Amgen Sr Manager, EDC Operations in Thousand Oaks, California
The Senior Manager, EDC Operations will report to the Director, Clinical Development Technologies and be an active membership on the CSAR Leadership Team. The role will head the EDC Operations with up to ten (10) team members and is responsible to make vital decisions on enabling new clinical technologies, data integrations and improving system performance and scalability, in strong collaboration with technology vendors, CSAR Study System Services, cross-functional business process leaders and IS technical leaders. Under strategic intent, the role will continue to shape the clinical technology and data integration landscape with emerging decentralized trial technologies to accelerate clinical trial execution with future proofing capabilities.
Provide strong partnership with EDC vendor to maintain the current high-performing EDC platform and continue to improve EDC capabilities and scalability to support high demand of mid-study changes from the innovative (adaptive) study designs (e.g. multi-phase protocols and master protocols)
Provide robust leadership to support emerging decentralized clinical technologies and system integrations (EHR2EDC, IRT2EDC, DCT platform, modern data acquisition into clinical data repository), in collaboration with relevant stakeholders/leaders, to enable next generation of decentralized trials
Provide strong vendor quality oversight and influence on the roadmap of SaaS platforms
Drive consistent technology integration or implementation to study portfolio in partnership with CSAR System Study Services, cross functional business process leaders, technology vendors, Compliance, Information Systems and Privacy Office.
Provide direct support to GCP sponsor inspections, internal process audits (IPA) and service provider audits (SPA).
Oversees a high performing team that delivers platform and study-level data integration or customization needs (e.g. system platform upgrade, configuration, eSAE integration between EDC and Safety system, EHR2EDC, IRT2EDC etc)
Champion change through the mindset of continuously improving technology capabilities and processes by means of innovation, simplification, and/or advancing modern integration and data acquisition capabilities
Primary Responsibilities include, but not limited to, the following:
Perform direct quality oversight on SaaS platforms, decentralized trial technologies and data integrations (e.g. eSAE, eConsent, EHR2EDC, IRT2EDC etc).
Maintain overall health of system platforms, manage vendor performance and service levels through governance meetings and strong vendor relationship.
Expert in Medidata platform capabilities, configurations and system behaviors – Classic Rave, Rave EDC, Coder, Safety Gateway, iMedidata, Cloud Admin and mHealth cloud platform etc
Collaborate with cross-functional members and vendors to proactively support critical study milestones with heavy reliance to technology services (e.g. electronic data transmissions, milestone locks, EHR2EDC etc).
Build effective relationships and partnerships within GDO, IS, Global Safety, Compliance, Quality Assurance, and other key stakeholders and functional service providers
Responsible for staff recruitment and staff career development as well as staff performance in-line with Amgen’s Career Development Plan process.
Provide line management, coaching, creates safe environment that motivates shared learning and brainstorming to expand knowledge base.
The senior manager will be a highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. He or she will have deep leadership experience in managing through conflict/bottlenecks, challenging inefficient practices, and possess an energetic-style to motivate fellow team members towards a common goal.
He or she will have an in-depth technical knowledge in order to lead technical projects, participate in creative design sessions to resolve and/or better EDC related activities or new technologies across the Amgen study portfolio or maintain other IS Supported Systems from a business requirements perspective.
He or she must have a strong agility to learn new technologies/disciplines, adapt to changes that surround the EDC ecosystem, be able to articulate a clear action or design, and collaborate (strong team player management style) with cross-functional stakeholders.
With strong negotiation skills, he or she will be able to address conflict head-on and facilitate rapid resolution to issues.
The ideal candidate will have a proven track record and experience in either working and or leading a technical team with strong oversight in ensuring deliverables remain committed to goal(s) and project timeline.
The candidate will represent Amgen’s business requirements and needs by effective partnering and working with third party service delivery partners such as an technology vendors, ensure operational experience with clinical database management systems (preferably Medidata Rave), and have strong communication skills to maintain a high level of transparency between CSAR, cross-functional business process owners, IS and other stakeholders.
Doctorate Degree OR Master's Degree & 3 years of Clinical experience OR Bachelor's Degree & 5 years of Clinical experience OR
Associate's degree & 10 years of Clinical experience OR High school diploma/GED & 12 years of Clinical experience
Bachelors degree or equivalent in life science, computer science, business administration or related discipline
5 or more years work experience in life sciences or a medically related field
5 or more years of experience in a technical role within clinical data management, clinical development, or IS/IT
Extensive hands-on operational experience and system knowledge of Medidata Rave and/or other Medidata products such as i-Medidata, Safety Gateway, Batch Uploader, Coder etc
Work experience integrating other clinical technologies including but not limited to IRT, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry
Strong project management skills with an attention to detail and commitment to timeline management.
Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study team requirements
Must have sound problem resolution, judgment, and decision-making abilities
Must be able to work well in a global team-based matrix environment with minimal supervision
Experience and ability creating and effectively presenting concepts and materials to senior and executive levels
Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary
Knowledge of ITIL v3 and basic Industry IS best practices
Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable
UK Candidates – Basic Qualifications
- Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.