Executive - Clinical Research and Regulatory Affairs
Kpmg India Services Llp
Work from Office
Full Time
Min. 1 yearJob Description
Executive - Economic Growth
Description
About KPMG in India
KPMG entities in India are professional services firm(s). These Indian member firms are affiliated with KPMG International Limited. KPMG was established in India in August 1993. Our professionals leverage the global network of firms, and are conversant with local laws, regulations, markets and competition. KPMG has offices across India in Ahmedabad, Bengaluru, Chandigarh, Chennai, Gurugram, Jaipur, Hyderabad, Jaipur, Kochi, Kolkata, Mumbai, Noida, Pune, Vadodara and Vijayawada.
KPMG entities in India offer services to national and international clients in India across sectors. We strive to provide rapid, performance-based, industry-focused and technology-enabled services, which reflect a shared knowledge of global and local industries and our experience of the Indian business environment.
To Assist the Authority in:a. To draft, critically review, and finalize clinical investigation protocols for medical devices and clinical performance evaluation protocols for in vitro diagnostics, in accordance with applicable regulatory, ethical, and scientific standards.
b. To prepare, review, and standardize essential clinical documentation, including Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), and Case Report Forms (CRFs), ensuring completeness and regulatory compliance.
c. To develop comprehensive Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), risk management files, and executive summaries to support regulatory submissions and post-evaluation documentation requirements.
d. To draft and review submissions to the Clinical Trials Registry–India (CTRI) for registration of clinical investigations and performance evaluation studies, ensuring accuracy and regulatory alignment.
e. To coordinate and liaise with Data Safety Monitoring Boards (DSMBs), regulatory authorities, and clinical investigators to secure timely approvals and ensure adherence to applicable regulatory and safety requirements.
f. To collaborate closely with clinical investigators, biostatisticians, regulatory experts, and research and development teams to ensure scientific rigor, compliance with applicable standards, and regulatory alignment throughout the conduct of clinical studies.
g. To design, develop, and implement standardized templates, Standard Operating Procedures (SOPs), and guidance documents to strengthen protocol development processes and ensure sustained regulatory compliance.
Equal employment opportunity information KPMG India has a policy of providing equal opportunity for all applicants and employees regardless of their color, caste, religion, age, sex/gender, national origin, citizenship, sexual orientation, gender identity or expression, disability or other legally protected status. KPMG India values diversity and we request you to submit the details below to support us in our endeavor for diversity. Providing the below information is voluntary and refusal to submit such information will not be prejudicial to you. |
Qualifications
Master’s in Life Sciences, Pharmaceutical Sciences, Biotechnology, Microbiology, Biochemistry or Bachelor of Medicine or surgery(MBBS), BDS, Biomedical, Biochemical or Mechanical Engineering and related fields
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