Local Trial Manager

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. 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.

Local Trial Manager

What you will do and what we expect of you

Lets do this. Lets change the world. In this vital role you will :

Duties : Process clinical data, including receipt, entry, verification, or filing of information; Monitor work productivity or quality to ensure compliance with standard operating procedures; Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation; Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices; Provide support and information to functional areas such as marketing, clinical monitoring, and medical affairs; Partner with global and local country teams to provide high level country strategy and actively drive study progress and local / country level study delivery; Plan, manage and oversee the clinical study implementation in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team; Communication country status (including timelines and results) to key partners including updated to relevant systems for transparency; Provide country level input into the Country Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study; Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate; and Assign and deliver all study support staff and continually review country level risk mitigation to ensure study delivers to plan. May telecommute.

Requirements : Masters degree (or foreign equivalent) in Drug Regulatory Affairs, Biology, Chemistry or related field & 3 years of experience in the following :

1. Management and oversight of external vendors, including CROs, central labs, and imaging vendors;

2. Knowledge of Good Clinical Practices (GCPs), FDA regulations, quality assurance and pharmaceutical industry;

3. Clinical trial processes and operations;

4. Knowledge of ICH / GCP regulations and guidelines;

5. Global to Local project management with oversight of study deliverables;

6. Project and program management including oversight of study deliverable, budgets and timelines;

7. Time, cost, and quality metrics, Key performance Indicators (KPIs);

8. Clinical Trial Management Systems like Medidata or Veeva, and Interactive Response Technology;

9. Data management skills and experience with data review, query resolution, data cleaning and database lock activities; and

10. Vendor management and oversight skills to manage, oversee and monitor applicable vendor activities including central laboratories, clinical research organization, and Interactive Response Technology.

Contact : Interested candidates please apply via https : / / careers.amgen.com / en / search-jobs and search for job # R-223001.

Job type : Full Time position. The annual salary range for this position in the U.S. is $ 126,432.00 - $144,987.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https : / / careers.amgen.com / life-at-amgen / benefits /

What you can expect of 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, 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.

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.