The Senior Manager for Electronic Trial Operations (ETO) serves as Technical Team Leader and primary point-of-contact to ensure delivery of global ETO services, including overall operational accountability for delivery of Interactive Voice/Web Recognition Systems (IxRS) and Electronic Clinical Outcome Assessments (eCOA) for Amgen clinical trials.
The Senior Manager will lead a team of ETO Technical Specialists responsible for the design, implementation, and maintenance of IxRS solutions for Amgen's clinical trials globally. The role will partner closely with Global Clinical Program Management, Biostatistics, Data Management, Site Management, Supply Chain, and other departments to ensure the delivery of key IxRS processes including enrollment/randomization and drug supply.
Technical oversight of the development, implementation, and maintenance of IxRS functionality to ensure that study-specific ETO solutions adhere to study protocols, Amgen policies, procedures, and standards, and is managed in a regulatory compliant manner.
Lead the strategy of testing and quality delivery of ETO systems in order to ensure commitment to preserving patient safety.
Through active service management of ETO service providers, represent Amgen within a key leadership position, and co-chair Operational Management Team and Functional Management Team governance bodies in partnership with Amgen Global Supplier Services to ensure quality and timely service delivery alongside monitoring supplier performance across IxRS vendors.
Partner with other Data Management System leads to seamlessly ensure high quality deliverables and pursue opportunities, which broaden the use and integration of ETO technologies and services into Amgen's clinical development technologies, systems, and business processes.
Partner and work with outsourced service delivery partners (FSP) while maintaining a high level of transparency between clinical study team members, clinical drug supplies, Clinical Data Management business units, and other stakeholders.
Doctorate degree and 2 years of clinical experience
Master's degree and 6 years of clinical experience
Bachelor's degree and 8 years of clinical experience
Associate's degree and 10 years of clinical experience
High school diploma / GED and 12 years of clinical experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Master's degree in data science, computer science, business administration or related discipline.
Strong leadership skills demonstrating the ability to champion new ideas and challenge the conventional mindset and status quo in order to bring to life improved methods of IXRS services and models in order to deliver unparalleled operational excellence within enrollment/randomization, drug assignments, and drug supply designs.
Exemplary customer service skills, as demonstrated in being able to pivot quickly to emerging or changing business requirements while leveraging business relationships to efficiently deliver system solutions.
Seasoned knowledge and deep experience in the use of IVRS/IWRS system technology and techniques in varying trial dosing/randomization designs.
Understanding of the IVRS/IWRS technical landscape including mobile app technology and vendor platforms.
Excellent communication and listening skills to stakeholders, report community, and stakeholders in order to make thoughtful decisions, which will advance system solutions, influence technical and design positions, and address risks.
Self-driven with a strong work ethic focused on results and high-quality outputs.
Expertise in vendor management and resource management, used to assess workload capacity and monitor functional responsibilities.
Proven technical track record and experience in leading a technical team of staff members and in providing administrative and career development oversight for staff.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.