Manager, CSAR – Custom function Programming
Amgen
Manager, CSAR – Custom function Programming
Job Description
Join Amgen’s Mission of Serving Patients
What you will do
- 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 complied 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)
What we expect of you
- Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline (Preferred)
- Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena (Preferred)
- General project management and planning experience (Preferred)
- Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) (Preferred)
- Bachelors degree or equivalent in life science, computer science, business administration or related discipline with 9 to 12 years of experience (Basic)
- Specialist knowledge / experience in life sciences or a medically related field (Basic)
- General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) (Basic)
Must-Have Skills
- 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
- Operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC)
Good-to-Have Skills
- Good Clinical Practice
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
30,000 - 50,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Good Clinical Practiceintermediate
- Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinkingintermediate
- Drug development and clinical trials processesintermediate
- Data management processesintermediate
- Clinical trial databases and applicationsintermediate
- Edit check development and Custom function programingintermediate
- Programming Languagesintermediate
- Systems development lifecycleintermediate
- Project planning and managementintermediate
- Collaborating with global cross-functional teams (team/matrix environment)intermediate
- Quality management and Risk Analysisintermediate
- Regulatory filings and inspectionsintermediate
- Process improvement methodologiesintermediate
- Operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC)intermediate
Required Qualifications
- Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline (Preferred) (experience)
- Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena (Preferred) (experience)
- General project management and planning experience (Preferred) (experience)
- Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) (Preferred) (experience)
- Bachelors degree or equivalent in life science, computer science, business administration or related discipline with 9 to 12 years of experience (Basic) (experience)
- Specialist knowledge / experience in life sciences or a medically related field (Basic) (experience)
- General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) (Basic) (experience)
Responsibilities
- 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 complied 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)
Tags & Categories
Manager, CSAR – Custom function Programming
Amgen
Manager, CSAR – Custom function Programming
Job Description
Join Amgen’s Mission of Serving Patients
What you will do
- 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 complied 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)
What we expect of you
- Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline (Preferred)
- Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena (Preferred)
- General project management and planning experience (Preferred)
- Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) (Preferred)
- Bachelors degree or equivalent in life science, computer science, business administration or related discipline with 9 to 12 years of experience (Basic)
- Specialist knowledge / experience in life sciences or a medically related field (Basic)
- General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) (Basic)
Must-Have Skills
- 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
- Operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC)
Good-to-Have Skills
- Good Clinical Practice
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
30,000 - 50,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Good Clinical Practiceintermediate
- Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinkingintermediate
- Drug development and clinical trials processesintermediate
- Data management processesintermediate
- Clinical trial databases and applicationsintermediate
- Edit check development and Custom function programingintermediate
- Programming Languagesintermediate
- Systems development lifecycleintermediate
- Project planning and managementintermediate
- Collaborating with global cross-functional teams (team/matrix environment)intermediate
- Quality management and Risk Analysisintermediate
- Regulatory filings and inspectionsintermediate
- Process improvement methodologiesintermediate
- Operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC)intermediate
Required Qualifications
- Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline (Preferred) (experience)
- Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena (Preferred) (experience)
- General project management and planning experience (Preferred) (experience)
- Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) (Preferred) (experience)
- Bachelors degree or equivalent in life science, computer science, business administration or related discipline with 9 to 12 years of experience (Basic) (experience)
- Specialist knowledge / experience in life sciences or a medically related field (Basic) (experience)
- General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company) (Basic) (experience)
Responsibilities
- 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 complied 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)
Tags & Categories