Study Liaison Manager
Study Liaison Manager
Posted on :
12-02-2025
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1 Vacancy
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Job Description
Job Title: Study Liaison Manager
Job Location: Hyderabad Telangana India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level:
Join Amgen’s Mission of Serving Patients
At Amgen if you feel like you’re part of something bigger it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980 we’ve helped pioneer the world of biotech in our fight against the world’s 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 you’ll 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 awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Study Liaison Manager
What You Will Do
Let’s do this. Let’s change the world. In this vital role you will Accountable for the development of Global Patient Safety (GPS) strategy for safetyrelated organized data collection in Amgen clinical trials in compliance with global regulatory requirements and Amgen compliance policies and standards.
Accountable for the review approval and execution of GPS safety data collection strategy across clinical programs (e.g. interventional observational research nonAmgen sponsored clinical research posttrial access expanded access etc.).
Responsible for participating in crossfunctional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical programs for all Amgen products.
Job Summary
The Manager works on projects and process that ensures the strategies of the department are driven into the safety related organized data collection activities in Amgen clinical activities to ensure Amgen remains aligned with global safety legislation and requirements
Provides input to Clinical teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies activities/programs that may generate reportable safety event information
Accountable as liaison between clinical trial and Global Patient Safety to ensure capture of all reportable safety event data generated by such programs and activities
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Key Activities
We are all different yet we all use our unique contributions to serve patients. The vital attribute professional we seek is a type of person with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of directly related experience
OR
Master’s degree and 4 years of directly related experience
OR
Bachelor’s degree and 6 years of directly related experience
OR
Associate’s degree and 8 years of directly related experience
Or
High school diploma / GED and 10 years of directly related experience AND
4 years of managerial experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources
Preferred Qualifications:
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. From our competitive benefits to our collaborative culture we’ll support your journey every step of the way.
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.
careers.amgen.com
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.
At Amgen if you feel like you’re part of something bigger it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980 we’ve helped pioneer the world of biotech in our fight against the world’s 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 you’ll 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 awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Study Liaison Manager
What You Will Do
Let’s do this. Let’s change the world. In this vital role you will Accountable for the development of Global Patient Safety (GPS) strategy for safetyrelated organized data collection in Amgen clinical trials in compliance with global regulatory requirements and Amgen compliance policies and standards.
Accountable for the review approval and execution of GPS safety data collection strategy across clinical programs (e.g. interventional observational research nonAmgen sponsored clinical research posttrial access expanded access etc.).
Responsible for participating in crossfunctional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across clinical programs for all Amgen products.
Job Summary
The Manager works on projects and process that ensures the strategies of the department are driven into the safety related organized data collection activities in Amgen clinical activities to ensure Amgen remains aligned with global safety legislation and requirements
Provides input to Clinical teams on the needs and timelines of safety related organized data collection to ensure these needs are met and incorporated into Amgen studies activities/programs that may generate reportable safety event information
Accountable as liaison between clinical trial and Global Patient Safety to ensure capture of all reportable safety event data generated by such programs and activities
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Key Activities
- Participates in the creation and dissemination of appropriate safety reporting language in clinical trial key documents such as study protocols contracts safety management plans and investigative site study guidance documents
- Supports the department by being a liaison between clinical trial and Global Patient Safety to ensure capture of all reportable safety event data generated by such programs
- Support activities to ensure GPS input to clinical study initiatives
- Accountable for vendor oversight of clinical reconciliation activities to ensure reporting of all reportable safety event data within team’s remit
- Actively participates in cross functional projects that develop and support strong crossfunctional relationships and communication
- Develops and communicates plans/objectives to others as needed
- Maintains knowledge of adverse event reporting process and safety system and contribute to the development improvement and standardization of new processes and methods
- Contributes to projects which involve the implementation of new processes and methods within and across Global Patient Safety
- Maintain functional area standard operating procedures and contribute to R&D Standards documents as applicable
- Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
- Provide input to GPS contracting groups globally
- Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
- Performs other duties related to the position as vital as defined in Standard Operating Procedures or as requested by their supervisor.
We are all different yet we all use our unique contributions to serve patients. The vital attribute professional we seek is a type of person with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of directly related experience
OR
Master’s degree and 4 years of directly related experience
OR
Bachelor’s degree and 6 years of directly related experience
OR
Associate’s degree and 8 years of directly related experience
Or
High school diploma / GED and 10 years of directly related experience AND
4 years of managerial experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources
Preferred Qualifications:
- Able to effectively represent ideas both verbally and in writing
- Sound knowledge of the global safety environment regulations and guidance
- Project and/or Process Management experience & knowledge
- Sound understanding of safety data capture representation and interpretation
- Sound knowledge of related regulatory/industry considerations compliance issues and/or scientific discovery
- Able to apply multidisciplinary knowledge and understanding to effectively collaborate and negotiate within function and crossfunctionally
- Able to organize plan and prioritize workload for the function
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. From our competitive benefits to our collaborative culture we’ll support your journey every step of the way.
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.
careers.amgen.com
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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Employment Type
Full Time
Key Skills
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