Associate Clinical Trial Leader
4 weeks ago
May lead studies in maintenance or in closeout phase or ongoing studies post primary database lock with the oversight of the LCTL/CTL, as assigned. Support the clinical protocol development process in collaboration with the CTL/Lead CTL and the Clinical program Leader (CPL): chip in to the development of clinical protocols, amendments and related documents; drive and/or supprt trial-related documents and processes.
development of clinical section of regulatory documents like Investigator’s Brochure, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
support the global multidisciplinary CTT to ensure all trial results are met according to timelines, budget, quality standards and operational procedures: attend CTT meetings, assist in report study progress and issues.
support the CTL/Lead CTL, in the ongoing review and cleaning of the clinical trial data, support final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings with investigators.
Responsible for accuracy of trial information in all trial databases and tracking systems. Attend relevant meetings to support ongoing execution of clinical trial and program level activities.
ensure that program specific standards/activities (e.g., CRFs, UAT testing, database specifications, Data Handling plan, outsourcing specifications including imaging, biomarkers, PK, data monitoring, validation plans and data transfer specifications) are applied to the clinical trial, where applicable.
develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; handle work with external vendors in collaboration with the CRO; Management Department as well as with the Assay Research Lab. This also includes the set-up, logistics, documentation and clinical supplies needed for the clinical trial(s).
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Clinical Research Associate
2 weeks ago
hyderabad, India Lifelancer Full timeJob Summary: We are seeking a highly motivated and experienced Clinical Research Associate (CRA) with a minimum of 2-3 years of relevant experience. The CRA will play a critical role in ensuring the successful planning, execution, and monitoring of clinical trials. The ideal candidate will have a strong understanding of clinical trial processes, regulatory...
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Clinical Research Associate
2 weeks ago
Hyderabad, India Learning Labb Research Institute Full timeAs a Clinical Research Associate, you'll play a pivotal role in ensuring the successful execution of clinical trials. From monitoring trial progress to ensuring regulatory compliance and participant safety, you'll be at the forefront of cutting-edge medical research.Key Responsibilities:- Conduct site visits to monitor trial activities and ensure compliance...
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Clinical Trial Payments Analyst II
13 hours ago
Hyderabad, India Bristol Myers Squibb Full timeWorking 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...
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Clinical Operations Coordinator
4 weeks ago
Banjara Hills, Hyderabad, Telangana, India WorldCare Clinical (WCC) Full timeAs part of a study team, participates in processing and quality assurance checks of clinical trial data to ensure data integrity and consistency. Has direct contact with the trial sponsors and internal and external team members. Performs established processing techniques across multiple imaging modalities using proprietary and third-party package software.
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Associate Clinical Data Manager
4 weeks ago
Hyderabad, India Statistics & Data Corporation (SDC) Full timeAssociate Clinical Data Manager SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great...
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Associate Clinical Data Manager
4 weeks ago
hyderabad, India Statistics & Data Corporation (SDC) Full timeAssociate Clinical Data Manager SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great...
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Senior Clinical Data Associate
4 weeks ago
Hyderabad, India Statistics & Data Corporation (SDC) Full timeSDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure...
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Document Coordinator, Global Trial Acceleration
4 weeks ago
Hyderabad, Telangana, India Bristol-Myers Squibb Full time**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...
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Document Coordinator, Global Trial Acceleration
14 hours ago
Hyderabad, India Bristol Myers Squibb Full timeWorking 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...
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Associate Medical Expert
1 week ago
Hyderabad, India Novartis Full time387199BR **Associate Medical Expert**: India **About the role** Associate Medical Expert Location - Hyderabad #LI Hybrid About the Role: The Associate Medical Expert will ensure the successful implementation and delivery of the Medical and Knowledge Solutions (MKS) scientific and medical services along the business colleagues’ requirements. He/ she is...
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Senior Transparency Associate
4 weeks ago
hyderabad, India Novartis India Full timePosition Title :Senior Transparency AssociateAbout the role :Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical...
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Senior Transparency Associate
4 weeks ago
Hyderabad, India Novartis India Full timePosition Title :Senior Transparency AssociateAbout the role :Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical...
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Senior Transparency Associate
4 weeks ago
Hyderabad, India Novartis India Full timePosition Title :Senior Transparency AssociateAbout the role :Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of clinical...
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Senior Transparency Associate
4 weeks ago
Hyderabad, India Novartis India Full timePosition Title : Senior Transparency Associate About the role : Be part of a growing Industry expertise! Come, join a global team of nearly 200 regulatory professionals- life scientists, clinicians and project managers across 6 countries and support Novartis operational expertise in the mobilization of the organization’s commitment to sharing of...
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Hyderabad, India Cytel Full timeAt Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.Senior Clinical Programmer/Senior Report programmer role to develop...
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Global Trial Manager
7 days ago
Hyderabad, India Bristol Myers Squibb Full timeDescription Global Trial Managers, crossing all therapeutic areas and research phases, collaborate with cross-functional teams to drive operational aspects of complex, global clinical research studies from concept to final clinical study report Position Summary / Objective • Leads successful and timely operational execution of global insourced or...
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Line Manager, Global Trial Management
7 days ago
Hyderabad, India Bristol Myers Squibb Full timeDescription Line Manager of Global Trial Specialists within Global Trial Management, crossing all therapeutic areas and research phases. Position Summary / Objective • Manages performance and career development of Global Trial Specialists (may include Associate Global Trial Managers). • Member of the Department Leadership Team focused on...
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Hyderabad, India Cytel Full timeAt Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development. Senior Clinical Programmer/Senior Report programmer role to develop...
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hyderabad, India Cytel Full timeAt Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development. Senior Clinical Programmer/Senior Report programmer role to develop...
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Global Trials Manager
4 weeks ago
hyderabad, India Michael Page Full timeOpportunity to work with a leading healthcare MNC Best in-class industry experience and benefits About Our Client A global biopharmaceutical company committed to discovering, developing and delivering innovative medicines to patients worldwide. Job Description * Directs and delegates to assigned Global Trial Management staff as...