Study Start-up Manager

Career Category

Clinical

Job Description

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.

Study Start Up Hub Study Start-up Mgr

What you will do

Lets do this. Lets change the 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

• Masters degree and 3 years of clinical execution experience OR

• Bachelors degree and 5 years of clinical execution experience OR

• Associates 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 well 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

Apply now

for a career that defies imagination

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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Required Experience:

Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1