5 Ich Gcp Jobs

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 understanding of clinical data standards, protocol interpretation, and the ability to build high-quality, compliant EDC databases. As a Programmer Analyst, you will play a crucial role in supporting the end-to-end development of clinical databases and ensuring data integrity throughout the trial lifecycle. Your responsibilities will include interpreting clinical trial protocols to design eCRFs and build databases using Medidata RAVE, InForm, Central Designer, or Veeva Studio. You will be responsible for configuring systems, implementing edit checks, dynamic rules, and custom functions (C# for RAVE) based on DVS. Additionally, you will conduct technical and functional reviews, support Sponsor Acceptance Testing (SAT), and ensure accuracy across all database components. You will also manage protocol amendments, metadata updates, lead ICRM/SAM meetings, and resolve issues in QC, UAT, and production environments. Handling migrations, RFCs, and post-go-live activities, generating sponsor reports (JReview, SAS, BOXI), acting as DB Coordinator across trials, and mentoring junior team members will also be part of your role. Key Requirements: - 3 to 5 years of hands-on experience with at least one EDC platform such as Medidata RAVE, InForm, Central Designer, or Veeva Studio (combination preferred). - Proficiency in eCRF design, edit checks, dynamic rules, and custom functions (e.g., C# for RAVE). - Solid understanding of clinical trial protocols, DVS interpretation, CDPS/SDV strategy, CRF annotation, and post-go-live activities, including migrations and RFCs. - High attention to detail with strong adherence to ICH GCP and clinical data standards. - Excellent written and verbal communication skills for effective team and sponsor collaboration. - Educational background in BE/B.Tech, M.Sc./MCA, or B.Sc./BCA in Computer Science or a related stream with consistent academic performance of 60% or above in 10th, 12th, and graduation.,

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 generating timely and accurate expedited reports in compliance with regulatory requirements. Your role will also involve maintaining safety tracking for assigned activities, performing literature screening and review for safety, drug coding, and MedDRA coding as required. You will validate and submit xEVMPD product records, manually recode un-recoded product and substance terms from ICSRs, identify and manage duplicate ICSRs, and conduct activities related to SPOR/IDMP. Furthermore, you will ensure the submission of all relevant documents to the Trial Master File and the Pharmacovigilance System Master File, while maintaining compliance with SOPs, global regulations, and guidelines. You will foster professional relationships with project team members, participate in audits as required, and apply safety reporting regulatory intelligence to all safety reporting activities. To excel in this role, you should possess a Bachelor's Degree in life science, registered nurse, pharmacist, or an equivalent combination of education and experience. A minimum of 3 years of experience in ICSR is required, along with a good understanding of clinical trial processes, ICH GCP, GVP, and safety regulations. Proficiency in Microsoft Office Suite, excellent communication skills, the ability to work independently and in a team environment, and strong organizational skills are essential. Join Syneos Health, a company dedicated to accelerating customer success by translating insights into outcomes and creating a diverse and inclusive workplace where everyone feels like they belong. If you are passionate about making a difference in the lives of others, apply now and be a part of our team that is committed to changing lives through innovative solutions.,

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 site selection, initiation, routine monitoring, and close-out visits. Monitoring patient enrollment to meet recruitment targets and project timelines will be crucial at both site and country levels. You will be responsible for source data verification, resolving data queries, and conducting ongoing reviews to ensure data quality and compliance with Risk Based Monitoring practices. Timely reporting and follow-up of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations will also be part of your duties. Acting as the main communication channel between the Sponsor and the site, you will serve as a point of contact for in-house support services and vendors. Proper handling, accountability, and reconciliation of Investigational Product(s) and study supplies will be under your supervision. Additionally, you will review essential documents at the site level and ensure the reconciliation of study OSF/TMF at the site and/or country level.,

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 supervision of senior staff, you will be involved in data cleaning, review, discrepancy management, and reconciliation activities on assigned studies. Additionally, you will collaborate with the Lead Data Manager, generate study metrics and reports, and participate in study documentation archiving. Excelya is currently seeking a Full Service Provider role of Clinical Data Manager I (CDMI) based in Bangalore, India. The role requires a candidate with a Bachelor's degree in a Scientific discipline, preferably with at least one year of experience as a Data Manager or relevant expertise. Knowledge of ICH GCP guidelines, clinical trial databases, data flow, and proficiency in office computer applications are essential requirements for this position. Effective communication skills, both verbal and written, along with a commitment to professionalism, ethics, and compliance, are key attributes we are looking for in potential candidates. The successful candidate for the role of Clinical Data Manager at Excelya should be fluent in both the local language and English. This full-time position is located in Bangalore and offers an opportunity to contribute to the field of Clinical Research. If you are passionate about making a difference in the healthcare industry and meet the mentioned requirements, we encourage you to apply for this exciting opportunity. If you are interested in this position, please reach out to Bhavya Reddy, HR Manager, for further details.,

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,