- Serves as functional resource and subject matter specialist for Medical Affairs Information Management Systems.
- Collects, documents, and manages user, functional, and technical requirements for Medical information management systems for the Cell Therapy business areas.
- Interacts with end users on a regular basis to understand their needs and provide guidance and training on technical solutions.
- Evaluate internal and external solutions to find the best fit.
- Makes recommendations on business process automation and improvement with digital technologies.
- Participates in system release and post-deployment support activities with Quality, System Owners, IT Security, IT Operations, and IT Service Desk.
- Manages application configuration changes following IT Change Management (ITCM) and GxP Change Control procedures.
- Provides day to day application support with managed service teams.
- Troubleshoots technical issues and manages problems through to resolution.
- Develops processes to ensure high availability of supported application systems.
- Documents common resolutions/solutions and application support processes in the IT Service Management knowledgebase.
- At least 8 years of experience working with medical affairs information systems.
- Deep understanding of the late-stage clinical development and commercialization lifecycle with specific focus on Medical Affairs business domain/technologies enabling core functions such as external scientific collaboration management, Real World Data, and their applications in clinical development as well as broad medical inquiry management, and field medical affairs.
- Broad clinical development business and IT capability awareness and hands on experience including global implementation experience with Veeva, Salesforce, iEnvision / Datavision, real world data integration and related analytics, medical platform-based solutions.
- Deep understanding of security and privacy regulations, GDPR, internal/external Audits and CAPA management and anticipate future technology need.
- Must possess excellent customer service, problem solving, troubleshooting, and verbal/written communication skills.
- Work experience and strong knowledge of end-to-end IT software and systems solution delivery from idea conception, design, development and/or configuration, and transition into production support and maintenance.
- Computer System Validation (CSV), and GAMP5 experience a plus.
- Strong focus on process, continuous process improvement and quality to enable innovation.
- Proven track record of working in Agile (e.g., SAFe, Scrum, Kanban) and DevOps ways of working in the IT landscape.
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Sr Analyst III - Santa Monica, United States - Spectraforce Technologies
Description
Job Title: Sr. Analyst
Location: Santa Monica, CA OR Raleigh, NC (Hybrid)
Duration: 6+ Months
About Role:
We are seeking a highly motivated Sr. Analyst to support Medical Affairs on their digital technology needs. You will work with the Information Technology team in supporting our efforts in this exciting new area of cell therapy. This role will work closely with the Medical Affairs functions to deliver technology solutions that meet our critical business needs. This important role requires relationship management, business analysis, and project management skills as well as hands-on technical knowledge for various solutions such as External Scientific Collaboration Management, OL Engagement, Real World Data and their applications in Clinical Development, and among others.
Key Accountabilities:
Preferred Qualifications:
About Us: Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of "human connection," defined by our branding attitude of NEWJOBPHORIA, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require reasonable accommodation.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.
Notice to California Applicants:SPECTRAFORCE is committed to complying with the California Privacy Rights Act ("CPRA") effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting
