8.0 - 12.0 years

0 Lacs

haryana

On-site

As a Project Director for the Stem Cell Therapy project, you will be responsible for leading the program from lab to clinic, with a vision to guide the project from bench-to-bedside. Your role will involve coordinating cross-functional teams, including scientists, clinicians, regulatory, QA, and manufacturing staff. You will be expected to manage budgets, timelines, and risk mitigation plans effectively, ensuring the successful progression of the project. Key Responsibilities: - Lead or coordinate cross-functional teams involved in stem cell or regenerative medicine research - Manage budgets, timelines, and risk mitigation plans for the project - Work with internal and external stakeholders ...

Posted 2 days ago

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Experienced Study Start up Submissions Coordinator Medpace

4.0 - 8.0 years

0 Lacs

navi mumbai, maharashtra

On-site

As an Experienced Study Start up Submissions Coordinator at Medpace, you will play a crucial role in the activation of investigative sites for clinical trials in India Mumbai. Your expertise will be utilized to prepare, review, and submit documents to Regulatory Agencies, ensuring compliance with applicable regulations and guidance documents. You will be the main contact for Ethical and Regulatory submission-related activities, providing guidance to global study teams and sponsors on changing regulations and compliance requirements. **Key Responsibilities:** - Perform activities within the country leading to site activations in clinical trials - Communicate with global study teams and person...

Posted 1 month ago

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Senior Regulatory Start Up Associate Novotech

3.0 - 7.0 years

0 Lacs

karnataka

On-site

As a Senior Regulatory Start-Up Associate at the company, your primary responsibility will be to plan, prepare, and review country and site level ethics and regulatory authority applications and submissions during project start-up. Your role is crucial in ensuring compliance with ICH-GCP and local regulatory requirements to facilitate timely clinical trial approval. Your key responsibilities will include: - Serving as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. - Providing expertise and guidance to RSM and/or PM on country and local regulations and practices, staying updated on developments and chan...

Posted 1 month ago

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Study Start up Submissions Coordinator Medpace

4.0 - 8.0 years

0 Lacs

navi mumbai, maharashtra

On-site

You will be joining our Clinical Operations team in India, Mumbai as a full-time Experienced Study Start-Up Submissions Coordinator. Your role will be crucial in completing tasks and projects essential to our company's success. If you are looking for a rewarding career where you can utilize your expertise and further develop professionally, this opportunity is for you. At our company, we value expertise and empower our teams to leverage their unique skills and experience in research, problem-solving, and supporting our business partners. Our employees embody our values, work diligently, meet high expectations, and are rewarded with engaging projects, career progression, and exposure to globa...

Posted 2 months ago

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Associate Director Biostatistics Novartis

6.0 - 10.0 years

0 Lacs

hyderabad, telangana

On-site

You will be responsible for providing highly advanced expert support and functional and technical leadership to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. Your main tasks will include developing and applying biostatistics and programming methods to ensure valid conclusions, as well as providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. Additionally, you may also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics, and reporting of clinical trial data, you may indepen...

Posted 3 months ago

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