Clinical Systems & Analytical Reporting, Senior Manager

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Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Clinical Systems & Analytical Reporting, Senior ManagerWhat you will do

Lets do this. Lets change the world. In this vital role you will be responsible for implementation of technical projects and management of day-to-day platform oversight and serve as the technical expert for one or more technologies. The successful candidate will have a strong technical background in clinical trial applications (e.g., eTMF, CTMS, EDC, site facing technologies) and be a leader with demonstrated ability to influence stakeholders, to engage cross-departmentally, and to partner with the application vendor(s) to ensure delivery of services. The candidate should be technologist with a desire to learn and adapt to a changing technology ecosystem.

Responsibilities include, but are not limited to, the following:

• Drive innovation in the clinical trial technologies domain and be a change champion.
• Lead technical, data-related, and automation initiatives.
• Gather cross-functional input and drive implementation of technical solutions to meet regulatory and/or business requirements.
• Provide oversight and implement configurations (including roles, permissions, and functionality settings).
• Optimize the usage of the application (such as external tools, reports, and data repositories).
• Advise on data integrations with 3rd party/internal applications and data lake implementation by providing expertise on data design and review of API and web-service calls.
• Advise on validation scenario testing for configuration changes, defect fixes, and software enhancements.
• Support vendor oversight.
• Escalate technical issues that support critical business processes; Facilitate rapid issue resolution by working with the vendor and internally to resolve issues; provide technical troubleshooting expertise and impact evaluation; keep stakeholders informed of progress.
• Oversee communication with end users regarding systems maintenance activities and change management activities.
• Build effective relationships and partnerships within Study Start-up, Site Management, Programming, Analytics & Solutions Department, Global Development Operations (GDO), Global Statistical Programming, Global Safety, IS, Quality and Compliance.
• Provide study-level support when required.
• Support development/maintenance of SOPs, processes, templates and best practices.
• Assist in preparing for and responding to audit findings (internal or external).
• Provide training and mentorship to team members.
• Supervise staff (if applicable) through coaching, development, and guidance.
• Delegate tasks to assigned staff, FSP, or contractors that support larger deliverables and projects.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications.

Basic Qualifications:

Doctorate Degree and 2 years of clinical experience

Or

Master's Degree and 4 years of clinical experience

Or

Bachelor's Degree and 6 years of Clinical experience

Or

Associates degree and 10 years of clinical experience

Or

High school diploma/GED & 12 years of clinical experience

Preferred Qualifications:

• BA, BS, MS degree in the life sciences, computer science, business administration or related discipline
• Strong understanding of the concepts of clinical research and drug development
• 10 years of experience in technology within the life sciences at a software, biotech, pharmaceutical or CRO company
• Hands-on experience implementing and/or maintaining clinical trial applications (e.g., eTMF, CTMS, EDC, site facing technologies) along with integration design practices
• Knowledge of application configuration settings and permissions
• Experience leading technical projects
• Must be able to work in a global team-based matrix environment (multi time zones)

Skills:

• Strong project management skills with commitment to timeline management.
• Strong problem solving and decision-making abilities.
• Negotiation skills to influence decision-making.

Supplemental Experience:

• Broad knowledge of clinical trial areas including study startup, site oversight, study design, data collection, data management, monitoring, report development, and programming.
• Knowledge of decentralized clinical trials and emerging automation technology in the pharmaceutical/biotechnology industry
• Experience in oversight of outside vendors
• Experience with a programming language or software development.
• Experience with data sharing mechanisms (e.g., API, webservices)
• Experience with visual and analytical reporting to support trial performance and data activities
• Experience with validation documentation and best practices
• Experience authoring work instructions and guidance documents.
• Experience with internal and external inspections
• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided 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 accommodation.

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