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3.0 - 5.0 years
0 Lacs
hyderabad, telangana, india
On-site
Key Responsibilities MuleSoft Development (Primary Focus): Design and implement API-led connectivity solutions using MuleSoft Anypoint Platform to integrate internal and external clinical systems. Develop and maintain scalable, reusable APIs and integration flows supporting clinical trial data exchange (EDC, CTMS, eTMF, IRT, and sponsor-facing platforms). Ensure MuleSoft integrations meet compliance standards such as HIPAA, 21 CFR Part 11, and GxP. Monitor, troubleshoot, and optimize MuleSoft integration performance and reliability. Stay current with MuleSoft platform updates, integration best practices, and clinical research technology trends. Automation & Orchestration Support Configure an...
Posted 2 weeks ago
2.0 - 14.0 years
0 Lacs
hyderabad, telangana
On-site
As a Clinical Supply Chain Support Specialist at Capgemini, your role involves providing operational support to Clinical Supply Chain Study Leaders for multiple studies across all phases (set-up, follow-up, closure). You will work independently and collaborate with cross-functional teams to ensure smooth supply chain operations and compliance with regulatory standards. Your responsibilities will include: - Prepare and track transfer orders. - Manage stock reconciliation and monitor destruction needs. - Perform quality checks and maintain inspection readiness. - Prepare documentation for labeling and shipments. - Archive documents in the electronic Trial Master File. - Communicate effectively...
Posted 3 weeks ago
10.0 - 15.0 years
15 - 22 Lacs
hyderabad
Work from Office
JoB Description GSSS (Global Study Supply Support) The role of the Global Study Supply Support (GSSS) is to provide support to the Clinical Supply Chain Study Leader (CSC SL) with minimal supervision. The GSSS works on iterative tasks during the set-up/follow-up/Closure phase of the clinical studies in phase I to IV. He/she works with several CSC SL and several studies. The expected knowledge described below are expected - Understanding of clinical trial design, protocols, regulatory requirements (GxP) - Understanding of clinical endpoints, patient randomization processes, study arms, dosing regimens, cohort management, stratification factors - Understanding of investigational product manage...
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
hyderabad, telangana
On-site
As a Global Study Supply Support (GSSS) in our company, you will play a crucial role in providing operational support to Clinical Supply Chain Study Leaders for multiple studies across all phases. Your responsibilities will include working independently and collaborating with multiple leaders and cross-functional teams, preparing and tracking transfer orders, managing stock reconciliation, performing quality checks, preparing documentation for labeling and shipments, monitoring needs for destruction, and archiving documents in the electronic Trial Master File. Your key responsibilities will involve supporting clinical supply chain operations for global studies, ensuring compliance with regul...
Posted 1 month ago
6.0 - 11.0 years
20 - 30 Lacs
hyderabad
Hybrid
Job Title: Global Study Supply Support (GSSS) Role Overview Provide operational support to Clinical Supply Chain Study Leaders for multiple studies across all phases (set-up, follow-up, closure). Work independently and collaborate with multiple leaders and cross-functional teams. Key tasks include: Preparing and tracking transfer orders. Managing stock reconciliation. Performing quality checks. Preparing documentation for labeling and shipments. Monitoring needs for destruction. Archiving documents in the electronic Trial Master File. Key Responsibilities Support clinical supply chain operations for global studies. Ensure compliance with regulatory standards and protocols. Maintain accurate ...
Posted 1 month ago
2.0 - 7.0 years
9 - 13 Lacs
hyderabad
Work from Office
The GSSS will report to the GSSS Team Leader (India) and interact with the Clinical Supply Chain stakeholders. Main responsibilities include: Common: Clinical Trial & Supply Knowledge Understandingof clinical trial design, protocols, regulatory requirements (GxP) Understandingof clinical endpoints, patient randomization processes, study arms, dosing regimens, cohort management, stratification factors Understandingof investigational product management in clinical trial including kit types, shelf life, IMP production plan, depot management, IMP distribution, IMP reconciliation, returns/destruction. Level 1 responsibilities: Create and manage transfers to depot in IRT, customize them in Sanofi ...
Posted 1 month ago
0.0 years
0 Lacs
delhi, india
On-site
Researcher Psychometric Assessments As an Assessment Researcher, the candidate will be responsible for developing and redesigning psychometric tools, conducting primary and secondary research, standardization studies, and creating technical manuals and research reports. They will be expected to stay up-to-date with global research on psychometrics and organizational behavior, lead thought leadership in the assessment space, and collaborate with business teams to develop assessment plans for new products. Taking full ownership of new tool development and redesigning of in-house psychometric tools. Having strong knowledge of research done in India and abroad on different aspects of psychometri...
Posted 2 months ago
5.0 - 8.0 years
4 - 8 Lacs
hyderabad, madhapur, ts
Work from Office
Key Tasks & Responsibilities: The IRT Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. Revises / develops the clinical study protoco...
Posted 2 months ago
5.0 - 9.0 years
0 Lacs
hyderabad, telangana
On-site
Role Overview: Working at Bristol Myers Squibb offers you a challenging, meaningful, and life-changing experience every day. You will be part of uniquely interesting work that transforms the lives of patients and your career. The opportunities for growth and thriving are exceptional in scale and scope, allowing you to take your career to new heights. Key Responsibilities: - Lead successful execution and on-time delivery of Interactive Response Technology (IRT) and support integrations with other clinical systems - Manage IRT projects as a strategic partner and single point of accountability for partner lines - Identify areas of process improvement and participate or lead these initiatives - ...
