- Understanding of ISO standards, ICH guidelines, audits, and regulatory submissions.
- Certifications such as RAPS, DIA, or IBRAS are an added advantage.

📌 Clinical Data Management & Regulatory Affairs (Bengaluru)
🏢 BioTecNika
📍 Bengaluru