Vacancy expired!
- Direct W2 employees only! No 3rd party agencies!
- Manages the end-to-end specifications for the design and build of clinical trial systems needed for a given study or project, including requirements review, testing, deployment, maintenance, and enhancements.
- Accountable to and partners with stakeholders such as Clinical Operations, Biostatistics, Clinical Supplies, Data Management, and Vendor PMs, to deliver high quality and efficiently designed systems.
- Serves as a technical liaison to internal and external stakeholders for escalated system issues.
- Gathers, receives and interprets requirements from end users and documents business requirements.
- Monitors key performance indicators (KPIs) and conducts qualitative analyses to identify root causes for defects and recommends process improvements.
- Identifies process inefficiencies and compliance gaps and participates in process improvement initiatives.
- Acts as a subject matter expert for Systems Operations supported systems.
- Presents effectively to both technical and non-technical audiences, including senior leadership.
- Supports pan-client's projects and systems’ initiatives, while advocating for departmental business needs.
- Works closely with vendor and cross-functional stakeholders to ensure prompt resolution of escalated system issues and provides timely and accurate root cause analysis, escalation, and issue tracking support.
- Working knowledge of SDLC, project management, business systems analysis, and product development.
- Ability to successfully lead a team or project through planning, implementation, maintenance, and decommissioning with little or no oversight.
- Demonstrated leadership and influencing skills across technical and non-technical stakeholders.
- Ability to see the inter-relationship of systems, data flow, and procedures within a project and understand their interdependencies within the company wide ecosystem.
- Experience managing third party vendors in delivering quality products and service per expectations.
- Ability to drive results to successful completion, and proactively share learnings.
- Excellent issue management skills to identify root-causes, and manage corrective/ preventative actions.
- Analytical problem-solving skills to define clear problem statements and apply structured and disciplined methodology to intelligibly solution systems, processes, and issues.
- Comfortable working in a fast-paced, and dynamic environment.
- Proficient in productivity software including: Microsoft Suite, Google Suite, Slack, SharePoint, and Trello.
- Highly effective verbal and written communication skills.
- Diligent team player with attentive and engaging interpersonal skills.
- Strong customer focus.
- Knowledgeable with clinical trial systems and digital health technologies, such as: IxRS, EDC, eCOA, eConsent, CTMS, and Clinical Supply Management Systems, and Wearables.
- Broad knowledge of applied GxP experience in Pharmaceutical / Biotech industry.
- Up-to-date industry knowledge of clinical operations processes and supporting information systems.
- Bachelor’s degree
- 5+ years experience in Biotech/Pharmaceutical industry
Vacancy expired!