Posted 2 months ago
6.0 - 10.0 years
10 - 20 Lacs
noida
Remote
Position: Clinical Systems Specialist Overview: We are looking for a skilled Clinical Systems Specialist with strong, hands-on experience in Veeva Testing. This role focuses on testing and validation within the Veeva environment and supports various modules in the Veeva CDMS suite. While deep experience with eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms is not required, you should understand how they work within decentralized clinical trials (DCTs) and be comfortable working alongside these systems. Job Description: Key Responsibilities: Perform testing and validation activities within Veeva CDMS , including writing and executing test scri...
Posted 2 months ago
3.0 - 6.0 years
10 - 20 Lacs
chennai
Work from Office
Role & responsibilities Pursue specialization in specific areas of security operations, such as threat hunting, malware analysis, or digital forensics, through targeted training and hands-on experience. Utilize Splunk SIEM and CrowdStrike EDR tools to monitor, detect, and respond to security incidents. Develop and execute security monitoring strategies and initiatives, working closely with the SOC management team to align efforts with organizational goals. Create and maintain standard operating procedures (SOPs) to ensure consistent and effective security operations. Support Monitoring Team to take remote session with user for troubleshooting the user machines to remove malware. Lead the pre...
Posted 3 months ago
5.0 - 8.0 years
6 - 8 Lacs
hyderabad, madhapur
Work from Office
Key Tasks & Responsibilities: The IRT Project Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Project Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. Revises / develops the clinic...
Posted 3 months ago
3.0 - 5.0 years
0 - 0 Lacs
Hyderabad
Hybrid
Experience : 3 to 5 years Job Type: Hybrid Location: Hyderabad About the Role: We are seeking a highly skilled and motivated Machine Learning Specialist with a strong background in data science and a deep understanding of clinical supply chain/Supply Chain operations . This role will be instrumental in developing predictive models, optimizing logistics, and driving data-driven decision-making across our clinical trial supply chain. Key Responsibilities: Design, develop, and deploy machine learning models to forecast clinical supply needs, optimize inventory, and reduce waste. Collaborate with clinical operations, supply chain, and IT teams to identify data sources and integrate ML solutions ...
Posted 4 months ago
5.0 - 9.0 years
0 Lacs
chennai, tamil nadu
On-site
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...
Posted 4 months ago
6.0 - 11.0 years
15 - 25 Lacs
Noida
Remote
Job Description for the Current running requirement of Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT). Job Title: Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT) Experience: 6+ years Location: Remote 100% Work Timing: US EST time zone Job Description: - Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT) Overview: We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital...
Posted 4 months ago
5.0 - 8.0 years
4 - 8 Lacs
Hyderabad, Madhapur
Work from Office
Key Tasks & Responsibilities: The IRT Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. Revises / develops the clinical study protoco...
Posted 4 months ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
About Us Endpoint is an interactive response technology (IRT) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Raleigh-Durham, North Carolina with offices across the United States, Europe, and Asia. Position Overview The Senior Business Solutions Architect is responsible for the creation and management of the requirements a...
Posted 4 months ago
5.0 - 8.0 years
6 - 8 Lacs
Hyderabad, Madhapur
Work from Office
Key Tasks & Responsibilities: The IRT Project Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Project Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. Revises / develops the clinic...
Posted 4 months ago
8.0 - 12.0 years
12 - 20 Lacs
Noida
Remote
**Urgent Hiring for the Role of Clinical Systems Specialist Veeva CDMS for our Team** Job Title: Clinical Systems Specialist Veeva CDMS Experience: 8+ years Location: Remote 100% Work Timing: US EST time zone Job Description: - Job Title: Clinical Systems Specialist Veeva CDMS Overview: We are looking for a skilled Clinical Systems Specialist with strong, hands-on experience in Veeva CDMS (EDC) . This role focuses on testing and validation within the Veeva environment and supports various modules in the Veeva CDMS suite. While deep experience with eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms is not required, you should understand how they...
Posted 5 months ago
1.0 - 6.0 years
4 - 8 Lacs
Bengaluru
Work from Office
ECMS Req # 531129 Number of Openings 1 Duration of Hiring 1 year No of years experience 5+ years Detailed job description - Skill Set: Area of expertise: Veeva Vault Clinical CTMS & eTMF; Veeva Vault CDMS EDC Should have exposure and experience in Integrations, connections, configuration, Build, enhance, support experience. Functional knowledge of clinical trials and correlation with clinical systems is added advantage Should be able to demonstrate his technical and functional skills Hands on technical configuration experience Should have experience in configuring workflows and implement enhancements on their own Performed Veeva quarterly updates in the past Independent should lead the proje...
Posted 5 months ago
6.0 - 10.0 years
12 - 22 Lacs
Noida
Remote
Position: Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT) Overview: We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies. Job Description: Key Responsibilities: Author and execute test scripts in Veeva EDC, aligned with protocol requirements Validate workflows across eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms Particip...
Posted 5 months ago
2.0 - 6.0 years
4 - 9 Lacs
Navi Mumbai
Work from Office
Title Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based IRT Validator to join our Randomization and Study Product Management team in Mumbai, India. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global develop...
Posted 5 months ago
5.0 - 8.0 years
7 - 8 Lacs
hyderabad, madhapur
Work from Office
Key Tasks & Responsibilities: The IRT Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies As an expert in IRT, the Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations Revises / develops the clinical study protocol ...
Posted Date not available
10.0 - 20.0 years
25 - 40 Lacs
noida
Remote
Position: Data Quality System Testing Consultant Experience: 10+ Years Mode: Remote Time: US EST Hours Objective / Purpose: Create and execute detailed test plans and UAT scripts in Excel and /or ALM testing system based on business requirements and technical specifications to verify study/library functionality in Veeva CDMS and/or Rave EDC system and adherence to standards. Drive study database user acceptance testing activities and ensure the quality of the study build in the EDC system. Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices us...
Posted Date not available
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