Study Start-up Manager

Location: California

Study Start-up Manager page is loaded## Study Start-up Manager remote type:
Remote locations:
United States - Remote time type:
Full time posted on:
Posted Todayjob requisition :
R-237510##
** 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.
** Study Start Up Hub – Study Start-up Manager
**** 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…