Clinical Systems & Analytical Reporting Manager
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Remote type: Flex Commuter / Hybrid
Locations: United Kingdom - Cambridge, United Kingdom - Uxbridge, United Kingdom - London
Time type: Full time
Posted on: Posted Yesterday
Job requisition id: R-202392
Career Category Clinical
Job Description HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
CLINICAL SYSTEMS & ANALYTICAL REPORTING (CSAR) MANAGER
LIVE
What you will do
Lead and co-ordinate the definition of study design and standards in clinical trial databases and systems
Manage clinical trial platform technologies and support decision-making by acting as a data scientist, bringing awareness to patterns and analytical insight
Manage and operational oversight of Global Development Operations (GDO) systems, platforms and tools (e.g., EDC, IRT, CTMS) to ensure compliance to regulatory bodies
Ensure quality and timely operational delivery of systems activities supporting study or product level delivery, e.g., data standards/Global Library management
Provide technical and business process input on new and emerging technologies/vendors for clinical trial execution
Develop, review and implement processes, policies, SOPs and associated documents affecting GDO
Promote the continuous improvement of CSAR and the wider development organization through information sharing, training, mentoring and education
Promote and be an advocate for GDO internally and externally
Be part of our team
You would be joining a global team dedicated to accelerate clinical programs using innovative technologies, processes, programming standards, and growth of systems and analytics capabilities.
WIN
What we expect of you
Degree educated
Knowledge in data management / programming in the Pharmaceutical or Biotech fields
Previous project management and planning experience
Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.)
Knowledge of Good Clinical Practices (GCP) and familiarity with regulatory requirements
Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
Proficient in organizational applications and tools (e.g., Spotfire, MS Office)
Excellent written and verbal communication
THRIVE
What you can expect of us
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
LOCATION:
Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
APPLY NOW
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
About Us Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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Remote type: Flex Commuter / Hybrid
Locations: United Kingdom - Cambridge, United Kingdom - Uxbridge, United Kingdom - London
Time type: Full time
Posted on: Posted Yesterday
Job requisition id: R-202392
Career Category Clinical
Job Description HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
CLINICAL SYSTEMS & ANALYTICAL REPORTING (CSAR) MANAGER
LIVE
What you will do
Lead and co-ordinate the definition of study design and standards in clinical trial databases and systems
Manage clinical trial platform technologies and support decision-making by acting as a data scientist, bringing awareness to patterns and analytical insight
Manage and operational oversight of Global Development Operations (GDO) systems, platforms and tools (e.g., EDC, IRT, CTMS) to ensure compliance to regulatory bodies
Ensure quality and timely operational delivery of systems activities supporting study or product level delivery, e.g., data standards/Global Library management
Provide technical and business process input on new and emerging technologies/vendors for clinical trial execution
Develop, review and implement processes, policies, SOPs and associated documents affecting GDO
Promote the continuous improvement of CSAR and the wider development organization through information sharing, training, mentoring and education
Promote and be an advocate for GDO internally and externally
Be part of our team
You would be joining a global team dedicated to accelerate clinical programs using innovative technologies, processes, programming standards, and growth of systems and analytics capabilities.
WIN
What we expect of you
Degree educated
Knowledge in data management / programming in the Pharmaceutical or Biotech fields
Previous project management and planning experience
Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.)
Knowledge of Good Clinical Practices (GCP) and familiarity with regulatory requirements
Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
Proficient in organizational applications and tools (e.g., Spotfire, MS Office)
Excellent written and verbal communication
THRIVE
What you can expect of us
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
LOCATION:
Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
APPLY NOW
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
About Us Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
#J-18808-Ljbffr
