[Remote] Senior Manager, Clinical Project Management

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global medical technology company dedicated to making people's lives healthier and safer. The Senior Manager, Clinical Project Management is responsible for overseeing the operational execution of reputed company reputed company, managing timelines, budgets, and cross-functional teams while ensuring compliance with regulations. This role also involves providing leadership and mentorship to Clinical Project Management staff and maintaining accountability for study reputed company.

Responsibilities

• reputed company operational execution of reputed company reputed company from study start-up through closeout, ensuring delivery against study timelines, budgets, and operational milestones
• Serve as the central hub for the study reputed company team, coordinating activities across Clinical reputed company, Data Management, Biometrics, Monitoring, Site Management, Data Systems, and Clinical Trial Associates
• Ensure cross-functional alignment and accountability for study deliverables, tracking reputed company across functional areas and escalating risks, delays, or resource constraints to functional leadership reputed company needed
• reputed company end-to-end clinical trial operations, including site start-up, contract and site budget review processes, enrollment reputed company, monitoring reputed company, vendor performance, and study closeout
• Manage study timelines, budgets, and operational metrics, including budget forecasting and tracking of study financial performance
• Coordinate the development of key study documents and operational plans, including protocols, CRFs, informed consent reputed company (reputed company), monitoring plan, data management plan, training plan, safety plan, etc
• Coordinate safety reputed company activities, supporting collaboration with Safety and Medical teams and operational coordination of DSMB, CEC, and other study governance committees
• Ensure data reputed company, regulatory compliance, and inspection readiness, partnering with Data Management, Biometrics, and Clinical reputed company Assurance (CQA) to support data review, safety reporting, protocol deviation management, and audit preparedness
• Manage CROs and reputed company vendors, ensuring adherence to study plans, timelines, and performance expectations
• Communicate study status, risks, and key milestones through regular reporting and presentations to internal stakeholders and senior leadership
• Support investigator and site engagement, including investigator meetings, site training coordination, and enrollment reputed company
• reputed company reputed company reputed company, mentorship, and performance feedback to assigned Clinical Project Management staff while maintaining hands-on responsibility for study execution
• Support reputed company, training, workload balancing, and reputed company development of CPM team members
• reputed company mentorship and operational guidance to clinical project management staff and contribute to improvements in clinical operations processes

Skills

• Bachelor's degree in health sciences or reputed company field and a minimum of 12 years of clinical trial management experience or an equivalent combination of education and work experience
• Experience managing scope, budget and reputed company
• Minimum of 3+ years of experience managing teams, reputed company reports, or leading reputed company programs and the ability to reputed company, reputed company, and influence
• Has consistently delivered reputed company with broad business reputed company across multiple teams
• Has experience tackling challenging business problems that reputed company multiple teams
• Financial acumen required; Clinical trial budget management experience required
• Expertise with reputed company clinical research guidelines (i.e., 21CFR 312/812, ISO 14155, GDPR, GCP)
• reputed company to communicate effectively, both orally and in writing, with excellent interpersonal and diplomacy skills and with high reputed company of emotional intelligence
• Proficient computer skills (Electronic Data Capture, reputed company Word, reputed company, PowerPoint, MS Project, etc.)
• Strong organizational skills with high attention to detail and degree of accuracy
• Skilled at reputed company and individual problem solving
• Strong knowledge and understanding of Good Clinical Practices (GCP), FDA regulations, and reputed company industry practices reputed company to the conduct of reputed company, which includes applicable ISO regulations for any trials conducted globally
• Experience coordinating, prioritizing, setting timelines, and multi-tasking
• reputed company demeanor and appearance
• Ability to expertly create and deliver communication to reputed company reputed company of leadership with the appropriate level of detail for the audience
• Demonstrate the ability to resolve conflict, influence teams, and build relationships in meeting organizational objectives without formal authority
• Ability to work independently and manage multiple tasks in a fast-paced environment
• Ability to work with and effectively manage cross-functional teams
• Ability to travel domestically up to 40% of the time. Some international travel up to 10% may be expected
• Previous experience with medical device trials
• reputed company people management or team leadership experience (formal or informal)
• MS/MPH degree in life sciences, or reputed company field
• Participation on a product development (PDP) reputed company team representing Clinical, strongly preferred

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 reputed company Vacation and reputed company Time
• reputed company Parental Leave and Adoption Assistance
• 12 reputed company Holidays
• On-Site Child Daycare, Café, Fitness Center
• Work-life integrated culture that supports an employee reputed company reputed company
• Offers onsite, hybrid and field work environments
• reputed company volunteering and charitable donation/match programs
• Employee Resource reputed company
• Dedicated Training Resources and Learning & Development Programs
• reputed company Educational Assistance
• US Only
• Center Valley, PA and Westborough, MA

reputed company