31 Ich Gcp Jobs

We are Growing ! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization. Biorasi is looking for top performers who are as passionate about clinical research as we are clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry. Your role: Act as a primary or backup Medical Monitor for the assigned cli...

You will be responsible for the following tasks: - Entering information into PVG quality and tracking systems for receipt and tracking ICSR as required - Assisting in the preparation of project plans such as Safety Management Plan - Performing set-up, delivery, and close-out of safety and pharmacovigilance projects - Processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triageing ICSRs and evaluating ICSR data for completeness, accuracy, and regulatory reportability - Entering data into safety database - Coding events, medical history, concomitant medications, and tests - Compiling complete narrative summaries - Assessing information t...

Support Clinical research and clinical supplies projects in functional and software areas Responsibilities include: Review & analyze project/study requirements Define and document the functional requirements mapping to business requirements into required documents (like specifications, user acceptance plans, test plans, etc) Propose clinical solutions to software development teams Participate in pre-project documents for the approved projects and any related documents Involve extensively in reviewing and testing clinical systems acting as subject expert from study perspective Write testing scenarios and impact scenarios for study changes to clinical systems Develop workflow and process diagr...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized ...

Responsible for planning and delivery of European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role. Key Accountabilities Operations Management: Engage with Regulatory Affairs functional representatives to plan the Clinical Trial Application (CTA) for any one up and coming clinical trial that involves EU countries Engage with Clinical Trial Management functional representatives to determine key study milestones and country allocatio...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Role Overview: As a GBS TMF Co-Ordinator (eTMF-electronic Trial Master File Coordinator) at our Bangalore location, you will provide day-to-day support for the preparation and management of TMF documents before uploading and indexing in the eTMF system. Your role is crucial in ensuring the accuracy and completeness of clinical documentation, contributing to inspection-readiness and compliance with global regulatory requirements. You will work collaboratively with clinical project teams to support smooth TMF operations. Additionally, you will be responsible for managing and maintaining the AZ study-specific TMF index, including EDL updates and records management in the eTMF platform. Your rol...

As a Site Activation Specialist II at Syneos Health, your role will involve ensuring quality deliverables at the country level, following project requirements, and applicable country rules. You will work within forecasted submission/approval timelines, track milestone progress, and investigate any delays with clear rationale. It will be your responsibility to monitor basic financial aspects of the project, escalate discrepancies, review and comply with Standard Operating Procedures (SOPs), and support continuous improvement of quality in all Site Start-Up (SSU) components. Key Responsibilities: - Ensure quality deliverables at the country level - Follow project requirements and applicable co...

As a Safety & PV Specialist II at Syneos Health, you will play a crucial role in ensuring the safety and pharmacovigilance of projects by performing various tasks. Your responsibilities will include: - Entering information into PVG quality and tracking systems for receipt and tracking of ICSRs as required - Assisting in the preparation of project plans such as Safety Management Plan - Performing set-up, delivery, and close-out of safety and pharmacovigilance projects - Processing ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans - Triaging ICSRs, evaluating data for completeness, accuracy, and regulatory reportability - Entering data into the s...

Title - Senior Manager - TMF Team Lead Work Location: Manyata Tech Park, Bangalore, India Work Schedule: Three days on-site, two days remote (3/2) Work Hours: 9 am to 6 pm IST or 2 pm to 11 pm IST basis business needs (Transport available as per company policy) Career Level: E - Team Lead About Role The GBS TMF Team Lead is responsible for the strategic oversight, coordination, and leadership of the GBS TMF Services, ensuring high standards in Trial Master File management and inspection readiness for all assigned clinical trials. This role supervises TMF Managers, and Coordinators, fosters cross-functional collaboration, implements process improvements, and ensures compliance with global reg...

Site Name: Bengaluru Luxor North Tower Posted Date: Oct 21 2025 Job Purpose The Associate Director, Team Lead Integrated System Support is responsible for managing a team that supports or owns clinical business systems throughout their lifecycle. This includes ensuring systems owned or supported by the team are compliant, reliable, efficient, and user-friendly. Key Responsibilities For systems assigned to the team lead's team: Reliable, Compliant & Fit-for-Purpose System Landscape: Ensure systems comply with relevant external and internal guidelines, regulations and policies and that adequate documentation is maintained, archived and retrievable that demonstrate that systems are reliable, co...

As an Officer/Sr. Officer in the Consumer Research Department at our company based in Ahmedabad, your role involves: - Identifying and qualifying potential investigators for research studies. - Collecting necessary documents to assess site/investigator feasibility and obtain approval from authorities. - Training the site study team, maintaining essential documents, and overseeing startup activities and site initiation. - Conducting monitoring visits to ensure compliance with study management, protocol, and other requirements at all assigned sites. - Performing source document verification as per the monitoring plan to maintain accurate and up-to-date trial records. - Coordinating with labs a...

Site Name: Warsaw Rzymowskiego 53, Bengaluru Luxor North Tower Posted Date: Sep 29 2025 GSK's success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Job Purpose: The Director Process Management will be accountable fo...

Excelya, one of the leading independent CRO in Europe, is a people-centered Contract Research Organization (CRO) committed to providing a personal and authentic experience within a young, ambitious health company. With a team of 900 Excelyates, we are on the path to becoming the clinical research leader in Europe. Our unique one-stop provider service model offers full-service, functional service provider, and consulting, allowing our Excelyates to evolve through a diverse array of projects. We collaborate with preeminent experts to advance scientific, managerial, and human knowledge for the improvement of the patient journey. As a Clinical Data Manager with Excelya, you will be responsible f...

As a Safety & Pharmacovigilance Specialist I at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. You will be responsible for entering information into PVG quality and tracking systems, processing ICSRs according to SOPs, and ensuring completeness and accuracy of ICSR data. Additionally, you will be involved in coding events, medical history, and conducting literature screening for safety. Key Responsibilities: - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required - Assist in processing ICSRs according to SOPs and safety plans - Evaluate ICSR data...

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description: OBJECTIVES/PURPOSE : Lead study operational strategy and planning and oversee execution of clinical studies for the assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan (CDP). In close collaboration with Clinical Operations Program Lead (COPL) and Clinical Study Manager (CSM) Responsible for ...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Site Name: Warsaw Rzymowskiego 53, Bengaluru Luxor North Tower Posted Date: Sep 17 2025 GSK's success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Job Purpose: The Director Process Management will be accountable fo...

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to suppor...

As a Site Activation Specialist I at Syneos Health in Beijing/Shanghai, you will be responsible for ensuring the quality of deliverables at the country level, adhering to project requirements and applicable country rules under the oversight of the SSU Country Manager. Your role will involve working within forecasted submission/approval timelines, tracking milestone progress in real-time, and providing clear rationale for any delays while assisting in developing contingency plans to mitigate impacts. You will also monitor basic financial aspects of the project, escalate discrepancies promptly, and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) while keeping train...

As a Regional Submission Manager - Sponsor-dedicated with CTIS experience at Syneos Health, you will play a crucial role in driving regional submission management strategy and activities for assigned protocols. You will collaborate with major functional areas, including SSU and Study Management, regarding essential core documents and local documentation needed from relevant supplier lines across both HA and EC submission and translation processes. Your responsibilities will include partnering with study teams to manage required regulatory activities, standards, and deliverables associated with CTA submission development. You will be responsible for authoring Annex I and completing relative a...

As a Safety & PV Specialist II at Syneos Health, you will play a crucial role in entering information into PVG quality and tracking systems for receipt and tracking of ICSR as required. You may also assist in preparing project plans such as Safety Management Plan and perform set-up, delivery, and close-out of safety and pharmacovigilance projects. Your responsibilities will include processing ICSRs according to SOPs and project-specific safety plans, triaging ICSRs, evaluating data for completeness and accuracy, and entering data into safety databases. Additionally, you will code events, medical history, concomitant medications, and tests, compile complete narrative summaries, and follow up ...

As a Site Activation Specialist at Syneos Health in Shanghai or Beijing, you will be responsible for ensuring the quality of deliverables at the country level while adhering to project requirements and applicable country rules under the oversight of the SSU Country Manager. You will work within the forecasted submission/approval timelines, track milestone progress, and provide clear rationale for any delays while assisting with contingency plans to mitigate impacts. Monitoring basic financial aspects of the project and ensuring compliance with SOPs and WIs will also be part of your responsibilities. Your role will involve submitting essential documents to the Trial Master File (TMF) as per C...