The GSO DM Systems Manager will serve as the Operational Lead for SAS & Clinical Data Reporting (CDR) service areas. The primary deliverables for the service area includes supporting development and validation of SAS, SAS Business Intelligence (BI), Spotfire, QlikView & Cognos reports. In addition the lead will be responsible for infrastructure management that encompasses of secure file transfer services (e.g. MOVEit), Access management (e.g. FAST) and Business and Systems ownership of Systems applications/ macros. The operational lead will be accountable for the service delivery oversight and process compliance supported by Functional Service Provider (FSP). The Operational Lead will also participate in key work streams within Streamline Clinical Trials, including Optimize EDC and Clinical Data Repository.
The manager will be a highly motivated and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. The manager will command respect from peers and with strong negotiation skills, he or she will be able to address conflict head-on and facilitate rapid resolution to issues. Also has proven capability of overseeing and effective partnership with external vendors or service delivery partners in delivering DM systems support or study deliverables.
- Lead SAS and Clinical Data Programming area (SAS BI, QlikView, Spotfire or Cognos) in GSO-DM.
- Partner effectively with other DM Systems Leads and cross functional leads (e.g. DM Therapeutic Area, Study Management, Global Statistical Programming, Partner services, Data Element Standards Governance, GRAAS, IS) to pursue opportunities in developing business cases, driving and realizing potential operational efficiencies and effectiveness, and improve delivery cycle time and quality.
- Serve as key process expert representing SAS & Clinical Data Reporting (CDR) service remits, in support of key process transformation projects, functional governance groups, and/or cross functional systems integrations.
- Partner with FSP Operational Lead in maintaining consistent compliance to established Amgen processes and best practices for the FSP deliverables.
- Partner with FSP Operational Lead in managing CAPA related to the SAS / CDR quality delivery or compliance issues.
- Provide technical and business process input / expertise on new and emerging technologies/vendors for clinical trial execution.
- Serves as the document author for process SOP or manuals and owner for the corresponding guides and tools (e.g. templates, checklists etc).
- Assist in audit preparation and responding to audit findings (internal or external).
- Contribute and lead process development and improvement projects, both internal and external to the GSO-DM .
- Gather & analyze performance metric dashboards.
- Support programming of blinded data and review of tables and listings of blinded data.
- Mentor and train junior staff.
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
Bachelor's Degree in life science, computer science, engineering, business or related discipline.
4 or more years of experience in clinical operations, clinical development or clinical quality assurance.
Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred.
Knowledgeable in Good Clinical Practices, and FDA regulations necessary.
Candidates demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills.
Experience with previous vendor/client management experience.
Excellent time management and organization skills.
Have sound problem resolution, judgment, and decision-making abilities.
Able to work well in a team-based environment with minimal supervision.