Clinical Document Management
4 weeks ago
Summary Clinical Document Governance Management CDGM is accountable for strategy and delivery of clinical document management CDM systems processes standards and operations of CDM services including Trial Master File management TMF clinical submission readiness record retention and archiving Good Documentation Practice capability build across Novartis globally In addition CDGM is driving the transformation of TMF at Novartis through the introduction and adoption of new technologies processes and ways of working The CDM Business Migrations Manager is responsible for effective planning and delivery of migrations to and from of Novartis enterprise-wide clinical electronic document management systems eDMS aligned to Novartis business needs partnering with technical vendors internal IT and business stakeholders Drives implementation of CDGM initiatives projects and process improvement activities to enhance the planning and execution of migrations to and from enterprise clinical eDMS at Novartis Act as CDGM point of contact for partnering with CDGM IT internal and external and business stakeholders to plan and execute migrations to and from eDMS in line with Novartis business compliance and operational requirements Partner with CDGM and business stakeholders especially those planning in-licensing and out-licensing activities to identify and agree migration business requirements understand source and target system capabilities and develop maintain a future migration roadmap Contribute to activities to ensure efficient processes integrations of systems with eDMS based on strong understanding of Novartis enterprise systems landscape and in line with compliance and business priorities Serves as Subject Matter Expert for training materials formal and informal processes and tracking tools for eDMS migration activities in collaboration with CDM Process team and other key stakeholdersPlan and contribute to agile working methodologies being applied during development cycles to prepare for migration and during post migration hyper care period Owner or Contributor of activities related to migration related Incident Management Change Management and ongoing operations of the eDMS Support forecasting of internal resource allocations and vendor provided activities as part of eDMS migration roadmap management Executes vendor oversight plan monitors service metrics and identifies opportunities for improvement to the operating model in relation to migration Acts as point of escalation for issues Provides support for inspections audits contributes to root cause analysis identification and creation delivery of CAPAs Minimum Requirements Advanced degree or combination of Bachelors degree in information or life-sciences healthcare and relevant industry experience Minimum of 6 years working in Pharmaceuticals Lifesciences and Clinical Research with specific experience in contributing and leading of clinical document management TMF and or records information management Minimum of 5 years of full-scale migrationsMinimum 2 medium to major Veeva related hands-on and provable experience in leading and planning of migrations Prior experience in Electronic Document Management systems specifically in Clinical and Regulatory highly desired Business relevant technical and working experience of eDMS systems like Veeva Clinical vault RIM Documentum D2LS or similarKnowledge of industrywide Electronic and Clinical Document Management systems and featuresDeep knowledge of Agile way of working with cross functional teams for releasesStrong influencing and presentation skills Ability to communicate effectively at all levelsNovartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve Skills Desired Budget Management Clinical Trials Negotiation Process Improvements Project Planning Vendor Management Waterfall Model Novartis
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Clinical Document Management
3 weeks ago
Hyderabad, Telangana, India myGwork Full timeThis job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Summary Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and...
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Clinical Document Management
4 weeks ago
Hyderabad, Telangana, India Novartis India Full timeJob DescriptionSummaryClinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability...
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Clinical Document Coordinator
2 days ago
Hyderabad, Telangana, India Yashoda Hospital Full timeClinical Document Coordinator Job Summary">We are seeking a skilled Clinical Document Coordinator to join our medical documentation team at Yashoda Hospital. As a key member of our team, you will be responsible for ensuring the accuracy and efficiency of our clinical documentation processes.">Main Accountabilities:">">Type medical discharge summaries with...
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Clinical Trial Documentation Lead
17 hours ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob DescriptionAs a Clinical Trial Documentation Lead, you will be responsible for managing a team that reconciles and prepares clinical trial submission documents in accordance with regulatory guidelines. You will ensure consistency across all BMS programs by supervising a team of Clinical Trial Support Specialists and providing support to in-house and...
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Clinical Trial Documentation Manager
3 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeThis is a supervisory position overseeing a team of eTMF Specialists responsible for document upload and management in the electronic Trial Master File (eTMF) in support of Bristol Myers Squibb Clinical Trials across the enterprise.Key ResponsibilitiesManage the allocation of workload across a team of eTMF Specialists to ensure efficient document processing...
