Clinical Data Manager (US-Remote)

Lensa; Washington (District of Columbia); Remote; USD 49,000 - 81,000; Full time

Job summary

Join Amgen’s mission as a Clinical Data Manager where you'll play a pivotal role in ensuring the quality and timeliness of clinical data. This is an opportunity to influence patient outcomes while working within a collaborative and dynamic team. Candidates should bring a relevant degree along with solid experience in the biotech or pharmaceutical industry.

Benefits

Comprehensive employee benefits package

Generous company contributions to retirement plans

Annual bonus program

Flexible work models including remote and hybrid arrangements

Award-winning time-off plans

Qualifications

• Doctorate or Master's with clinical experience required.
• Experience in Project and Planning Management in Pharmaceutical or Biotech industry preferred.
• Go-getter attitude and strong communication skills are essential.

Responsibilities

• Coordinate and oversee Data Management tasks and timelines.
• Ensure quality control checks for database delivery.
• Lead vendor relationships and electronic submission activities.

Skills

Project Management

Data Management

Vendor Oversight

Education

Doctorate Degree

Master's Degree in Life Science, Computer Science, Business Administration or related field

Bachelor's Degree with clinical experience

Job description

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Lensa is the leading career site for job seekers at every stage of their career. Our client, Amgen, is seeking professionals. Apply via Lensa today!

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.

Clinical Data Manager

What You Will Do

Let’s do this. Let’s change the world. In this vital role you will be the Project Lead within Global Study Operations Data Management (GSO DM) and report to the Senior Manager-GSO Data Management. Amgen GSO-DM is strategically resourced with external vendor support through a functional service provider (FSP) model. The Data Manager taking this role will partner with cross functional study teams as well as the FSP to ensure product delivery of the Amgen Therapeutic Area portfolio.

Global Study Operations (GSO) – Data Management plans and implements the capture, cleaning and storage of all Amgen clinical study and trial management data.

Specific Responsibilities Include But Are Not Limited To

• Project level coordination of and day to day oversight of DM tasks including: Review all DM documents within a project area to ensure a consistent approach and review of project timelines and metrics to ensure databases are delivered to set timelines, and approve database locks and unlocks.
• Ensure that quality control checks are occurring such that quality databases are delivered.
• Develop and coordinate project level training for data management staff.
• Review and approve study specific training and lead vendor results and relationship at the project level.
• Communication of project level issues including processes, timelines, resourcing, performance, etc.
• Review of all study level non-DM documents for awareness and project level consistency.
• Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study / vendor level.
• Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting DM.
  
  

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The highly competent professional we seek is a go-getter with these qualifications:

Basic Qualifications

Doctorate Degree

Or

Master's Degree and 2 years of clinical experience

Or

Bachelor's Degree and 4 years of clinical experience

Or

Associate's degree and 8 years of clinical experience

Or

High school diploma/GED and 10 years of clinical experience

Preferred Qualifications

• Degree in life science, computer science, business administration or related field.
• Clinical Data, Project and Planning Management experience in the Pharmaceutical or Biotech industry.
• Experience in oversight of outside vendors (CRO’s, 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, we’ll 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, including remote and hybrid work arrangements, where possible
  
  

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

careers.amgen.com

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.

Application deadline

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.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  IT Services and IT Consulting

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