Sr Manager to Assoc Director, Clinical Process Excellence

Reporting to the Senior Director of Clinical Operations this role is responsible for drafting, developing, and creating global standards, processes, and guidance documents to improve consistency and alignment across Clinical Operations organization. The individual will work cross-functionally to develop, deploy, and maintain tools as part of clinical study management. The individual will serve as a key collaborator within the department and will support team member training and process improvement initiatives. This position is a key contributor to development and execution of continuous improvement initiatives, KPI and dashboard development, best practices in clinical study processes, operational excellence principles. To achieve this, it will be critical that this position effectively work cross-functionally to meet business objectives and build the foundations to drive continuous, sustainable, flawless execution and performance improvement.

This position is unique. The Process Excellence function is new and we are building a team. The vision of this function is to support Inspection Readiness and to ensure efficiency in the clinical study management space. We believe the best candidate for this role is someone who has experience in clinical study management or Quality-GCP functions and wants to utilize that experience in a new way.

What will be your responsibilities?

• Responsible for drafting, developing, and creating governance, processes, and/or guidance documents to improve consistency and alignment within Clinical Operations and Clinical Trial Teams (CTTs).
• Assist with the development and implementation of tools, guidelines, and training for study-related processes, including presenting at team meetings and other cross-functional forums.
• Support and manage clinical operations onboarding and offboarding tools.
• Leads quarterly Key Performance Indicator (KPI) Smartsheet update within Clinical Operations, which includes leading 1:1 meeting with COSLs, building, and adjusting templates, monitors, and tracks trends for progress and impact, and ensures accurate and meaningful information is being distributed to the Clinical Quality Council.
• Manages the Clinical Operations Tool Kit, reviewing and approving ongoing submissions, while maintaining annual or quarterly reviews of current documents.
• Ensure Clinical Operations Leadership is aware of upcoming audit schedules (planned by Quality team). Support audit processes and function as central contact for the Quality team.
• Capable of acting as SME for initiatives in conjunction with the Clinical Operations Leadership Team, as required, to ensure consistent implementation of best practices across related activities and studies.
• Independently manage assigned projects and report on status/outcomes of the project. Examples include investigations into performance metrics and analysis of data.
• May serve as a resource for COSLs if gaps or inconsistencies in study management arise, leading the effort to gain alignment and clarity through informed decision making with key stakeholders.
• May conduct post-study retrospective assessment to identify areas for improvement and lessons learned.
• Track progress on the Clinical Operations Department Initiatives and report to CO Leadership. May serve as project lead for assigned dept. initiatives.
• Serve as a cross-functional reviewer on standard procedures and collaborate with SMEs as part of the business process function.
• May lead risk management activities across studies,
• May assist with organizational training activities, such as conference attendance tracking, assisting with outside opportunities for learning, as well as working cross functionally with other departmental leads to ensure proper understanding activities and responsibilities.
• Drive consistency and standards across portfolio in collaboration with key functional stakeholders.
• Contribute to integration activities across the portfolio.

Education:

• Minimum Education Required: bachelor’s degree.
• Scientific degree is preferred.
• PMP certification is desirable but not required.
• 6-8 years of experience for Sr. Manager/Minimum 8 years of experience for A.D.
• The candidate should ideally have 5-8 years of clinical research experience in the pharmaceutical industry with a solid understanding of technology and processes used in drug development, three of which involved in the planning and execution of global clinical trials.

Skills:

• Experience in training, process improvement, and project management skills.
• Deep experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, project management) required.
• Strong leadership, collaboration, influencing, and change management skills in a complex, matrix environment including team leadership or project management required.
• Experience in clinical trial process design and improvement activities, harmonization/optimization, and training and implementation required.
• Detailed knowledge of GCP and current US FDA regulations, and knowledge of other relevant global regulatory requirements.
• Work with a high degree of autonomy and proficiency in approach to problem-solving
• The duties of this role are conducted in an office environment.
• Experience or exposure to clinical trial conduct in multiple phases of development across multiple therapeutic areas, including oncology and rare diseases.
• Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.).
• Strong customer service-minded and an inspiring attitude to champion change across the organization.
• Creative problem solver with excellent communication and public speaking skills.
• Resourcefulness/Flexibility – The ability to adapt to working optimally within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.