Clinical Study Data Delivery Manager

Study Data Delivery Manager

Career Category

Clinical

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.

Data Delivery Lead

What you will do

Let’s do this. Let’s change the world. In this vital role you are accountable for the management and oversight of data collected within a study/program, you will lead end-to-end data management and ensure high-quality, timely, and decision-ready data that enables successful clinical trial delivery.

• Serve as the single accountable leader for study-level data management, driving quality, delivery, and cross-functional alignment, locally and globally

• Lead development and execution of the Data Management Plan and Integrated Data Review Plan (IDRP) aligned to protocol and program strategy

• Drive database build, UAT, and go-live readiness in partnership with Database Design and Acquisition teams

• Oversee study conduct activities including data cleaning, query management, reconciliation, and database lock preparation, ensuring we are ‘delivery ready’ at all times

• Monitor study data metrics (e.g., eCRF entry, Non-CRF data collection, query aging, reconciliation backlog, KRIs) and proactively resolve issues to ensure on-time delivery

• Lead data deliverables, proactive in follow up, ensuring issue resolution and high-quality outputs

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.

Preferred Qualifications:

• 8-12 years’ work experience in life sciences or medically related field, including 5 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

• Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials

• Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)

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.

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. careers.amgen.com

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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Experience Level

Mid Level