AIn the ever-evolving field of clinical research, Biorasi stands out as an award-winning, innovative, and customer-focused organization. As we expand our global presence, we invite passionate individuals to join our dynamic team in Mumbai as we drive new therapies to patients worldwide. If you are enthusiastic about clinical research and looking for a fulfilling career, here is your opportunity.
About Biorasi
Biorasi is a full-service clinical research organization (CRO) known for its commitment to operational excellence and customer satisfaction. We pride ourselves on fostering a collaborative and supportive work environment where every team member’s strengths are harnessed. Our mission is to ensure that groundbreaking therapies reach patients in need, and we are growing our team to meet this goal.
Open Positions
1. Site Network Specialist (Global Feasibility)
As a Site Network Specialist, you will play a crucial role in facilitating clinical trials by establishing and maintaining contacts with prospective sites, Site Management Organizations (SMOs), and Principal Investigators (PIs) within your assigned regions. Your responsibilities will include:
- Assisting in feasibility and site networking activities while evaluating challenges related to regulatory, ethical, and operational aspects in clinical studies.
- Creating strategic feasibility plans by identifying prospective sites, performing benchmarking, and conducting competition analysis.
- Maintaining accurate logs of feasibility requests and responses, ensuring timely communication with potential investigators.
- Supporting the senior site network personnel in preparing feasibility reports and questionnaire development.
Medical degree/ PhD or Master’s degree
To succeed in this role, you should possess a medical degree or a relevant advanced degree with 1-3 years of experience in practical healthcare or clinical research. A thorough understanding of ICH-GCP guidelines, local regulatory requirements, and the ability to establish professional relationships are essential.
2. Trial Master File Specialist
The Trial Master File Specialist position is critical to the efficient management of clinical trial documentation. As a TMF Specialist, your key duties will include:
- Reviewing, classifying, and processing TMF documents for multiple studies in compliance with organizational SOPs.
- Supporting study setup, maintenance, and closure activities related to TMF.
- Conducting periodic quality checks and preparing TMF status reports while ensuring compliance with regulatory requirements.
- Acting as a liaison between project teams and sponsors regarding TMF documentation.
B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences
Candidates for this role should have a Bachelor’s degree in a scientific discipline or equivalent experience, with a minimum of five years in clinical research or eTMF management. Familiarity with the Trial Master File Reference model and best practices in records management is highly desirable.
Why Biorasi?
At Biorasi, we believe that our people are our greatest assets. We encourage a culture of innovation and professional growth, allowing employees to develop their careers while maintaining a healthy work-life balance. By joining our team, you will be at the forefront of clinical research, contributing to meaningful projects that hold the potential to change lives.
Key Benefits:
Engaging projects that allow you to make a real impact in the healthcare industry.
Competitive salary and comprehensive health benefits.
Opportunities for professional development and advancement in a global organization.
Supportive work environment emphasizing teamwork and collaboration.
Application Link For Trial Master File Specialist
Application Link For Site Network Specialist (Global Feasibility)
