- SAS Edit Check Programming: Create and program complex SAS edit checks according to specifications, testing them for functionality and identifying potential issues before implementation.
- Technical Leadership & Collaboration: Act as a technical point of contact for systems deliverables and provide programming support to Clinical Study Teams. You will work collaboratively with Clinical Data Management to meet study deliverables and timelines.
- Data & Systems Support: Support clinical trial platform technologies and provide technical and business process input on new and emerging technologies. You will also act as a data scientist, bringing awareness to patterns and analytical insights to support decision-making.
- Quality & Compliance: Develop, review, and implement policies, SOPs, and associated documents. You will assist in preparing for and responding to audit findings, both internal and external.
- Project Management: Contribute to large system transformation projects, with a focus on project management, stakeholder engagement, and change management.
- Proficient in SAS edit check programming.
- Operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).
- Strong understanding of Good Clinical Practice, drug development, and clinical trials processes.
- Knowledge of systems development lifecycle, data management processes, and programming of clinical trial databases.
- Expertise in performance management techniques, problem-solving, and analytical thinking.
- Experience with project planning and management.
- Experience with quality management, risk analysis, and process improvement methodologies.
- A Bachelor's degree or equivalent in life science, computer science, business administration, or a related field, or a Master's degree.
- Broad knowledge and experience in data management/programming in the Pharmaceutical or Biotech industry.
- General biopharmaceutical clinical research experience is preferred.
- Experience in oversight of outside vendors (CROs, central labs, etc.) is a plus.
- Leadership: A strong leader with a demonstrated ability to influence stakeholders and mentor others.
- Problem-Solving: Excellent analytical and problem-solving skills, with a focus on using data to drive decisions.
- Communication: Strong verbal and written communication skills, with the ability to collaborate effectively with global, cross-functional teams.
- Proactiveness: High degree of initiative and self-motivation, with the ability to manage multiple priorities successfully.
- Teamwork: Team-oriented, with a focus on achieving team goals.
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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 del ...
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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 ...
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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 ...
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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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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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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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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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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 ...
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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 ...
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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
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 create and implement edit checks, adhere to Amgen standards, and partner with cross-functional teams to ensure high-quality deliverables. You will also be a key contributor to large system transformation projects, leveraging your subject matter expertise and project management skills.
Roles & Responsibilities
Technical Skills & Knowledge
Qualifications
Soft Skills
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Manager, CSAR
Full time Amgen Technology Private Limited- Hyderabad / Secunderabad, Telangana
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The Manager, CSAR
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