Clinical Study Planning Manager

28 Jul 2024

Vacancy expired!

HOW MIGHT YOU DEFY IMAGINATION?You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Clinical Study Planning ManagerLiveWhat you will doLet’s do this. Let’s change the world. In this vital role you will be responsible for driving cross functional planning and effective execution of studies through the development of realistic study timelines and objective communication of project status to improve global therapeutic value.Key Responsibilities-

Own the development of and supervise the implementation of high-quality, realistic, cross-functional, global clinical trial timelines, from design through final study reporting, in Amgen’s planning systems within specified deadlines

Lead, implement and communicate changes per the Change Impact Assessment Review & Approval (CIARA) process or other mechanisms as appropriate

Ensure alignment of funding/investment of clinical studies within assigned programs to support operational planning by functions (i.e., via monthly RAP, annual LRP, quarterly LE, etc.)

Maintain accuracy of clinical study timeline information in Amgen data control systems (e.g., Planisware PPM), through conducting integrity checks and data issue resolution on a routine basis for assigned study timelines

Partner with Resource Forecasting Group staff to support optimized planning of resources and budget.

Communicate information on clinical trial status, changes, and issues to team members, and confirm acceptance of clinical study timelines with functional representatives ensuring alignment with key operational goals and timelines

Increase the efficiency of trial operations through the sharing of cross-program knowledge and identification of standard leading to standardization across the organization

Build scenario options in support of decision-making for operational or strategic direction

Participate in (or lead) process improvement initiatives as assigned

WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:Basic Qualifications:

Doctorate degree OR

Master’s degree and 2 years of work experience in life science OR

Bachelor’s degree and 4 years of work experience in life science OR

Associate’s degree and 8 years of work experience in life science OR

High school diploma / GED and 10 years of work experience in life science

Preferred Qualifications:

Broad work experience in life sciences or medically related filed, including general biopharmaceutical clinical product development (clinical research or clinical operations experience acquired at a biotech, [pharmaceutical or CRO company)

Drug development knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations, and Regulatory

Project management tools and processes (e.g., MS Project, Planisware, PowerPoint)

Strong digital literacy, including word processing, presentation, and spreadsheet applications

ThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.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.Amgen offers a Total Rewards Plan comprising 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 including:

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 imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comApplication deadlineAmgen 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.Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.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.

Full-time