Senior Clinical Research Trainer

Job Title:

Experience Required:

Location:

Employment Type:

Salary Range:

Job Summary:

Senior Clinical Research Trainer

Key Responsibilities:

• Training Delivery & Development

• Design and deliver advanced-level training modules in

  Clinical Research,

  Pharmacovigilance

  ,

  Clinical Data Management

  , and

  GCP, ICH, USFDA, EMA

  guidelines.
• Conduct both

  theoretical

  and

  hands-on training

  sessions using real-world case studies, tools, and systems (e.g., Argus, ArisG, iMedidata, eTMF, Viva Vault, Oracle Clinical, MedDRA, CDISC).
• Develop assessments, workshops, and continuous learning tools to measure trainee progress.

• Curriculum & Content Creation

• Regularly update training material based on evolving

  industry standards

  ,

  regulatory changes

  , and

  best practices

  .
• Integrate

  mock projects

  and

  case-based scenarios

  to simulate real clinical research environments.

• Mentoring & Evaluation

• Mentor and support trainees pursuing careers in clinical research, PV, or CDM roles.
• Provide feedback and performance evaluations to ensure skill development and job readiness.

• Industry Collaboration

• Engage with clinical research organizations (CROs), hospitals, pharma companies, and academic partners for knowledge exchange, guest lectures, or internship support.

• Compliance & Quality

• Ensure all training adheres to

  GCP

  ,

  21 CFR Part 11

  ,

  ICH E6

  , and

  company/industry SOPs

  .

• Curriculum Development & Training Delivery

• Create modular, outcome-based training sessions for various roles within clinical trials (e.g., CRCs, CRAs, investigators).
• Customize content for in-person and virtual formats, incorporating PV and CDM where relevant.
• Develop quizzes, case studies, and role-play exercises to enhance applied learning.

• Pharmacovigilance & CDM Integration

• Explain pharmacovigilance systems (e.g. E2B, MedDRA coding) and signal detection workflows to trainees.
• Provide hands-on guidance in adverse event reporting, causality assessments, and regulatory submissions.
• Train learners on clinical data lifecycle—from CRF design and eCRF tools to data validation and database lock.

• Regulatory & Compliance Coaching

• Teach ICH-GCP, Schedule Y, NDCT rules 2019, ICMR, ICH E6 and global trial protocols with emphasis on ethics and patient safety.
• Conduct sessions on regulatory documentation (e.g., IBs, protocols, SOPs).
• Keep trainees up-to-date with evolving guidelines (e.g. EU CTR, FDA CFR, CDSCO policies).

• Facilitation & Engagement

• Lead interactive discussions, practical demonstrations, and Q&A sessions to clarify complex topics.
• Mentor new trainers and support onboarding of junior clinical research staff.
• Encourage critical thinking and professional development through ongoing support.

• Evaluation & Feedback

• Assess trainee comprehension using structured tools like pre/post assessments and scenario analysis.
• Provide individualized feedback to learners and suggest learning pathways for skill enhancement.
• Analyze training effectiveness and recommend improvements to management.

Qualifications

• Master's or PhD in Medical Sciences, Pharmacy, Life Sciences, or a related field.
• Minimum 10 years of professional experience in Clinical Research.
• Strong working knowledge of Pharmacovigilance and Clinical Data Management preferred.
• Proven track record of conducting successful training programs.
• Excellent communication and presentation skills.
• Ability to simplify complex concepts and engage learners at all levels.

Key Requirements:

• Education:

  Master’s degree or higher in Pharmacy, Life Sciences, Clinical Research, or related field.

• Experience:

  10+ years of professional experience in

  clinical research

  , with deep hands-on expertise in

  Pharmacovigilance

  and

  Clinical Data Management

  .

• Certifications Preferred:

  GCP Certification, PV/CDM Certification, or equivalent training credentials.
• Capable of handling interactive role-play and case-based scenarios.
• Attention to detail, adaptability, and team collaboration.

Technical Skills:

• Tools:

  Oracle Argus

  ,

  Oracle Clinical

  ,

  MedDRA

  ,

  WHO Drug

  ,

  EDC systems (e.g., Medidata, Inform)

• Documentation:

  ICF, SOPs, SAE Reports, Data Clarification Forms (DCF)

• Guidelines: In-depth knowledge of

  ICH-GCP

  ,

  FDA

  ,

  EMA

  , and

  Schedule Y, NDCT 2019

• Data Standards: Familiarity with

  CDISC

  ,

  SDTM

  ,

  ADaM

Soft Skills:

• Excellent verbal and written communication
• Strong organizational and mentoring abilities
• Analytical thinking and problem-solving skills
• Ability to simplify complex concepts for diverse learners

Preferred Qualities:

• Prior experience in

  corporate training

  ,

  academic instruction

  , or

  clinical research consultancy

• Ability to create engaging e-learning content or lead LMS-driven programs
• Published work or conference presentations in the clinical research field is a plus