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Line Manager, Clinical Documentation
4 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeAbout the Job: We are seeking an experienced Line Manager to join our Global Trial Acceleration Center team. In this role, you will be responsible for managing and executing centralized activities in support of global trials with an emphasis on clinical documentation. The position requires a high level of adaptability in dealing with ambiguous and complex...
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Clinical Science Team Manager
9 hours ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeAbout the JobWe are seeking a Clinical Science Team Manager to join our ECD Clinical Science team. The successful candidate will manage and supervise a team of Clinical Scientists in ECD to execute trial level activities for multiple trials.Key AccountabilitiesLead the implementation of all study startup/conduct/close-out activities as applicable.Collaborate...
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Clinic manager
3 weeks ago
Hyderabad, Telangana, India Naukripay Full timeJob Description Mail :- info@naukripay.com clinic manager manages the day-to-day operations of a clinic. They oversee staff, ensure compliance with regulations, and coordinate patient care. Responsibilities Staff management: Recruit, train, and evaluate staff performance Patient care: Develop and implement care protocols, coordinate care plans, and...
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Clinic manager
3 weeks ago
Hyderabad, Telangana, India Naukripay Full timeMail :- clinic manager manages the day-to-day operations of a clinic. They oversee staff, ensure compliance with regulations, and coordinate patient care. Responsibilities Staff management: Recruit, train, and evaluate staff performance Patient care: Develop and implement care protocols, coordinate care plans, and counsel patients Compliance: Ensure...
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Clinical Development Manager
4 weeks ago
Hyderabad, Telangana, India Azurity Pharmaceuticals Full timeJob DescriptionAzurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its...
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Global Document Management Coordinator
4 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full time**Key Responsibilities:**The Document Coordinator will be responsible for:Managing and executing on centralized activities in support of global clinical trials, with an emphasis on clinical documentation.Developing and maintaining collaborative working relationships with relevant stakeholders, including CROs/vendors, Country Trial Managers (CTM)/Clinical...
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Clinical Development Manager
3 weeks ago
Hyderabad, Telangana, India Lifelancer Full timeJob Title: Clinical Development Manager Job Location: Hyderabad, Telangana, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader...
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Clinical Data Manager
3 weeks ago
Hyderabad, Telangana, India Imaging Endpoints Full timeSUMMARYImaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...
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Clinical Data Manager
3 weeks ago
Hyderabad, Telangana, India Imaging Endpoints Full timeSUMMARYImaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...
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Imaging Clinical Trial Manager
10 hours ago
Hyderabad, Telangana, India Imaging Endpoints Full timeJob SummaryThe Imaging Clinical Trial Manager is responsible for coordinating clinical trial activities, including site evaluations, training, and audit preparation. This role requires strong organizational and communication skills, as well as experience in the medical or clinical trials industry.Key Responsibilities:Evaluate sites for capability to...
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Clinical Trial Specialist
5 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeRole OverviewBristol Myers Squibb is an integrated global hub focused on helping patients overcome serious diseases by developing sustainable and innovative solutions. Our technology and drug development activities aim to usher in the next wave of innovation.The Clinical Trial Specialist role has task-level responsibility for document and CTA package...
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Clinical Data Manager
3 weeks ago
Hyderabad, Telangana, India Imaging Endpoints Full timeSUMMARYImaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...
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Global Document Coordinator
4 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob DescriptionWe are seeking a skilled Global Document Coordinator to join our team at Bristol Myers Squibb. In this role, you will be responsible for managing and executing centralized activities in support of global trials with an emphasis on clinical documentation.ResponsibilitiesManage and execute centralized activities in support of global trials with...
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeBMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation. Position...
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Clinical Content Specialist
2 hours ago
Hyderabad, Telangana, India Hetero Full timeWe are looking for a highly skilled Clinical Content Specialist to join our team at Hetero. As a Clinical Content Specialist, you will be responsible for developing and reviewing clinical documents, including protocols, investigator brochures, case record forms, product rationales, prescribing information, drug interactions, and clinical study reports.About...
