21 Ich Gcp Jobs

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...

As a Site Activation Specialist II at Syneos Health, you will be responsible for ensuring quality deliverables at the country level while following project requirements and applicable country rules under moderate oversight from the SSU Country Manager. You will work within forecasted submission/approval timelines, track milestone progress in the SSU tracking system, and investigate any delays with clear rationale and contingency plans as needed. Additionally, you will monitor basic financial aspects of the project, review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WI), and support the continuous improvement of quality in all Site Start-Up (SSU) components. Yo...

About ProcDNA: ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 300+ across 6 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey We are currently seeking a Programmer Analyst with a strong hands-on experience in EDC platforms such as Medidata RAVE, InForm, Central Designer, or Veeva Studio. The ideal candidate will possess a solid understandin...

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. Your responsibilities will include entering information into PVG quality and tracking systems, processing ICSRs according to SOPs, and evaluating ICSR data for completeness and accuracy. You will be responsible for triaging ICSRs, entering data into safety databases, coding events, medical history, and concomitant medications, as well as compiling complete narrative summaries. Additionally, you will be involved in identifying information to be queried, following up until resolution, and generatin...

As a Clinical Research Associate (CRA), you will play a key role in conducting Phase I-IV clinical BA/BE studies. Your primary responsibilities will involve monitoring and managing activities at clinical sites to ensure that project timelines and deliverables are achieved. Building strong relationships with clinical sites and investigators will be essential, along with assessing protocol and regulatory compliance based on local and federal requirements, ICH GCP guidelines, and PSI SOPs. Your focus will be on safeguarding subjects" rights, safety, and well-being, as well as maintaining data quality. Your tasks will include preparing, conducting, and reporting on various activities such as sit...

Excelya is a leading independent Contract Research Organization (CRO) in Europe, dedicated to providing a people-centered approach since its inception in 2014. As a part of the ambitious health company, with a team of 900 Excelyates, our unique service model offers a diverse array of projects, enabling professional growth and personal development. In collaboration with experts, Excelya aims to advance scientific knowledge and enhance the patient journey, striving to become the clinical research leader in Europe. As a Clinical Data Manager at Excelya, you will be responsible for executing Data Management tasks in compliance with regulatory standards and Client SOPs. Working under the supervis...

Data Management Manager Location: Bangalore Experience: 10+ years Education: Science Graduate Notice Period: Immediate Joiners preferred Skills: Data management, Line management, ICH GCP, data management FSP, clinical study, QC,