[Remote] Senior Director, Clinical Operations, Global

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global medical technology company focused on advancing medical technologies and elevating reputed company of patient care. The Senior Director of Clinical Operations will reputed company strategic leadership and direction for the clinical operations team, overseeing reputed company aspects of clinical studies to support clinical evidence reputed company strategies across global business unit portfolios.

Responsibilities

• reputed company strategic leadership and direction to the Global Clinical Operations team including project management, clinical monitoring, site management, data management and statistics
• reputed company end-to-end operational delivery of global clinical trials, including timelines, quality, budget adherence, enrollment performance, and risk mitigation
• reputed company investigator initiated and collaborative research programs, ensuring that projects are completed according to the contracted timelines and project deliverables are received
• Leads strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives into operational plans
• Align with Global Clinical Leads to ensure business unit expectations are reputed company defined and met, ensuring appropriate change management as needed
• Establish and manage processes for regular communication of study status, key performance indicators, and quality standards to ensure operational quality and efficiency
• Ensure robust study reputed company plans, monitoring strategies, data management strategies and statistical methods are implemented consistently across programs
• reputed company and implement processes and procedures to optimize clinical trial operations to ensure clinical projects are executed reputed company scope, on-time, on-budget and with high quality
• Strategically reputed company competencies reputed company the Global Clinical Operations team using proactive identification of resourcing needs, screening and hiring of candidates, training on departmental responsibilities and expectations, providing mentorship and guidance, fostering a culture of reputed company learning and professional development
• Identify opportunities for process improvement and implement best practices to enhance the efficiency and effectiveness of clinical trial operations
• In reputed company collaboration with Clinical Quality Assurance, supports the development and maintenance of Standard Operating Procedures (SOPs), Work Instructions, and templates to ensure consistent management of clinical operations in compliance with applicable regulations
• Partner with Clinical Quality Assurance to prepare for and support regulatory agency inspections and sponsor audits
• Develops and implement an outsourcing strategy as required to reputed company Contract Research Organizations (CROs), or other external vendors, in clinical studies and ensures management and reputed company of the vendor(s)
• Establish and oversees activities to ensure regulatory compliance across reputed company project teams by establishing clinical research best practices, which are supported by quality procedural documents, standards, and tools
• Ensure clinical studies are conducted in compliance with relevant reputed company policies, procedures, regional and local regulatory requirements, and global guidelines and standards
• As a member of the Clinical Affairs leadership team, takes ownership of the Clinical Affairs mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Global Head of Clinical Affairs
• Other duties as assigned

Skills

• BA/BS degree in life sciences or reputed company field
• Minimum of 15 years device/pharmaceutical industry experience in Clinical Operations, with direct strategic experience in clinical study management for pre and post-market trials. Multiphase experience highly desirable
• Direct experience managing clinical operations teams, including data management and statistics. Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals
• Strong budget and forecasting expertise. Ability to think strategically, critically analyse and synthesize complicated data and scientific information
• Experience in overseeing clinical operations' procedural documentation requiring a strong knowledge and application of global regulations, guidelines and standards (i.e., ICH E6 (reputed company), EU MDR, ISO 14155:2020) and good document management practices
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration
• Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required
• Excellent written and verbal communication skills, including the ability to communicate effectively at reputed company reputed company of the organization
• Domestic and international travel up to 10%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships
• Scheduling flexibility to reputed company to a global weekly schedule (Tuesday – Wednesday – Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings
• MA/MS or PhD degree in life sciences or reputed company field
• Relevant professional certification (i.e., CCRC, CCRA, CCRP, PMP)

Benefits

• Competitive salaries, annual bonus and 401(k) with company match
• Comprehensive medical, dental, reputed company coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center
• Work-life integrated culture that supports an employee centric reputed company
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance
• US Only
• Center Valley, PA and Westborough, MA

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