Senior Clinical Project Manager

🔥 3 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $117.8k - $188.6k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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BD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

💰 $24M Grant on 2020-07

Healthcare • Manufacturing • Healthcare Insurance

BD (Becton, Dickinson and Company) is a global medical technology company dedicated to advancing the world of health. It focuses on developing innovative technologies, services, and solutions to improve safety and efficiency in healthcare. BD offers a wide range of products including medication management solutions, surgical solutions, cervical cancer screening, drug delivery systems, and laboratory services. The company is also involved in infection risk management and provides advanced clinical insights to enhance patient outcomes. With a commitment to global health sustainability and social investing, BD is a leader in healthcare technology and services worldwide.

📋 Description

• Lead planning and execution of complex IVD clinical studies • Develop study timelines and ensure results are completed on time and within budget • Develop clinical study protocols, informed consent forms, case report forms, and other essential documents • Develop clinical safety plans and clinical study reports for regulatory submission • Develop and track clinical study budgets, review and approve invoices, and manage monthly accruals • Oversee study team deliverables for quality and compliance • Manage external vendors and ensure deliverables meet scope, budget, and timelines • Ensure compliance with company policies, FDA regulations, ISO standards, GCP, and other applicable regulations • Identify potential problems, recommend solutions, and track lessons learned • Monitor, evaluate, and manage study participant safety • Serve as a clinical study subject matter expert on cross-functional project teams • Develop and implement standardized clinical research processes and operating procedures • Create and maintain clinical study documents in the trial master file (TMF) • Interact with investigational sites, vendors, key opinion leaders (KOLs), and consultants • Conduct on-site clinical monitoring activities as needed • Lead and participate in cross-functional team meetings • Prioritize tasks and ensure project milestones are met or exceeded • Prepare and present clinical trial progress reports to key stakeholders • Create and maintain timely clinical study registration updates

🎯 Requirements

• Degree level qualification; or equivalent combination of education and experience • Experience planning and executing complex IVD clinical studies • Knowledge of FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations • Clinical study protocol, informed consent form (ICF), case report form (CRF), safety plan, and clinical study report development experience • Clinical study budget development and tracking, including invoice review/approval and monthly accruals • Vendor management experience • Ability to manage multiple tasks simultaneously • Excellent communication and project management skills • Strong oral and written communication skills • Ability to work independently with minimal supervision • Ability to work as part of a diverse professional team • Clinical study registration experience, including clinicaltrials.gov or global registrations • Ability to conduct on-site clinical monitoring activities as needed • Ability to comply with Waters policies, standards and procedures • Ability to manage study participant safety throughout trials

🏖️ Benefits

• Medical, dental, vision, health savings and flexible spending accounts • Life and disability insurance • Wellness resources • Mental health support • Disease management programs • 401(k) • Deferred compensation programs • Financial counseling • DailyPay • Educational savings resources • Paid time off • Company holidays • Educational assistance • Parental leave • Adoption assistance • Backup care • Caregiving support • Employee assistance programs • Commuter benefits • Pet insurance • Legal services • Associate discount programs • Bereavement, military, personal, family and medical leave • Jury duty leave • Reward and recognition opportunities • Competitive compensation and benefits programs

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