Senior Clinical Research Associate Position Available at Pfizer
A rare chance has emerged for experienced professionals in clinical research as Pfizer seeks to fill the role of Senior Clinical Research Associate I in Mumbai, India. This full-time position calls for individuals with a strong background in site management and monitoring of clinical trials, ensuring patient safety and adherence to regulatory standards. The role is pivotal for those looking to make a significant impact in the field of clinical research, particularly within a leading global pharmaceutical company.
About Pfizer:
Pfizer is a global pharmaceutical company committed to discovering, developing, and delivering innovative medicines and vaccines. With a presence in numerous countries, Pfizer operates in various therapeutic areas, including oncology, vaccines, and infectious diseases. The company is known for its dedication to improving health outcomes and enhancing patient care through scientific advancements and rigorous clinical research. Pfizer’s commitment to excellence and innovation has established it as a leader in the pharmaceutical industry, continuously striving to meet the evolving needs of patients worldwide.
Job Details:
- Location: India – Mumbai
- Time Type: Full-time
- Job Requisition ID: 4964184
Job Description:
The Senior Clinical Research Associate I is responsible for the site management, site monitoring, and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices, and Pfizer standards. The role is accountable for managing investigator site relationships to ensure effective delivery of clinical trials, safeguarding quality, and enhancing the company’s image with external stakeholders. This position plays a crucial role in the successful execution of clinical trials, contributing to the advancement of medical knowledge and the development of new treatments.
Key Responsibilities:
- Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable laws.
- Manage operational aspects for implementation of clinical trial activities from site initiation through to database lock.
- Serve as the primary point of contact for assigned investigator sites and facilitate information flow between the study team and sites.
- Conduct onsite, remote/electronic monitoring for study site initiation, routine monitoring, and closure activities.
- Monitor site level AEs and SAEs, collaborating with the Drug Safety Unit as necessary.
- Submit all required reports and documentation within required timeframes.
- Identify and resolve investigator site issues, developing corrective actions with site personnel.
- Support database release as needed and may undertake the responsibilities of an unblinded monitor.
Eligibility Criteria for this Senior Clinical Research Associate position:
- Bachelor’s degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, or a medical background.
- Minimum 3 years of relevant experience in Clinical Research site monitoring, preferably 2 years in Oncology.
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local regulations.
- Must be fluent in English and the native language(s) of the country they will work in.
Required Skills:
- Advanced knowledge of clinical research and development processes.
- Demonstrated ability to support sponsor regulatory interactions/inspections.
- Effective verbal and written communication skills.
- Proven ability to work in a matrix team environment.
Travel Requirements for this Senior Clinical Research Associate position:
- Significant travel (60-80%) within the area is required.
- May require some international travel and weekend travel.
- Valid driver’s license and passport required.
