Sr Mgr Local Study Operations

Career Category

Clinical

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel likeyourepart of something biggeritsbecause you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980wevehelped pioneer the world of biotech in our fight against the worlds toughest diseases. With ourfocus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen teamyoullhelp 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 themyoullthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Local Study OperationsSenior Manager

What you will do

Letsdo the this role you will lead the skill development of Local Study Operations Managers ensuring effective trial implementation within the country and strong alignment with global strategies. You will oversee the delivery of the countrys study portfoliomanaging scope timelines and budgetsthrough the management of in close partnership with the Country- Hub GSSO Head you will help foster enhance and sustainan optimalclinical research environment that supports global R&Dobjectives. Additionally you will drive alignment and continuous improvement in LSOM execution by integrating best practices promoting digital innovation andfacilitatingrobust knowledge sharing across the team.

• Ensure the successful delivery of the study portfolio assigned to LSOMs.

• Oversee LSOMs fulfillment of responsibilities throughout the assigned country portfolio from feasibility through to study close-out.

• Monitor portfolio progress provide risk and quality oversight and support issue escalation and resolution for LSOMs.

• Manage LSOM and LSOM vendor performance to guarantee high-quality study execution serving as the primary escalation point for local study challenges driving solutions and ensuring portfolio targets are met within the country.

• Mentor train and support the professional development of LSOMs to prepare them for managing complex trials.

• Build andmaintaina high-performing team.

• Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio.

• Promote cross-functional collaboration among country teams to ensure successful delivery of the country portfolio.

• Support discussionsregardingstudy placement decisions based on country capabilities and growth potential.

• Proactively evaluate risks quality trends and resource requirements; implement mitigation strategies and drive continuous improvement in country operations.

• Lead initiatives to enhance operational efficiency and encourage sharing of best practices.

• Manage resource allocation and workload distribution across LSOMs including both FSP and FTE personnel tooptimizetrial execution and align with global priorities.

• Ensure adherence to regulatory and quality standards where applicable.

• Collaborate with and support thecountryhead in engaging cross-functional stakeholdersaligning ontrial deliverables and managing escalations.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. Thecandidateweseekisan individualwith the following qualifications.

Basic Qualifications:

• Doctorate degree & 2 years of clinical execution experience OR

• Masters degree & 6 years of clinical execution experience OR

• Bachelors degree & 8 years of clinical execution experience OR

• Associates degree & 10 years of clinical execution experience OR

• High school diploma / GED & 12 years of clinical execution experience

• In addition to meeting at least one of the above requirements you must have a minimum of 2years experiencedirectly managing people and/or leadership experience leading teams projects programs or directing the allocation managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• 7yearswork experience in life sciences or medically related field including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech pharmaceutical or CRO company

• Experience managing multiple teams / direct reports across multiple clinical functions / trials

• Experience at oroversight of clinical research vendors (CROs central labs imaging vendors etc.)

• Experience managing clinical operations across relevant geography / region including strong understanding of local regulatory requirements around global clinical trials

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 culturewellsupport your journey every step of the way.

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:

• 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 and bi-annual company-wide shutdowns

• Flexible work models including remote work arrangements where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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 accomplishedpeople who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against seriousdisease.

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 toparticipatein 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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Salary Range

EUR-EUR

Required Experience:

Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1