Study Start-up Manager

Amgen; Deutschland; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Retirement and Savings Plan

Medical, Dental and Vision Coverage

Flexible work models

Zusammenfassung

Amgen is seeking a Study Start-Up Manager to drive planning and execution of clinical study start-up activities across global and local sites. You will ensure trials launch efficiently, compliantly, and with high quality, coordinating cross-functional teams and managing timelines, budgets, and regulatory requirements.

The role requires pharma expertise, strong leadership, and experience in global clinical operations.

Qualifikationen

• Requires pharma and clinical trial processes and operations expertise.
• Experience leading and managing global teams and projects.
• No prior Veeva experience required.

Aufgaben

• Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met.
• Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track.
• Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration.
• Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start.
• Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed.
• Apply strong regulatory knowledge (ICH-GCP) to enable high-quality execution.
• Manage internal resources and external suppliers to ensure compliant delivery of start-up activities.
• Contribute to continuous improvement by sharing expertise and mentoring colleagues.

Kenntnisse

Pharma operations

People leadership

Global project management

ICH-GCP knowledge

Cross-functional collaboration

Ausbildung

Doctorate in science/Pharmacology

Master's degree in life sciences

Bachelor's degree

Associate's degree

High school diploma

Tools

Veeva (no prior experience required)

Jobbeschreibung

Career Category

Clinical

Job Description

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Study Start Up Hub – Study Start-up Mgr

What you will do

Let’s do this. Let’s change the world. In this vital role you will drive the planning and execution of clinical study start-up activities, ensuring trials are launched efficiently, compliantly, and to the highest quality standards.

• Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met.

• Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track.

• Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration.

• Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start.

• Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed.

• Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution.

• Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities.

• Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications.

Basic Qualifications:

• Pharma Expertise: Requires pharma and clinical trial processes and operations expertise; no relevant therapeutic knowledge required

• Management Experience: Requires experience leading and managing global teams and project management experience

• Tech Skills: No prior Veeva experience required

• Doctorate degree OR

• Master’s degree and 3 years of clinical execution experience OR

• Bachelor’s degree and 5 years of clinical execution experience OR

• Associate’s degree and 10 years of clinical execution experience OR

• High school diploma / GED and 12 years of clinical execution experience

• In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 5 years work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

• Experience working in global clinical trial teams across multiple geographies

• Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management

• PMP Certification

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, we’ll support your journey every step of the way.

The annual base salary range for this opportunity in the U.S. is [Talent Acquisition to input market pay range].

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:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

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

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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