5.0 - 9.0 years

0 Lacs

haryana

On-site

As a Lead Trial Manager (LTM) at the RCO unit, you will be responsible for the successful delivery of studies assigned to you. Your role will involve performing end-to-end study-related onsite and remote monitoring, ensuring quality data review, and managing essential documents for in-house studies within agreed timelines, budget, and quality standards. Your key responsibilities will include: - Ensuring that clinical trials are conducted at assigned sites in compliance with the protocol, local regulatory requirements, ICH GCP, and ethical standards - Acting as the primary communication point between SPIL and clinical trial sites for site management activities - Facilitating regulatory submis...

Posted 18 hours ago

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Clinical & Compliance Associate I Careplix

2.0 - 5.0 years

2 - 4 Lacs

kolkata

Work from Office

Oversees multiple regulatory specialists at clinical research sites, ensuring timely regulatory submissions, IRB documentation, compliance with evolving regulations, training oversight, audit coordination, and accurate maintenance of study records, while demonstrating advanced communication, leadership, multitasking, and regulatory knowledge.

Posted 1 week ago

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Clinical Research Associate Statistical Insights

2.0 - 6.0 years

0 Lacs

pune, maharashtra

On-site

The job involves providing clinical study start-up expertise and assisting the Lead CRA in preparing IRB submissions, including reviewing site-specific informed consent and assent forms. You will be responsible for tracking IRB submissions, collecting, reviewing, and processing essential documents, as well as identifying any issues that the site needs to address. Communicating updates needed to essential documents to the site is also an essential part of the role. Additionally, you will lead or support the setup and maintenance of the Trial Master File (TMF) and assist or participate in planning and conducting Investigators Meetings as necessary. This is a full-time position that offers the ...

Posted 3 weeks ago

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Manager, Regulatory Velocity Clinical Research, Inc.

4.0 - 8.0 years

0 Lacs

hyderabad, telangana

On-site

As a Manager at Velocity Clinical Research, you will play a crucial role in study start-up activities, focusing on regulatory compliance, source document delivery, and ensuring timely submission of key documents to facilitate study initiation. Your responsibilities will include managing a team of regulatory specialists, proactively addressing regulatory challenges, driving efficiency, and ensuring that regulatory submissions are completed promptly to avoid delays in study start-up. You will be involved in preparing study-specific protocol documents, informed consent forms, HIPAA authorizations, and other necessary materials for review by the Institutional Review Board (IRB). Additionally, yo...

Posted 1 month ago

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Clinical Research Manager InCommon

2.0 - 6.0 years

0 Lacs

haryana

On-site

As a Manager of Clinical Research at The Ayurveda Experience, you will be responsible for leading and managing clinical trials and research studies to ensure timely delivery, budget adherence, and compliance with regulatory standards. In this role, you will supervise research teams, collaborate with cross-functional departments, and provide strategic direction to achieve high-quality research outcomes that align with the company's mission. Your responsibilities will include planning, initiating, and overseeing clinical research projects from start to finish while ensuring adherence to protocols, timelines, budgets, and Good Clinical Practice (GCP) standards. You will lead and mentor clinical...

Posted 1 month ago

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