Local Trial Manager - Brazil
Local Trial Manager - Brazil
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Job Description
Career Category
ClinicalJob 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.
Live
What you will do
Lets do this. Lets change the this vital role you will be the primary point of contact to lead manage and co-ordinate the conduct of clinical trials from study start-up to close out (CSR/Archival) at a country level in conformity with ICH-GCP and other applicable local regulations. You will maintain the quality and scientific integrity of clinical trials and actively collaborate with cross functional internal and external partners to ensure timely delivery budget implementation of clinical trial results within the local country.
Key Activities:
- You will partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery
- Planning management and oversight of clinical study implementation in accordance with the global program strategy through leadership with engagement of the cross-functional Local Study Team
- Communicate country status (including timelines and results) to key partners including updates to relevant systems for transparency
- Provides 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 e.g. vendor management
- Assign and deliver all study support staff and continually review country level risk mitigation to ensure study delivers to plan
- You will build strong site relationships as well as other local relationships to ensure end to end study delivery is met.
Win
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The qualified professional we seek is a Local Trial Manager with the following qualifications.
Basic Qualifications:
Doctorate degree
OR
Masters degree & 2 years of Clinical Trials experience
OR
Bachelors degree & 4 years of Clinical Trials experience
OR
Associates degree & 8 years of Clinical Trials experience
Or
High school diploma / GED & 10 years of Clinical Trials experience
Preferred Qualifications:
- Educational Background in Life Science
- Work experience in life sciences or medical related field including biopharmaceutical clinical research experience acquired working on clinical trials in a biotech pharmaceutical or CRO company
- Minimum 2 years leading local/regional or global teams experience
- Minimum 2 years Clinical Trial Project Management experience
- Proficiency in Portuguese and business English
- Experience in management and oversight of external vendors (e.g. CROs central labs imaging vendors etc.)
- Must be a local/country expert with identifiable project management experience
Please upload your resume in English
Thrive
What you can expect of us
As we work to develop treatments that take care of others we also work to care for our teammates professional and personal growth and well-being.
In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
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 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.
.Required Experience:
Manager
Employment Type
Full-Time
