Job Title: Study Liaison Senior Associate
Location: Hyderabad, India
Work Location Type: On-site
Date Posted: February 4, 2025
Category: Safety
Job Summary:
As a Study Liaison Senior Associate at Amgen, you will be responsible for the development of the GPS strategy for safety-related organized data collection in clinical trials. This role ensures that clinical programs comply with global regulatory requirements and Amgen's compliance policies. You will collaborate with cross-functional teams to ensure the execution of safety data collection strategies and operational consistency across clinical programs for Amgen products.
Key Responsibilities:
Safety Data Collection Strategy:
Develop and execute the GPS safety data collection strategy across clinical programs, including interventional, observational research, and non-Amgen sponsored clinical research.
Ensure compliance with pharmacovigilance data collection standards in clinical trials.
Cross-functional Coordination:
Collaborate with project teams and managers to ensure seamless coordination and adherence to timelines.
Provide technical support to ensure the execution of the group's objectives.
Protocol and Contract Development:
Contribute to the development of protocols, contracts, safety management plans, and investigative site study guidance documents.
Clinical Reconciliation & Vendor Oversight:
Support clinical reconciliation activities and vendor oversight to ensure that all reportable safety event data is accurately captured and reported.
Administrative Support:
Perform administrative tasks related to project activities, including keeping schedules up to date and managing project folders.
What We Expect from You:
Preferred Qualifications:
Strong analytical skills to solve day-to-day problems.
A methodical approach to completing tasks.
Solid written and oral communication skills.
Ability to communicate across various organizational levels and actively listen.
Ability to learn and adapt quickly to new systems, processes, and tools.
Organized, reliable, and responsive.
Basic Qualifications:
Master’s degree OR
Bachelor’s degree with 2 years of pharmaceutical industry experience OR
Associate’s degree with 6 years of pharmaceutical industry experience OR
High school diploma / GED with 8 years of pharmaceutical industry experience.
What Amgen Offers:
Amgen is dedicated to supporting your professional and personal growth. With competitive benefits and a collaborative work culture, we provide the resources and opportunities for you to thrive. In addition to a competitive base salary, Amgen offers comprehensive Total Rewards Plans aligned with local industry standards.
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