Study Start-up Submissions Coordinator at Medpace

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Study Start-up Submissions Coordinator at Medpace

Location: Navi Mumbai
Experience: 1 Year
Salary: ₹4 – 5 Lacs Per Year
Education: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Life Sciences
Application Mode: Online
Skills: Time management, Flexibility, Problem-solving, Work/Life Balance


About Medpace

Medpace is a global leader in clinical research, providing comprehensive services to accelerate the development of innovative medical treatments. With over 30 years of experience, Medpace supports biotechnology, pharmaceutical, and medical device industries in conducting Phase I-IV clinical trials. Headquartered in Cincinnati, Ohio, Medpace operates in more than 40 countries with a team of over 5,000 professionals. The company is dedicated to ensuring safe and effective therapeutics for patients while fostering a work environment that promotes growth and work-life balance. Study Start-up Submissions Coordinator at Medpace

Position Overview: Study Start-up Submissions Coordinator

Medpace is looking for a Study Start-up Submissions Coordinator to join its Clinical Operations team in Navi Mumbai, India. This role is crucial in the initiation of clinical trial sites, ensuring that regulatory submissions adhere to local and international standards. As part of the global clinical trials team, you will manage the documentation and communication necessary to get clinical trial sites operational. This position offers a challenging yet rewarding environment where you’ll be involved in significant projects and have opportunities for career growth. Study Start-up Submissions Coordinator at Medpace

Key Responsibilities

Study Start-up Submissions Coordinator at Medpace

  • Site Activation Management: Oversee the activation of investigative sites for clinical trials across all phases.
  • Document Preparation and Submission: Prepare, review, and submit essential clinical trial documents to Ethics Committees and Regulatory Authorities.
  • Communication and Reporting: Maintain clear communication with global study teams to provide progress updates and ensure timely submissions.
  • Risk Management: Identify potential risks to site activation and proactively implement solutions to ensure smooth operations.
  • Regulatory Guidance: Offer regulatory submission guidance to global teams and sponsors, ensuring compliance with ICH-GCP and other regulatory guidelines.
  • Monitoring and Documentation: Track submission timelines and ensure all necessary documents are maintained for audits and inspections.
  • Regulatory Compliance: Ensure all submissions align with local and global regulatory standards, including ICH-GCP guidelines.
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Why This Role is Exciting

This position at Medpace offers an excellent opportunity for professionals looking to build a career in clinical operations within a dynamic and global company. You’ll be involved in pivotal clinical trial processes, contributing directly to the activation of trial sites that play a significant role in the development of life-saving therapeutics.

Medpace provides not just exciting projects but also a balanced work environment with competitive benefits and room for professional growth. The hybrid work model ensures you have flexibility, making it easier to maintain a healthy work-life balance while contributing to meaningful advancements in healthcare. Study Start-up Submissions Coordinator at Medpace

Required Qualifications and Skills

Study Start-up Submissions Coordinator at Medpace

  • Educational Background: A Bachelor’s or Master’s degree in a science-related field such as Pharmacy, Life Sciences, or an equivalent mix of education and experience.
  • Experience: At least one year of experience in regulatory submissions within a CRO, pharmaceutical company, or clinical investigative site.
  • Regulatory Knowledge: Hands-on experience in preparing and submitting documents to Ethics Committees and Regulatory Authorities, with a solid understanding of ICH-GCP guidelines and regulatory requirements.
  • Technical Proficiency: Experience with Microsoft Office tools and regulatory submission platforms.
  • Communication and Organization Skills: Strong verbal and written communication skills in English, along with excellent organizational abilities to manage multiple tasks and timelines.
  • Problem-solving and Adaptability: Proven ability to solve problems related to regulatory submissions and site activation, as well as to adapt to changing regulatory landscapes.
    Study Start-up Submissions Coordinator at Medpace

Skills You Need to Succeed

  • Attention to Detail: Ensuring all regulatory documents are error-free and submitted in compliance with guidelines.
  • Project Management: Ability to juggle multiple submissions and meet tight deadlines while keeping track of all necessary documentation.
  • Collaboration: Work effectively with internal teams, global study groups, and investigative sites to ensure site activation is completed on time.
  • Problem-solving: Quick thinking to address risks or issues that may arise during the submission and activation phases.
  • Adaptability: Stay ahead of the curve by adapting to evolving regulatory changes and requirements.
    Study Start-up Submissions Coordinator at Medpace
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How to Apply

If you have the qualifications and are eager to take on a challenging yet fulfilling role, apply now to join Medpace’s global clinical operations team in Navi Mumbai. You’ll be part of a company that is at the forefront of clinical research, dedicated to making a real difference in patients’ lives worldwide.

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