28 Ichgcp Guidelines Jobs

As a CRA II/ Sr CRA I (Oncology) based in Mumbai for Syneos Health, your role is crucial in ensuring the integrity of clinical research studies by monitoring data and processes. Your responsibilities will include: - Having a minimum of 3-5 years of monitoring experience - Experience in therapeutic areas like Oncology, Hematology, Cardiology, Neuropsychiatry, Rare Disease, and Immunology - Candidate from Mumbai location with a Pharma background - Performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) compliance - Verifying the process of obtaining informe...

As a Clinical Trial Assistant (CTA) at Clinogenesis Research Organisation, your role will involve supporting clinical operations and contributing to the successful execution of clinical studies. You will assist with documentation, site coordination, communication, and study tracking to ensure compliance with regulatory and study requirements. Key Responsibilities: - Maintain and update Trial Master File (TMF/eTMF) and study documentation. - Assist in preparation, review, and distribution of study-related documents (ICFs, logs, reports, etc.). - Track clinical supplies, site progress, and subject enrollment. - Support the scheduling of clinical trial meetings, monitoring visits, and training ...

You are currently seeking a full-time office-based Experienced Study Start-up Submissions Coordinator to join the Clinical Operations team in Mumbai, India. As a vital part of the team, your role will involve accomplishing tasks and projects crucial to the company's success. If you are looking for an exciting career opportunity to utilize your expertise and further develop and grow your career, this is the perfect opportunity for you. Responsibilities: - Perform activities within the country leading to the activation of investigative sites in all phases of clinical trials. - Prepare, review, and submit documents to Regulatory Agencies. - Communicate with global study teams and personnel rega...

As a Regulatory Specialist, you will be responsible for the following key responsibilities: - Bachelor's degree in Life Sciences, Clinical Research, Science, Healthcare Administration, or a related field. - 25 years of regulatory experience in clinical research or pharmaceutical environments. - CITI certifications (GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC) required within two weeks of hire; training will be provided. - Familiarity with IRB submissions, study start-up activities, and regulatory document maintenance. - Proficiency with CRIO (Clinical Research IO) or similar electronic platforms used for eISF and study documentation. - Experience with Clinical Trial Management Systems (CTMS), El...

As a Research Coordinator at Jothydev's Diabetes Research Centre, your role will involve assisting in trial management and site coordination, maintaining Trial Master Files (TMF) with proper documentation, and ensuring regulatory compliance. You will also be responsible for drug storage, dispensing, and accountability, as well as supporting patient enrollment and clinical trial material logistics. Additionally, you will schedule meetings, prepare agendas and minutes, demonstrating your technical and soft skills including knowledge of ICH-GCP guidelines, proficiency in Microsoft Office and clinical trial software, and strong organizational and communication abilities. Qualifications required ...

As a Document Management Specialist at our company, you will be responsible for maintaining both paper and electronic documents for the electronic Trial Master File (eTMF) in compliance with regulatory, legal, and relevant guidelines. Your key responsibilities will include: - Storing and retrieving documents as needed from archives or long-term storage. - Ensuring the security of the document storage area. - Collecting, indexing, and storing newly received paper documents. - Utilizing electronic imaging and quality-control management applications to maintain the electronic trial master file according to Good Clinical Practices and other relevant guidelines. - Assisting in the migration of pa...

As a fresher in the field of research and regulatory affairs, you will be responsible for completing appropriate role-specific training to perform job duties. Under supervision, you will assist in various administrative tasks to support team members in project execution. This may include running system reports, maintaining meeting minutes, preparing and distributing status reports, creating and managing study documents, and more. - Assist in various administrative tasks to support team members in project execution - Run system reports, maintain meeting minutes, prepare and distribute status reports - Create and manage study documents Your role will also involve updating and maintaining syste...

As a Medical Scientist at Syneos Health in Shanghai/Beijing, you will play a crucial role in developing medical plans and supporting data analysis to ensure successful project milestones. Your responsibilities will include: - Collaborating with the Medical Director to develop medical plans such as the Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan. Engaging with external experts to gather necessary medical/scientific input. - Conducting regular and ad-hoc medical review of data listings, analyzing data patterns, and identifying risks. Authoring medical data queries and overseeing query responses. - Supporting the Medical Director in various tasks including pat...

