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Dir, Strategic Operations

Full Time | Boston | Massachusetts | United States

About the Job

The Head of Strategic Operations in Clinical Operations and Data Management is responsible for the development and implementation of a comprehensive process excellence, training and continuous improvement strategy, and for leading a team of Process Leads and Training Leads and Process Specialists that own and deliver tools and systems that support clinical trials. This role ensures Clinical Operations and Data Management can deliver a holistic strategy through systems, reporting platforms, processes, training, communications and change management tools and methodologies. As a member of the senior leadership team, this role contributes to the overall development and delivery of the department strategy and vision, provides insights to operations for decision making and acts as a hub for process and training innovation within the department.

 

Key Responsibilities

• Team Management - Provide leadership and direction to the Process and Training Leads and Process Specialists.

·   Recruit, manage, train and develop staff.

·   Motivate and manages team members through setting of functional and individual goals, provide on-going feedback and performance evaluations.

·   Delegate and provide general oversight of process development, training delivery and implementation, and management of workforce deliverables.

·   Oversee staff expenditures.

·   Manage resources and budget according to department strategy.

·   Review staff deliverables.

·   Maintain knowledge of HR Corporate policies and procedures.

• Develop and drive process development and training strategy.

·   Develop and drive an innovative process and training strategy in support of efficient, effective and regulated delivery of clinical trials.

·   Proactively identify needs for process standardization, regulatory compliance and areas for improvement.

·   Establish and implement process excellence methodologies, standards and best practices to drive continuous improvements.

·   Partner with cross-functional colleagues to continuously drive improvement and innovation across study and data management processes and systems.

·   Ensure that processes are documented in accordance with established document hierarchy and templates and that training is delivered and recorded in FMI’s learning management system.

·   Manage department learning space with identification of learning needs linked to current Clinical Operations and Data Management strategy and maintenance of associated learning resources.

·   Establish Key Performance Indicators/Key Quality Indicators and implement required dashboards/reports to monitor the effectiveness of processes and trigger process improvement if required.

·   Establish influential and effective partnerships with stakeholders in Alliance Management, R&D, Quality, Technology and Laboratory Operations, and peer partners within Clinical Operations and Data Management.

·   Monitor processes (through performance and quality indicators) and ensure compliance with process, deliverables being met and documentation retained.

·   Sponsor internal initiatives to improve core processes and tools.

• Deliver tools and resources necessary to maintain department infrastructure and operations.

• Improve department infrastructure and operations through provision of staff and tools focused on project management, communication and change management.

• Develop and deliver a resourcing and capacity model.

• Create and execute monthly, quarterly and annual financial, capacity and resource planning with input from leadership in close collaboration with Finance and HR Business Partners.

• Provide planning and coordination for goals/initiatives from development to deployment of deliverables.

• Partner with Technology Team for development, testing and roll-out of new and updated systems.

• Drive analytics and reporting for monitoring of effectiveness and compliance of process landscape and create a flexible metrics platform for quicker reporting.

• Design an agile communications strategy to include the use of visualization tools, multimedia, and social media channels.

• Use core communication and change management methodologies to support delivery of internal and external communication efforts.

• Ensure that communications meet their objectives by establishing and incorporating communications methodologies assessments.

• Ensure communications and change management timelines are prioritized in alignment with department and stakeholder business needs.

• Act as an innovation hub within the department to support experiments and implementation of new design concepts as they relate to our processes, systems and training.

• Maintain knowledge of current GCP and CGP regulations and guidelines and company policies, SOPs and procedures.

• Other duties pertinent to strategic operations as occasionally assigned.

 

Qualifications

Basic Qualifications

• Bachelor’s degree or equivalent in scientific field or equivalent combination of education, training and experience

• 10+ years of Operations experience in a professional life sciences environment

• 5+ years of direct people management or leading a team

 

Preferred Qualifications

• Masters or Advanced Degree in a business or scientific discipline

• 10+ years of Operations experience in the biopharmaceutical or diagnostic industry with a focus on clinical trial and data Management

• Expert knowledge of drug development process and ICH GCP regulations and guidelines as they apply to the conduct of clinical trials globally

• Experience:

·   Influencing and negotiating effective solutions within FMI, with FMI’s partners and/or the wider industry through leading change and driving for results

·   Analyzing and applying strategic-thinking, and problem-solving skills with a proven ability to understand business impact

·   Leading a global team

·   Effectively communicating and leading both with and without authority

·   Successfully managing multiple concurrent initiatives and maintaining one’s own workflow in a fast-paced, dynamic environment

·   Utilizing Microsoft Office Suite

• Demonstrated evidence of success working in a cross-functional environment with ability to build strong relationships

• Highly effective teamwork and collaboration skills

• History of leadership and track record of applying strategic and system thinking

• Demonstrated ability to effectively organize and execute tasks

• Demonstrated ability to work well under pressure while maintaining a professional demeanor

• Understanding of HIPAA and importance of patient safety and data privacy regulations and guidelines

• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration

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Internal applicants, please use your FMI email address.

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