Clinical Research Operations Specialist

Transforming Lives through Clinical Research is our mission, and as a Clinical Trial Oversight Manager, you will play a pivotal role in making this mission a reality.

You will represent the local functional management team within Global Study Operations Site Management (GSO-SM) and maintain strong collaborative partnerships with all stakeholders to ensure the overall quality of work performed by SM-FSP staff supporting clinical trials.

Your responsibilities will include leading and managing contract responsibilities for both Amgen-sponsored and investigator-sponsored clinical trials. This includes managing contracts, resources, capacity planning, and performance to ensure timely and compliant trial delivery.

Main Responsibilities:

• Primary point of contact for FSP vendors for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues of clinical trials.
• Provide support for clinical study execution, ensuring quality and timely delivery
• Contribute GSO-SM functional area expertise and collaborate with local and global teams in a dynamic cross-functional environment
• Oversight of the site contracting, budgeting and payment process. Supervise, onboard, and train the staff responsible for these processes
• Point of escalation to support resolution of issues equality, staff turnover and performance concerns
• Lead Functional Management Team meetings and contribute to country-level project reviews and process enhancements.
• Conduct on-site quality visits with CRAs where/when appropriate and support the maintenance of clinical site relationships
• Support inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution

We are looking for a leader with the following qualifications:

• Doctorate degree OR Master's degree & 2 years of work experience in life sciences or medically related field, including biopharmaceutical clinical research OR Bachelor's degree & 4 years of work experience in life sciences or medically related field, including biopharmaceutical clinical research OR Associate's degree or qualified nurse (RN) & 8 years of work experience in life sciences or medically related field, including biopharmaceutical clinical research
• Clinical research experience, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting
• Strong background in Clinical Research, including trials, ICH-GCP regulations and guidelines, site management, and roles such as CRA, CTA, or Clinical/Regional Manager
• Leadership in project and team management, including supervisory responsibilities
• Experience working with Functional Service Providers (FSPs) or Contract Research Organizations (CROs)
• Familiarity with Quality Control functions in a biopharmaceutical setting
• Experience with FSP models, clinical systems, and digital tools
• Therapeutic area training with a focus on customer service and stakeholder communication
• Ability to anticipate, troubleshoot, and resolve issues effectively
• Excellent communication skills, with the ability to effectively engage and collaborate with cross-functional teams
• Ability to work effectively in a team/matrix environment on multiple projects
• Advanced English proficiency (written and verbal)

Why You'll Thrive in This Role

This role offers an excellent opportunity to work in a dynamic cross-functional environment, collaborate with global teams, and drive clinical trial success. If you're passionate about transforming lives through clinical research, we encourage you to apply.