As a Study Start-Up Clinical Research Associate (SSU CRA) at Novartis in Mumbai, India, you will play a crucial role in ensuring efficient and compliant trial start-up activities at clinical sites. Your responsibilities will include site selection, preparation, and activation for Phase IIV clinical trials. You will act as the primary liaison between the sponsor and the site during the start-up phase, ensuring all regulatory, ethical, and operational requirements are met to achieve site readiness. - Lead and execute site selection and start-up activities, from country allocation to site greenlight. - Serve as the main point of contact for trial sites during start-up, including IRB/IEC and Hea...

As a Clinical Trial Assistant, you will play a crucial role in the planning, design, and execution of clinical trials involving Ayurvedic and/or integrative therapies. Your responsibilities will include: - Assisting in screening, recruiting, and monitoring clinical trial participants - Ensuring accurate documentation of case reports and informed consent in compliance with ICH-GCP guidelines - Collaborating with investigators, coordinators, and sponsors on trial-related activities - Reviewing and ensuring the accuracy of medical and treatment data collected during trials - Monitoring patient safety and promptly reporting adverse events - Maintaining regulatory and ethical compliance throughou...

Role Overview: As a Senior Clinical Data Programmer, your core responsibility is to understand complex business requirements and identify strategic opportunities to drive efficiency and value through data. You will leverage advanced programming languages, scripts, and software tools to perform sophisticated data extraction, transformation, and validation, ensuring the highest standards of data integrity and consistency across critical projects. Key Responsibilities: - Architect and maintain complex programs, ensuring robust data integrity and accuracy. - Create advanced programs for generating detailed reports and summaries of clinical trial data. - Design and implement advanced software to ...

As a Clinical Operations Manager/Senior Clinical Operations Manager at Novotech, you will play a crucial role in supervising, leading, and managing the Clinical operation team to ensure the successful conduct of clinical trials in adherence to ICH-GCP guidelines, local regulatory requirements, Novotech/client SOPs, and the Project Agreement. Key Responsibilities: - Act as the Novotech ambassador for the India team, leading discussions on India Clinical services capabilities in BDM and client meetings. - Drive new business for Novotech India Clinical Services in collaboration with Business Development. - Serve as a line manager for assigned CRAs, IHCRAs, RSAs, and mentor clinical operations s...

As a Senior Clinical Data Manager I at Allucent, you will be responsible for leading various data management activities within the Data Management (DM) department. Your role will involve managing data deliverables from database design to locking, ensuring the quality and completeness of clinical data meet regulatory requirements. Additionally, you will provide expertise in data management areas, develop departmental processes, and support in Request for Proposals (RFPs). Your key responsibilities will include: - Being the primary contact for data management with internal and external parties - Planning and allocating required resources, managing tasks, timelines, and quality - Developing and...

Role Overview: As a Medical Safety Expert, your primary role will be to provide medical safety expertise to Sponsors of drugs, devices, and combination products during the post-marketing period. You will be responsible for undertaking the primary medical review of cases, updating and documenting case data, and assuming complete responsibility for assigned deliverables while maintaining quality, compliance, and productivity standards. Additionally, you will provide training and guidance to the case processing team on medical aspects of case processing. Key Responsibilities: - Undertake primary medical review of cases including assessment for seriousness, listedness/labeling, causality, advers...

Role Overview: As a Global Trial Manager, Clinical Operations at Sun Pharma, you will play a crucial role in the clinical development team based in Mumbai. Reporting to the Global Trial Leader, Clinical Operations, you will be responsible for assisting in the management of Sun Pharmaceuticals clinical trials globally, regionally, or at the complex local level. Your primary focus will be on overseeing the end-to-end clinical trial management process, including start-up, execution, close-out, and finalization of study reports. Your contributions will be essential in ensuring that all project tasks and timelines are on track. Key Responsibilities: - Oversight of CRO / other vendors and study ma...

Role Overview: As the Principal Investigator (PI) based in Noida, India, you will oversee the scientific, ethical, and regulatory aspects of clinical trials. Your crucial responsibilities include ensuring participant safety, protocol adherence, and data integrity throughout the trial process. Collaboration with sponsors, regulatory authorities, and internal teams will be essential to achieve successful trial outcomes. Key Responsibilities: - Serve as the lead medical expert for assigned clinical trials - Ensure compliance with ICH-GCP guidelines and local regulatory requirements - Oversee patient recruitment and informed consent processes - Document and report adverse events - Participate in...

