POSITION SUMMARY:

The Senior Manager, Clinical Operations serves as subject matter expert and advisor to Clinical Operations and Programs on Monitoring/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 Sr. 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 Clinical Programs and Operations team on site Start-Up, Monitoring, and Site Management (including Trial Operations) aspects of clinical research


• Ensures compliance of clinical sites with regulations and internal procedures


• Provides work direction, guidance, mentoring and support to CRAs, and trial support staff on start-up, site management, clinical trial operations and monitoring practices with continuous improvement objectives of efficiency and quality. Includes but not limited to device accountability, processing of trial payments, eTMF management, processing of clinical trial agreements, trial submission preparation to regulatory agencies etc.


• 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


• Fosters and maintains strong relationships through direct interactions with medical advisors, clinical leaders and trial investigators and their staff.


• Supports negotiation and execution of contracts with hospitals, consultants, investigators, CROs, and other vendors as needed.


• Oversees administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.


• In partnership with Clinical Programs, oversees clinical trial enrollment and data compliance strategies


• 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

BASIC QUALIFICATIONS:

• Bachelor’s degree required.


• At least 10 years of global clinical operations leadership experience in a medical device (preferred) or pharmaceutical/biotech environment


• Direct management of monitoring and site management (CRA) personnel (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


• Experience managing CROs and vendors throughout entire clinical operations life cycle


• 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 25%

PREFERRED QUALIFICATIONS:

• 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


• 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

OTHER REQUIREMENTS:

• 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