Clinical Data Management, Senior Manager

Amgen • Thousand Oaks, CA

22h

About The Position

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions. 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. Clinical Data Management, Senior Manager. What you will do. Let’s do this. Let’s change the world. In this vital role you will manage Clinical Data Management (CDM) activities within and across projects within the biosimilars operational unit in partnership with a CRO in a fully outsourced business model. As well as lead CDM function and system integrations at Amgen and CROs/external partners to ensure timely study data delivery. You will be a part of the Biosimilars group. Biosimilars are an important development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients. Quality biosimilar development requires a new paradigm, integrating all the science and experience at Amgen developing biologics as well as our quality manufacturing while creatively and rapidly executing a streamlined and efficient data generation program to demonstrate similarity to the originator product. Management of biosimilars CDM activities and program(s), including system infrastructure and integration and maintenance of SharePoint site permissions and content. Input into group goals and objectives Implementing CDM strategies and assisting in implementation of wider biosimilar goals and strategies Assisting with development of, reviewing, implementing and enforcing biosimilars SOPs Ensuring delivery of quality clinical trial data, within agreed upon timelines Ensuring CDM processes/systems meet regulatory and business requirements Assist with CRO contracts and budgets.

Requirements

• Doctorate degree and 2 years of clinical data management experience OR Master’s degree and 4 years of clinical data management experience OR Bachelor’s degree and 6 years clinical data management experience OR Associate’s degree and 10 years of clinical data management experience OR High school diploma / GED and 12 years of clinical data management experience
• Directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Nice To Haves

• Master's degree or equivalent in life science, computer science, business administration or related discipline
• 10 years of work experience in data management in the Pharmaceutical or Biotech arena
• 3+ years of experience in a global organization
• Previous experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)

Responsibilities

• Manage Clinical Data Management (CDM) activities within and across projects within the biosimilars operational unit in partnership with a CRO in a fully outsourced business model.
• Lead CDM function and system integrations at Amgen and CROs/external partners to ensure timely study data delivery.
• Management of biosimilars CDM activities and program(s), including system infrastructure and integration and maintenance of SharePoint site permissions and content.
• Input into group goals and objectives
• Implementing CDM strategies and assisting in implementation of wider biosimilar goals and strategies
• Assisting with development of, reviewing, implementing and enforcing biosimilars SOPs
• Ensuring delivery of quality clinical trial data, within agreed upon timelines
• Ensuring CDM processes/systems meet regulatory and business requirements
• Assist with CRO contracts and budgets

Benefits

• A 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
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed