Are you ready to take the next step in your career? Bristol Myers Squibb (BMS) is looking for a Study Startup Specialist in Mumbai, MH, to join our dynamic team. This role offers the unique opportunity to contribute to life-changing clinical trials that transform the lives of patients. If you are passionate about healthcare and are equipped with the necessary skills, we encourage you to apply.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients overcome serious diseases. Our commitment to scientific innovation, professional development, and inclusivity makes BMS a unique place to work. We thrive on diversity and offer an environment where every employee can play an integral role in our mission: “Transforming patients’ lives through scienceâ„¢.”
Job Description
As a Study Startup Specialist, you will be responsible for managing study start-up activities and ongoing documentation for clinical trials. You will act as the point of contact for local study teams and external stakeholders, ensuring that all necessary deliverables are met for successful trial milestones.
Key Responsibilities
- Manage study and site-level deliverables during study start-up and maintenance.
- Develop strategies for successful recruitment and timely delivery of study milestones.
- Prepare Investigator Sites by approving essential clinical trial and regulatory documents.
- Collaborate with local regulatory to submit documentation to Health Authorities and Ethics Committees.
- Review and approve informed consent forms (ICFs) and clinical trial packages (CTPs).
- Maintain the Trial Master File (eTMF) to ensure compliance with regulatory requirements.
- Provide expertise on country regulatory requirements, staying updated on evolving regulations.
- Support health authority inspections and audit preparations as needed.
Qualifications
- Bachelor’s degree in life sciences or equivalent.
- Minimum of 2 years of industry-related experience.
- Thorough understanding of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
- Strong organizational, planning, and time management skills.
- Proficiency in verbal and written communication in English and local language.
- Ability to manage multiple priorities and perform critical thinking and risk analysis.