In this role of CRA II/ Sr CRA I at Syneos Health based in Mumbai with a focus on Oncology, you will play a crucial part in overseeing and ensuring the integrity of clinical research studies by monitoring data and processes. Your responsibilities will include conducting site qualification, site initiation, interim monitoring, site management activities, and close-out visits. Additionally, you will be responsible for ensuring regulatory, ICH-GCP, and protocol compliance, as well as evaluating site performance and providing recommendations. You will also be involved in tasks such as assessing subject/patient safety, conducting source document review, and ensuring site compliance with electroni...

Premier Research is seeking an Associate Director, TMF Process, Systems, and Training to join the Pharmacovigilance and Records Management team. In this role, you will play a pivotal part in assisting biotech, medtech, and specialty pharma companies in translating groundbreaking ideas and scientific advancements into new treatments. Your work will directly impact saving and enhancing lives, highlighting the invaluable contribution of our team members towards achieving success. As an essential member of our team, you will be instrumental in driving the improvement of TMF processes, systems, and training within Global Records Management (GRM). Collaborating with Departmental Leadership, you wi...

As a Clinical Research Associate II (Sponsor dedicated) in Athens Homebase at Syneos Health, you will play a crucial role in ensuring site compliance with regulatory guidelines and protocol requirements. Your responsibilities will include performing site qualification, initiation, monitoring, management activities, and close-out visits either on-site or remotely. You will assess site performance, provide recommendations, and escalate any serious issues to the project team promptly. Your attention to detail will be essential as you verify the informed consent process, assess factors affecting subject safety, and review clinical data for accuracy and completeness. You will conduct source docum...

You will be joining our Clinical Operations team in India, Mumbai as a full-time office-based Experienced Study Start-up Submissions Coordinator. Your role will be crucial in accomplishing tasks and projects that are essential for the success of our company. If you are seeking a rewarding career where you can utilize your expertise and further develop and grow professionally, this opportunity is perfect for you. At Medpace, we foster a culture of expertise and empowerment, allowing our teams to leverage their unique talents and experiences to approach research and problem-solving assertively, thereby supporting our business partners effectively. Our employees embody our values and commitment...

As the Manager of Data Management at eClinical Solutions, you will be responsible for providing operational leadership in overseeing end-to-end data management services for designated projects and studies in modern clinical data management. Your role will involve collaborating closely with clients and vendors to ensure timely delivery of high-quality outputs within budgetary constraints. You will strategically integrate advanced technologies and data science techniques to enhance the efficiency and quality of clinical trials within our organization, aiming to improve operational effectiveness and scientific rigor in data management practices. Your key tasks and responsibilities will include:...

As a Clinical Trials Assistant, you will play a crucial role in supporting various aspects of clinical trials. Your responsibilities will include assisting in site selection, initiation, monitoring, and close-out visits for clinical trials to ensure their successful implementation. It will be your responsibility to ensure that all clinical trials are conducted in compliance with the protocol, ICH-GCP guidelines, and regulatory requirements. You will be tasked with maintaining accurate and proper documentation of all trial activities and reporting findings effectively. Your role will also involve supporting data verification by meticulously comparing source data with Case Report Forms (CRFs)....

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*). The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, you will manage, coordinate, review, and approve DM deliverables from database design & set-up, through cleaning and reporting to database locking. It is crucial to ensure that the completeness, accuracy, and consistency of clinical data meet the...

As a Medical Safety Expert, your primary responsibility will be to provide medical safety expertise to Sponsors of drugs, devices, and combination products during the post marketing period. This will involve undertaking the primary medical review of cases, including assessing seriousness, listed/labeling, causality, adverse event coding, and narrative review. You will be required to update and document case data daily, provide training and guidance to the case processing team on medical aspects, and ensure all assigned deliverables meet quality, compliance, and productivity standards. Additionally, you will perform secondary medical reviews and retrospective reviews to measure the quality of...

As the Principal Investigator (PI) based in Noida, India, you will play a crucial role in overseeing the scientific, ethical, and regulatory aspects of clinical trials. Your responsibilities will include ensuring participant safety, protocol adherence, and data integrity throughout the trial process. You will collaborate with sponsors, regulatory authorities, and internal teams to achieve successful trial outcomes. Your key responsibilities will involve serving as the lead medical expert for assigned clinical trials, ensuring compliance with ICH-GCP guidelines and local regulatory requirements, overseeing patient recruitment and informed consent processes, documenting and reporting adverse e...