Executive - Economic Growth at KPMG Global Services

Gurgaon, haryana, India -

Full Time

Start Date

Immediate

Expiry Date

02 Sep, 26

Salary

0.0

Posted On

04 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Investigation Protocols, Clinical Performance Evaluation, Regulatory Compliance, Medical Device Documentation, Clinical Study Reports, Clinical Evaluation Reports, Risk Management, CTRI Submissions, SOP Development, Stakeholder Coordination

Industry

Business Consulting and Services

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.

Responsibilities

The role involves drafting and reviewing clinical investigation protocols and essential documentation for medical devices and in vitro diagnostics. It also requires coordinating with regulatory authorities and developing standardized templates and SOPs to ensure scientific rigor and compliance.