Medpace Clinical Research Vacancies in Mumbai

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Job Details

Position Name:

Study Start-up Submissions Coordinator

Organization:

Medpace

Qualification:

• B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences

Experience:

• 1 to 2 Years

Salary:

• ₹4L – ₹7L per year

Location:

• Mumbai, India

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Job Description

Medpace, a global leader in clinical research, is seeking a Study Start-up Submissions Coordinator to join our Clinical Operations team in Mumbai. This full-time, office-based role is essential to ensuring the successful activation of investigative sites in all phases of clinical trials. The position offers an exciting opportunity to contribute to the advancement of medical research and development while growing your career within a supportive and dynamic environment.

Responsibilities:

• Site Activation: Coordinate activities within the country to activate investigative sites across various phases of clinical trials.
• Regulatory Submissions: Prepare, review, and submit necessary documentation to Regulatory Agencies.
• Communication: Maintain clear communication with global study teams and personnel regarding study progress.
• Risk Management: Identify risks related to site activations and implement effective mitigation strategies.
• Ethical and Regulatory Guidance: Provide expertise to global study teams on ethics and regulatory submissions.
• Documentation: Review and finalize essential documents required for site activation.
• Main Contact: Serve as the primary contact for Ethical and Regulatory submission-related activities.
• Site Interaction: Engage directly with investigative sites during the study start-up and activation process.
• Regulatory Compliance: Ensure all submissions comply with applicable regulations and guidelines.
• Sponsor Advisement: Advise sponsors on changing regulations and compliance requirements.
• Tracking and Filing: Track submissions and ensure the timely filing of documents.

Required Qualifications:

• Educational Background: Bachelor’s degree in the sciences or an equivalent combination of education and experience.
• Industry Experience: At least one year of relevant experience in a CRO, pharmaceutical company, or investigative site.
• Skills:
• Strong organizational and communication skills.
• Proficiency in Microsoft® Office.
• Knowledge of ICH – GCP guidelines and other regulatory guidelines.
• Hands-on experience with preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies.
• Excellent command of the English language.

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Medpace Overview

Medpace is a full-service Clinical Contract Research Organization (CRO) that provides Phase I-IV clinical development services to biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through our scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across major areas including:

• Oncology
• Cardiology
• Metabolic Disease
• Endocrinology
• Central Nervous System
• Anti-viral and Anti-infective

Headquartered in Cincinnati, Ohio, Medpace employs over 5,000 people across 40+ countries.

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Why Join Medpace?

People. Purpose. Passion.

Medpace is committed to making a difference in the lives of patients and families who face hundreds of diseases across key therapeutic areas. Our work has positively impacted countless lives over the past 30+ years, and we continue to strive for advancements that will benefit future generations.

Medpace Perks:

• Hybrid Work Options: Enjoy the flexibility of working from home, depending on the position and level.
• PTO Packages: Competitive paid time off packages.
• Employee Events: Company-sponsored appreciation events.
• Health and Wellness: Initiatives promoting employee health and wellness.
• Flexible Schedule: Options for a flexible work schedule.
• Career Growth: Structured career paths with opportunities for professional development.
• Compensation: Competitive salary and benefits package.

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How to Apply

If you are a motivated individual with a passion for clinical research and meet the qualifications outlined above, apply now to join our team at Medpace. Together, we can make a difference in the future of medicine.

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