Senior Specialist, Clinical Trial Operations Process Improvement & Innovation

The POC Senior Specialist, role enables innovative approaches and efficient execution of the clinical development pipeline through support of process improvements within GCO, with a specific current focus on study startup.
This role is a member of the Business Performance Management (BPM) team within the overall Performance Operational Capabilities (POC) organization. POC enables innovative approaches and efficient execution of the clinical development pipeline for GCO and/or other organizations within Biogen that impact GCO.
When viewed as a lifecycle, business performance management touches upon distinct yet interconnected areas including: systems, analytics, resource & demand management, Process Improvement & innovation, Training & process adherence, and clinical trial technology. Given the inherent interconnectedness of these areas, the person in this role should be knowledgeable in all areas and being willing to further upskill in order to effectively support the department.
Depending on business need and departmental goals, position may focus on one or all of the interconnected lifecycle areas and therefore requires strong ability to collaborate with other staff in BPM, GCO and other functions within Biogen as necessary. Based on current business needs, this role will focus heavily on process improvements and optimization efforts in the study planning and startup space including protocol development, country/site feasibility, and site activation.

Responsibilities:
• Manages the conduct and implementation of process improvement activities working closely with Business Performance Management Leadership and the Process Owner network to ensure compliance and continuity.
• support the facilitation of cross functional teams in individual process improvement initiatives (e.g. Kaizen, process re-design, process design, root cause analysis, etc.)
• Assist in establishing process performance metrics and goals for a particular process that allow appropriate measure of control and success.
• Establish and maintain robust implementation, control and communication plans for any process improvements.
• Act as a liaison between GCO business functions and the IT function as it relates to improvements/changes to IT systems and technology related matters.
• Collaborates with the Sub-Process owner within the Process Owner Network to ensure that process improvements are handed off and the process operates as designed, has appropriate control measures built in and achieves the required output performance.

3+ years’ experience in clinical operations. Experience with continuous improvement and process improvement initiatives. Familiarity with investigator relationship management, and knowledgeable understanding of clinical operational activities.
Excellent

The POC Senior Specialist, role enables innovative approaches and efficient execution of the clinical development pipeline through support of process improvements within GCO, with a specific current focus on study startup.