Clinical Study Planning Manager - US Remote

Career Category

Job Description

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 Manager

Live

What you will do

Let’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

Win

What we expect of you

We 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

Thrive

What you can expect of us

As 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