Manager, CSAR

4 weeks ago

Hyderabad, Telangana, India Amgen Technology Private Limited Full time
Job Description

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 services to clinical study teams, maintain standard libraries, and ensure adherence to Data Element Standards (DES). The ideal candidate will be a strong leader with proven ability to influence stakeholders, and will contribute to large system transformation projects while ensuring high-quality deliverables.

Roles & Responsibilities

- Global Library Management: You will provide Global Library review at the study level, coordinating closely with the Lead Data Manager. You will maintain standard libraries and provide database design services to clinical study teams in alignment with company standards. This includes creating and maintaining standard CRFs and Edit Checks in CDMS (RAVE) or other related technology.
- Technical Leadership & Collaboration: You will act as a technical point of contact for systems deliverables and provide programming support to Clinical Study Teams. You will offer technical and business process input on new and emerging technologies, and act as a data scientist to bring awareness to patterns and analytical insights.
- Process & Quality Assurance: You will lead or coordinate the definition of studies in clinical trial databases and systems. You will also maintain standard business processes within Global Development Operations (GDO) to ensure compliance with regulatory bodies. This includes developing, reviewing, and implementing policies, SOPs, and associated documents, as well as assisting in preparing for and responding to audit findings.
- Project Management: You will help deliver large system transformation projects, with a focus on project management, partner engagement, and organizational change.

Technical Skills & Knowledge

- Operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).
- Strong understanding and experience with Good Clinical Practice, drug development, and clinical trials processes.
- Knowledge of CDISC and SDTM.
- Experience in programming of clinical trial databases and applications.
- Understanding of the systems development lifecycle, project planning, and management.
- Broad knowledge or work experience in data management/programming in the Pharmaceutical or Biotech arena.
- Experience in oversight of outside vendors (CROs, central labs, etc.) is a plus.

Qualifications

- A Master's degree, Bachelor's degree, or Diploma in life science, computer science, business administration, or a related field.
- An advanced degree is a plus.

Soft Skills

- Leadership: A strong leader with a proven ability to influence partners and effectively manage teams.
- Problem-Solving: Strong understanding and experience in using performance management techniques and analytical thinking.
- Communication: Excellent verbal and written communication skills, with a focus on collaborating 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.

  • The Manager, Csar

    3 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Career Category ResearchJoin Amgens Mission of Serving PatientsAt Amgen if you feel like youre part of something bigger its because you are Our shared missionxe2x80x94to serve patients living with serious illnessesxe2x80x94drives all that we do Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases With our...

  • Manager, Csar

    3 weeks ago

    Hyderabad, Telangana, India Amgen Full time

    Career Category ResearchJoin Amgens Mission of Serving PatientsAt Amgen if you feel like youre part of something bigger its because you are Our shared missionxe2x80x94to serve patients living with serious illnessesxe2x80x94drives all that we do Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases With our...

  • Manager, CSAR

    4 weeks ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time

    Job DescriptionWe 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 clinical trial database while ensuring compliance with Amgen's...

  • Manager, CSAR

    12 hours ago

    Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionResponsibilities 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 Clinical Study Teams- Ensure efficient and consistent use of EDC...

  • 15h Left Manager, CSAR

    4 weeks ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time

    Job DescriptionThe 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...

  • CSAR Manager

    1 day ago

    Hyderabad, Telangana, India Amgen Inc Full time

    Job Description- 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 Management to meet study deliverables and timelines- Acting as a...

  • The Manager, CSAR

    12 hours ago

    Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionResponsibilities 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 Clinical Study Teams- Works collaboratively with Clinical Data...

  • Manager, CSAR

    4 weeks ago

    Hyderabad, Telangana, India Amgen Technology Private Limited Full time

    Job DescriptionAs 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 responsible for creating patient data reports and dashboards, adhering to...

  • 15h Left) Manager, CSAR

    1 day ago

    Hyderabad, Telangana, India Amgen Inc Full time

    Job DescriptionResponsibilities 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 Clinical Study Teams- Works collaboratively with Clinical Data...

  • Strategic Project Delivery Specialist

    1 day ago

    Hyderabad, Telangana, India beBeeProjectManagement Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Job OverviewWe are seeking a seasoned project management professional to assume the role of 3 Days Left Manager, CSAR. As a key member of our organization, you will be responsible for overseeing the successful completion of projects within the designated timeframe.Key ResponsibilitiesLead cross-functional teams to deliver projects on time and to the desired...