154 Etmf Jobs - Page 2

About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Specialist Qualifications: BE Years of Experience: 7 to 11 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the pat...

About The Role Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life en...

About The Role Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabl...

About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision...

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Analyst Qualifications: Any Graduation Years of Experience: 3-5 Yrs What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the pa...

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: Any Graduation,BE,MCA Years of Experience: 5-8 Yrs What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging aro...

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around ...

As an Integration Architect (ISG) at the company, you will play a crucial role in designing and implementing integration solutions for clinical operations. Your primary focus will be on Vault CTMS eTMF Medidata Rave and Rave Integration to ensure seamless data flow and system interoperability. **Responsibilities:** - Design and implement integration solutions for clinical operations to guarantee smooth data flow. - Collaborate with cross-functional teams to gather requirements and develop integration strategies. - Develop and maintain integration architecture using Vault CTMS eTMF and Medidata Rave. - Ensure system interoperability and data integrity across clinical operations platforms. - P...

As a Sr. Product Integrator (ISG) in our organization, your role will involve integrating and managing product solutions, with a specific focus on RAVE and Veeva Vault for eTMF. Your responsibilities will play a crucial part in ensuring seamless operations and compliance within the company. Key Responsibilities: - Lead the integration of RAVE and Veeva Vault for eTMF to streamline document management processes. - Oversee the configuration and deployment of eTMF systems to ensure compliance with industry standards. - Provide technical expertise in managing and troubleshooting RAVE and Veeva Vault applications. - Collaborate with cross-functional teams to align product integration with busines...

Accountabilities For This Role Include Accountable for study start-up and the maintenance of regulatory and ethics committee (EC) submissions, overseeing the collection, preparation, review, and tracking of documents required for the application process. Where applicable, responsible for submitting the appropriate applications and documentation to Regulatory Authorities and/or IEC/IRB during the start-up period, liaising with regulatory bodies and ethics committees and ensuring expertise in the regulatory field. Actively participate in Local Study Team (LST) meetings. In some countries, these activities may be performed by the regulatory department. Ensure timely updating of Clinical Trial M...

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Analyst Qualifications: BE/BTech/BSc Years of Experience: 3 to 5 years Language - Ability: English(Domestic) - Intermediate What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabl...

About The Role Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical data SVS Analyst Qualifications: Any Graduation,BE,MCA Years of Experience: 3-5 Yrs What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around...

You are an experienced Veeva Configuration Specialist sought for a position in Chennai by Themesoft. Ideal candidates should possess Veeva certification. The role involves working with Veeva Vault Configurations, VQL, and related tasks in the life sciences sector. **Key Responsibilities:** - Acquire 5-12 years of experience in the life sciences sector with a focus on Veeva Vault Configurations for any Vault. - Execute implementation, support, and administration of Veeva Vault platform for various suites like CTMS, QMS, Safety, eTMF, etc. - Define and implement global business processes for safety. - Possess a thorough understanding of international regulations and associated business process...

Role & responsibilities The role we do require is the clinical operational process/system & data expert . To be specific, the person should: - Understand key decision points within those processes - Have hands-on exposure to clinical operational technologies (CTMS, EDC, Clinical Project&Portfolio Mgmt systems, IRT etc, related workflows) - Be comfortable identifying Data Entities, Entity Attributes, and CDEs across processes - Bring strong data catalog management experience and familiarity with semantic web and ontologies to ensure knowledge is findable, reusable, interoperable, and scalable into work instructions This profile will enable the service we need: partner with business teams to a...

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertica...

Skill required: Clinical Data Services - Clinical eTMF Management Designation: Clinical Data Svs Associate Qualifications: BTech/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by conv...

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: BTech/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by conv...

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by convergin...

Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices and International Council for Harmonization guidelines (E6(R2)) Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review. Experience managing clinical content in a records management system or electronic Trial Master File system. Have strong communication skills, verbal and written. Experience Requirements: At least 3-5 year...

Roles and Responsibility Collaborate with cross-functional teams to develop and implement clinical trial protocols. Provide medical expertise and guidance on clinical research studies, including protocol development and review. Conduct site feasibility assessments and coordinate with investigators to ensure successful study execution. Develop and maintain relationships with key stakeholders, including sponsors, investigators, and regulatory agencies. Stay updated with changing regulations and guidelines governing clinical research, ensuring compliance and adherence to best practices. Participate in quality assurance activities to ensure high-quality deliverables. Job Requirements Strong unde...

What Youll Do - You will design & implement various innovative solutions in the realms of clinical trial, data management, analytics You will work in designing common data model based on clinical standards like SDTM / ADAM/ I ISS/ ISE . You will work on designing safety data mart for cross study analysis and exploratory analysis You will work on building analysis ready datasets which serves various safety and exploratory use cases across clinical trials. You have experience of building usecases like safety signal detection, reverse translation research, combination therapy exploration As a solution lead, your role will involve planning, offering tech consultancy, conducting assessments,and e...

Manage and oversee the development and implementation of clinical data management systems. Ensure compliance with regulatory requirements and industry standards for clinical data management. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain data quality control processes to ensure accuracy and integrity of clinical data. Provide training and support to staff on clinical data management systems and procedures. Analyze and resolve complex technical issues related to clinical data management. Job Requirements Strong knowledge of clinical data management principles and practices. Experience with Veeva EDC is highly desirable. Excellent ...

Conduct thorough reviews of clinical trial data to ensure accuracy, completeness, and compliance with regulatory requirements. Collaborate with cross-functional teams to identify and resolve data discrepancies and issues. Develop and maintain detailed reports of findings and recommendations for data improvements. Participate in developing and implementing process improvements to enhance data quality and efficiency. Provide training and support to junior staff members on data review procedures and best practices. Stay up-to-date with changing regulations and guidelines related to clinical data management. Job Requirements Strong understanding of Good Clinical Practice (GCP) principles and reg...

Assess database design requirements relevant to data capture tool, data extraction, processing and reporting. Design database based on protocol and clinical data manager specifications. Make recommendations to management concerning complex technical issues and provide solutions. Configuration and validation of mapping for datasets export from EDC. Program edit checks according to the specifications defined by the clinical data manager. Provide support in the fixing of any issues or required changes to eCRF and Edit Checks encountered during system testing, User Acceptance Testing (UAT) and deployment testing. Import external data in the EDC based on the Data transfer agreement developed in c...

About The Role Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Associate Manager Qualifications: BE/BTech/BSc Years of Experience: 10 to 14 years Language - Ability: English(Domestic) - Intermediate What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision...