Senior Manager, EDC Study Operations

Thousand Oaks, CA, US
Apr 13, 2021
Required Education
Position Type
Full time
The Senior Manager, EDC Study Operations will report to Director, Clinical Development Technologies and will be a highly motivated, decisive and results-oriented individual along with an in-depth technical acumen in order to lead technical projects and innovative design sessions to resolve and/or enhance EDC study related activities or implement new technologies and/or technical solutions across the Amgen study portfolio. Expects to achieve quality results through rigorous goal setting, accountability measures, effective teamwork, performance management, vendor oversight, collaboration with cross-functional groups and technology vendors.

Role Summary:
  • Provides technical leadership (EDC & beyond) focused on technology enablement, continuous improvement and advancement in study portfolio implementation.
  • Champion change through the mindset of continuously improving technical solutions and processes by means of innovation, simplification, and/or advancing new integrations or technical capabilities in partnership with cross functional business process leaders, technology vendors, Quality Assurance, Compliance, Information Systems and Privacy Office
  • Oversees a technical team that delivers technical study deliverables including data integration needs (e.g. support of Safety Reporting, Site Payments, Data Analytics etc) at the study portfolio level in a consistent and timely quality manner through robust study team collaboration and/or interaction with technical vendors.
  • Staff recruitment, management and development as well as staff performance in-line with Amgen's Career Development Plan process.

Primary Responsibilities include, but not limited to, the following:
  • Provide line management, coaching, creates safe environment that motivates shared learning and inspires innovative ideas.
  • Provide oversight to ensure consistency and quality delivery in study level data integrations between Rave EDC, Rave Safety Gateway, Coder and extended technologies that enable study execution (e.g. eSAE, eConsent, EHR2EDC, IRT2EDC 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 etc).
  • Provide direct support for regulatory inspections, internal process audits (IPA) and service provider audits (SPA).
  • Act in a state of inspection readiness, ensuring timely completion of Trial Master File (TMF) submissions.
  • Manage vendor performance and service levels through governance meetings and strong vendor relationship.
  • Expert in Medidata platform configurations, capabilities and system behaviors. Lead and deliver new EDC capabilities, innovative technical solutions and/or clinical system integrations that enable future proof study execution.
  • Maintain overall health of EDC platform by consistently balancing study-level system activities across the study portfolio.
  • Build effective relationships and partnerships within GDO, IS, Global Safety, Compliance, Quality Assurance, and other key stakeholders and functional service providers.
  • Partner with other functions (e.g. IRT, Study Design Programming, Data Management, GRAAS etc..) to ensure the successful delivery of study system tasks/activities.

Leadership Skills:
  • 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 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 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, influence stakeholders and/or vendors, 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.

Preferred Qualifications:
  • 5 or more years of experience in a technical role within clinical data management, clinical development, or IS/IT; preferably within the clinical research and development industry.
  • Extensive hands-on operational experience and system knowledge of Medidata Rave and/or other Medidata products such as i-Medidata, Cloud Administration, 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 technical 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 FHIR and other standards initiatives desirable

US Candidates - Basic Qualifications
  • Doctorate degree OR
  • Master's degree & 3 years of clinical experience OR
  • Bachelor's degree & 5 years of clinical experience OR
  • Associate degree & 10 years of clinical experience OR
  • High school diploma / GED & 12 years of clinical experience

UK Candidates - Basic Qualifications
  • Bachelor's degree or equivalent in life science, computer science, business administration or related discipline

Join Us

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.