Clinical Data Management, Senior Manager

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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

Lets do this. Lets change the 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

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The Data Management professional we seek is an analytical leader with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of clinical data management experience OR
• Masters degree and 4 years of clinical data management experience OR
  Bachelors degree and 6 years clinical data management experience OR
• Associates 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

Preferred Qualifications:

• Masters 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 (CROs central labs imaging vendors etc.)

What you can expect from 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 well support your journey every step of the way.

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.

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:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen 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.

Sponsorship

Sponsorship for this role is not guaranteed.

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. 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.

Salary Range