Local Trial 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. 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 this vital role you will:

Duties: Communicate country status including timelines and deliverables to key partners including updates to relevant systems for transparency; Accountable for site-level goal setting and study specific deliverables for clinical sites within their countries; Manage oversee and supervise applicable vendor activities such as laboratories and equipment provisioning; Contribute and develop program and study-specific materials such as monitoring plan study specific training documents; Support and contribute to Clinical Study Teams or Trial Management Teams; Partner with global and local country teams to provide high level country strategy and actively drive study progress and local and country level study delivery; Provide planning management and oversight of clinical study execution in accordance with the global program strategy through leadership with engagement of the cross-functional Local Study Team; and Utilize local and country regulatory knowledge to contribute to non-Amgen medicine product provisioning and import and export license processes. May telecommute.

Requirements: Masters degree (or foreign equivalent) in Nursing or related field and 2 years of experience involving the following:

1. Site selection and accountable for site-level goal setting and study-specific deliverables for clinical sites within their country;

2. Monitoring the execution of the clinical study against timelines deliverables and budget;

3. Providing input into and leading the development of study-specific plans including case report forms data management plans monitoring plans and other documents;

4. Overseeing the quality and scientific integrity of clinical operations for studies;

5. Communicating study status including timelines and deliverables to key stakeholders such as clinical study team program managers therapeutic area heads or global development leads and overseeing updates to relevant systems;

6. Overseeing timely electronic case report form (eCRF) completion query resolution site-close out activities and activities of other contributing functional areas including data management biostatistician or safety; and

7. Leading managing and coordinating the conduct of clinical trials from study start-up to study close out at a country level in accordance with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and other applicable local regulations.

Contact: Interested candidates please apply via and search for job # R-223002.

Job type: Full Time position. The annual salary for this position in the U.S. is $157435.00 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 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.

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.