Biomedical Data Stewardship Sr Manager - Thousand Oaks, CA
Biomedical Data Stewardship Sr Manager - Thousand Oaks, CA
Posted on :
27-06-2025
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1 Vacancy
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Monthly Salary
$ 171722 - 171722
Vacancy
1 Vacancy
Posted on :
27-06-2025
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Biomedical Data Stewardship Senior Manager
What you will do
Lets do this. Lets change the world. Amgen is seeking a dynamic and experienced Biomedical Data Stewardship Manager to drive the design implementation and governance of standardized data collection practices across our clinical programs. In this vital role you will build and manage case report form (CRF) libraries develop implementation standards and partner closely with cross-functional teams to ensure high-quality data collection that supports drug development success. You will also lead standards implementation for study teams through hypercare sessions monitor and review use of standards and facilitate governance processes.
Key Responsibilities
Lead the designation and definition of standard indication-level CRF libraries using global standards-based and study-specific content and document implementation rules and decisions for their use in coordination with assigned subject matter experts.
Lead the design and review clinical data quality edit checks aligned with CRF content.
Provide expert consultation and hypercare support to study teams in applying CRF library content and related tools.
Monitor adoption and consistency of CRF standards conducting audits and reviews to ensure alignment with evolving study and regulatory needs.
Manage governance processes for evaluating and implementing updates or exceptions to CRF standards including triage and adjudication of change requests.
Coordinate with global standards governance bodies to ensure harmonized updates and compliant implementation across programs.
Curate and manage standards content within a metadata repository (MDR) ensuring traceability reusability and consistency.
Lead initiatives to expand data standards implementation across Amgens Global Development functions and external collaborations where applicable.
Biomedical Data Stewardship Senior Manager
What you will do
Lets do this. Lets change the world. Amgen is seeking a dynamic and experienced Biomedical Data Stewardship Manager to drive the design implementation and governance of standardized data collection practices across our clinical programs. In this vital role you will build and manage case report form (CRF) libraries develop implementation standards and partner closely with cross-functional teams to ensure high-quality data collection that supports drug development success. You will also lead standards implementation for study teams through hypercare sessions monitor and review use of standards and facilitate governance processes.
Key Responsibilities
Lead the designation and definition of standard indication-level CRF libraries using global standards-based and study-specific content and document implementation rules and decisions for their use in coordination with assigned subject matter experts.
Lead the design and review clinical data quality edit checks aligned with CRF content.
Provide expert consultation and hypercare support to study teams in applying CRF library content and related tools.
Monitor adoption and consistency of CRF standards conducting audits and reviews to ensure alignment with evolving study and regulatory needs.
Manage governance processes for evaluating and implementing updates or exceptions to CRF standards including triage and adjudication of change requests.
Coordinate with global standards governance bodies to ensure harmonized updates and compliant implementation across programs.
Curate and manage standards content within a metadata repository (MDR) ensuring traceability reusability and consistency.
Lead initiatives to expand data standards implementation across Amgens Global Development functions and external collaborations where applicable.
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of clinical experience
Or
Masters degree and 4 years of clinical experience
Or
Bachelors degree and 6 years of clinical experience
Or
Associates degree and 10 years of clinical experience
Or
High school diploma / GED and 12 years of clinical experience
Preferred Qualifications:
Degree in a related field such as statistics biostatistics life sciences programming computer science or business administration.
5 years cumulative experience in data management biostatistics or clinical programming within the pharmaceutical or biotechnology industry.
3 years of experience in a global matrixed organization.
Proven experience with CRF design data standards governance and clinical metadata repository (MDR) tools.
Extensive Experience in data collection analysis and reporting within drug development and clinical trial processes as well as utilizing metadata repository systems to curate and maintain standards-related assets.
Strong skills in project planning stakeholder engagement process improvement leadership documentation development training and compliance.
Proven ability to collaborate effectively build relationships on global cross-functional teams.
Effective written and verbal communication facilitation and negotiation skills with all levels within the organization.
Demonstrated success in SOP development and regulatory-compliant documentation practices.
Proficient in the use of software and data applications relevant to drug development.
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:
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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Salary Range
154897.00 USD - 171722.00 USD
Required Experience:
Manager
Employment Type
Full Time
Key Skills
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