Clinical Application & Analytical Services Manager
This position will be responsible for Electronic Data Capture (EDC) operational study deliverables, including safety integration setup, script execution, and analysis/reporting. The successful candidate will have a background in EDC systems and be a strong leader with demonstrated ability to influence stakeholders, to engage cross-departmentally, and to partner with the EDC vendor to ensure delivery of services. The candidate should be technologist with a desire to learn and adapt to a changing technology ecosystem.
Responsibilities include, but are not limited to, the following:
- Serve as the EDC technical liaison with study teams to gather/review business requirements
- Develop electronic SAE integration specifications between the EDC system and safety database
- Execute standard database scripts for study milestones
- Facilitate rapid issue resolution and keep stakeholders informed
- Assist in preparing for and responding to audit findings (internal or external)
- Partner with the EDC vendor for the development of customized scripts, reports, or datasets
- Partner with the EDC provider to deliver solutions to support critical business processes
- Build effective relationships and partnerships within Global Development Operations (GDO), IS, Global Statistical Programming, Global Safety, Compliance, Quality Assurance, Functional Service Provider (FSP) and EDC vendors.
- Lead or contribute to system related or process improvement initiatives at the departmental, cross-departmental, or wider Programming, Analytics & Solutions organization.
- Ensure documentation is consistent with established processes and SOPs.
- Delegate tasks to assigned staff, FSP, or contractors that support larger deliverables and projects
- BA, BS, RN degree in the life sciences, computer science, business administration or related discipline
- 5 years of experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company)
- Strong understanding of the concepts of clinical research and drug development
- Hands-on experience working in Medidata Rave EDC or another EDC
- Knowledge of EDC platform configuration settings
- Experience leading technical projects
- Experience with EDC safety module configuration/setup to electronically transfer SAEs
- Working knowledge of E2B guidelines and implementation
- Experience with other clinical trial technologies (RTSM/IVR, CTMS, eTMF, ePRO, eCOA, Argus) along with integration design practices.
- Must be able to work in a global team-based matrix environment (multi time zones)
- Strong project management skills with commitment to timeline management.
- Strong problem solving and decision-making abilities
- Negotiation skills to influence decision-making
- Detail oriented and thorough
- Working knowledge of programming languages (e.g., SQL, SAS)
- Knowledge of other EDC areas including study design, programming, coding, role/user management, report development, and data exports
- Experience authoring work instructions and guidance documents
- Experience with validation documentation and best practices
- Working knowledge of or direct data management experience
- Experience with internal and external inspections
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Knowledge of decentralized clinical trials and emerging automation technology in the pharmaceutical/biotechnology industry
- Knowledge of data sharing mechanisms (e.g., API, webservices)
- Experience with visual and analytical reporting to support trial performance and data activities
US Basic Qualifications:
Masters degree and3 years of clinical experience
Bachelors degree and5 years of clinical experience
Associates degree and10 years of clinical experience
High school diploma / GED and 12 years of clinical experience
Join UsIf 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.