Senior Manager - Clinical Data Management

Company: Initial Therapeutics, Inc.
Location: Washington
Posted on: June 1, 2025

Job Description:

Join Amgen's Mission of Serving PatientsAt 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.Senior Manager - Clinical Data ManagementWhat you will doLet's do this. Let's change the world. In this vital role, you will partner with the cross-functional study team, as well as FSP, to ensure delivery of the Amgen TA portfolio. You will achieve results through detailed goal setting, accountability measures, effective partnership, performance management, collaboration with other groups, and a dedication to serving customers, both inside and outside of Global Study Operations (GSO). You will focus on timely quality delivery, as well as consistency across the Data Management (DM) components.Responsibilities

• Through cross-portfolio review, ensure delivery of all timelines and deliverables for the GSO-DM components.
• Plan and lead all aspects of GSO-DM activities for various TA products, projects, vendors, or services.
• Risk Management.
• Resource Management.
• Strategic Portfolio Management.
• Quality Management.
• Stakeholder Management.
• Responsible for staff recruitment, management, and development, as well as staff performance in line with Amgen's process.
• Provide mentorship to staff and lead by example.
• Act as an SME across projects to ensure best practices in all GSO-DM processes and to ensure consistency within and across programs.
• Identify process improvement opportunities and drive forward.
• Evaluate the resourcing levels in partnership with FSP to ensure appropriate distribution and accountability for delivery of the portfolio demands.
• Ensure GSO-DM processes are appropriately developed and are clearly communicated, with an eye toward continuous improvement of performance measures.
• Cultivate and maintain effective partnerships and knowledge transfers across Amgen.
• Stay abreast of industry developments in the Data Management field and apply to appropriate systems or processes.
• Define and contribute in the process and/or technical implementation of DM and the wider GSO Strategies.
• Lead and/or participate in cross-functional key projects and/or working groups.
• Develop, review and implement policies, SOPs, and associated documents affecting DM globally.
• Provide technical and business process input/expertise and leadership on process improvement activities, new and emerging technologies.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a senior manager with these qualifications.Basic Qualifications:
  • Doctorate degree and 2 years of clinical data experience OR
  • Masters degree and 4 years of clinical data experience OR
  • Bachelors degree and 6 years of clinical data experience OR
  • Associates degree and 10 years of clinical data experience OR
  • High school diploma/GED and 12 years of clinical data experience.Preferred Qualifications:
    • Masters degree or equivalent in life science, computer science, business administration, or related subject area.
    • 10+ years experience in data management in the Pharmaceutical or Biotech arena.
    • 3+ years 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 of usAs 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 for a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comIn 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 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.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.
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Keywords: Initial Therapeutics, Inc., Leesburg , Senior Manager - Clinical Data Management, Executive , Washington, Virginia