- Support of clinical trial platform technologies
- Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight.
- Coordinating and providing programming support to Clinical Study Teams
- Ensure efficient and consistent use of EDC system and ensure the use is aligned with the established procedures or standards.
- Acting as a technical point of contact for systems deliverables on defined programs
- Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment.
- Providing technical and business process input / expertise on new and emerging technologies
- Develop, review and implement policies, SOPs and associated documents
- Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes.
- Assist in preparing for and responding to audit findings (internal or external).
- Good Clinical Practice
- Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
- Drug development and clinical trials processes
- Data management processes
- Clinical trial databases and applications
- Edit check development and Custom function programing
- Programming Languages
- Systems development lifecycle
- Project planning and management
- Collaborating with global cross-functional teams (team/matrix environment)
- Quality management and Risk Analysis
- Regulatory filings and inspections
- Process improvement methodologies
- Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field
- Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena
- General project management and planning experience
- Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, IRT vendors, etc.)
- Bachelors degree or equivalent in life science, computer science, business administration or related field
- Specialist knowledge / experience in life sciences or a medically related field
- General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
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The Manager, CSAR - Electronic Data Interchange and Acquisition · What you will do · The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Intercha ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. · The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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Key Deliverables: · Author and manage DARS documents to define vendor data transfer specifications · Oversee integration, validation, and processing of clinical trial electronic data · Support large-scale clinical system transformation and change management initiatives · Ensure d ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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Responsibilities include, but are not limited to, the following: · Support of clinical trial platform technologies · Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. · Coordinating and providing programming support to Cl ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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Responsibilities include, but are not limited to, the following: · Support of clinical trial platform technologies · Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. · Coordinating and providing programming support to Cl ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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About The Role · The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Interchange/Acquisition programming activities. The Manager, CSAR - Electron ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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Manager, CSAR - Electronic Data Interchange and Acquisition · Role Description · The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical Reporting, focusing on Electronic Data Interchange/Acquisition programmi ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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Responsibilities include, but are not limited to, the following: · Support of clinical trial platform technologies · Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. · Coordinating and providing programming support to Cl ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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We are seeking a talented individual to join us as a Study Designer and Edit Check Programmer within the Clinical Systems and Analytical Reporting (CSAR) team. This role is a crucial blend of technical expertise and leadership, where you'll build and program studies in our clinic ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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The Manager, CSAR - SAS Edit Check Programmer will report to the Senior Manager, Clinical System and Analytical Reporting, and will be focused on supporting SAS Edit check programming activities. This role is a blend of leadership and individual contribution, requiring you to cre ...
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As the Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer, you will report to the Senior Manager of Clinical System and Analytical Reporting. This role is focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. You will be responsib ...
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As the Manager, CSAR - Global Library, you will report to the Senior Manager of Clinical System and Analytical Reporting and will focus on supporting Global Library activities. This role is a blend of leadership and individual contribution, where you will provide database design ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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Responsibilities include, but are not limited to, the following: · Support of clinical trial platform technologies · Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. · Coordinating and providing programming support to C ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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Support of clinical trial platform technologies · Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. · Coordinating and providing programming support to Clinical Study Teams · Works collaboratively with Clinical Data Manag ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
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Study Designer and Edit Check Programmer · We are looking for a talented individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting. · The successful candidate will play a crucial role in a ...
Hyderabad / Secunderabad, Telangana Full time1 day ago
Manager, CSAR - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited
Description
We are seeking a strong leader who can confidently influence collaborators and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).
Responsibilities include, but are not limited to, the following:
Knowledge
Preferred Qualifications
Basic Qualifications
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The Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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The Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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The Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
-
Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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Manager, CSAR – Custom Function Programming
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana