Manager, Clinical Operations
Manager, Clinical Operations
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
The Manager, Clinical Operations serves as subject matter expert and advisor to Clinical Operations and Programs teams on Site Management and Trial Operations related matters. This position oversees performance and trends related to site lifecycle management including initiation, execution and closure, monitoring and trial operations services, ensures applicable regulations and standards for medical devices are applied, and clinical program and department commitments are achieved. This position heavily interfaces and collaborates with other functions and departments within the clinical organization, vendors, and contributes to process improvement activities.
The Manager, Clinical Operations will establish and ensure compliance with standard processes and best practices, in addition to maximizing metrics and reporting on clinical activities.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Acts as a Subject Matter Expert to the Clinical Programs and Operations team in the development and implementation of key study functions, including but not limited to device supply logistics, financial processes (invoices and payments), essential document and trial master file (TMF) management, audit preparedness, credentialing and select monitoring activities throughout the lifecycle of a trial.
- Provides work direction, guidance, mentoring and support to Clinical Study Associates (CSAs), Clinical Operations Associates (COAs) and/or Clinical Research Associates (CRAs), on clinical trial operations practices with continuous improvement objectives of efficiency and quality.
- Participates in the interview and selection of hiring new employees including training and onboarding as applicable
- Provides oversight and direction in the development and management of clinical trial materials (may include ordering, copying, creating tabs, building binders, review binder content, shipping, and tracking of documents associated with department or study supplies and study devices)
- Provides oversight and direction in the development of device processes, and logistics from demand planning, device setup in the clinical database, ordering, re-supply and tracking for clinical sites including quality control and filing of documents, and overall device accountability for assigned trials
- Responsible for tracking trial activity in collaboration with the clinical team, by ensuring receipt of essential documents, including quality control and filing of documents
- Supports Clinical Programs team to track accruals, processing and reconciliation of payments
- Ensures compliance of clinical sites with regulations and internal procedures
- Represents Clinical Operations on department initiatives related to development of policies and procedures, implementation of global clinical quality systems (e.g. eTMF) and regulation changes
- Responsible for applicable trial metrics to ensure timelines, quality and compliance are met
- Oversees administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.
- Partners with cross-functional team members to meet business objectives.
- Ensures that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices.
- Implements best practices and standards for trial execution in collaboration with other members of the clinical operations and programs team, including establishment of procedures (SOPs or WIs).
- Other duties as assigned.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgment
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
- Additional duties as assigned
- Bachelor’s degree required.
- At least 6 years of global clinical operations leadership experience in a medical device (preferred) or pharmaceutical/biotech environment
- At least 2 years of direct management of clinical operations personnel (CRA/CSA), remote and onsite, providing work direction, guidance and mentoring for execution of clinical trials
- Proven experience working with EDC, trial management, reporting and documentation systems
- Proven success participating in cross-departmental (Senior Management, Regulatory, Quality, Program Management, Finance, Medical Affairs, Clinical Development etc.) clinical strategy, planning and implementation activities
- Excellent working knowledge of FDA regulations and expectations, Good Clinical Practice, ICH guidelines and clinical operations best practices for the conduct of global pre- and post-market clinical trials
- Experience working in a cross-functional team setting in different locations and geographical regions
- Demonstrates strong problem-solving, communication and leadership skills
- Demonstrates strong organizational, project management and soft skills
- Proficient in Microsoft office
- Strong team leader with execution focus
- Ability to work independently and to solve complex problems
- Ability to travel 10%
- In-depth understanding of common cardiovascular device product development processes / requirements
- Change agent and collaborative team player
- Direct experience with sponsor, site, and/or vendor preparation for and participation in regulatory inspections, with global experience
- Experience managing CROs and vendors throughout entire clinical operations life cycle
- Proven experience contributing or leading department/organizational initiatives with major impact on process improvement work and/or work efficiencies
- Previous experience with AFib and / or Structural Heart interventional device studies
- Customer focus with ability to develop excellent relationships with internal and external partners
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Ability to pass pre-employment drug screen and background check
- Job Family Clinical Affairs
- Job Function Clinical
- Pay Type Salary
- Employment Indicator People Manager