Manager, Clinical Operations

Job not on LinkedIn

🔥 3 minutes ago

🌵 Arizona, California, +3 more states – Remote

🌵 Arizona – Remote 🏄 California – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote 🤠 Texas – Remote

💵 $137.5k - $220.1k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 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

• Manage a team and multiple clinical studies, serving as a subject matter authority for assigned clinical studies • Plan, implement, project-manage, and complete clinical studies conducted by Medical Affairs or Contract Research Organizations • Mentor and manage Clinical Project Managers and Senior Clinical Project Managers • Lead complex studies from protocol development through conduct and closeout in compliance with Good Clinical Practices and global, national, and local regulations • Provide strategic direction for clinical programs and collaborate with cross-functional leaders on business requests • Evaluate and develop early plans and concepts for optimal study execution • Lead and develop Clinical Project Managers, ensuring timelines, quality standards, and deliverables are met • Establish team objectives, performance expectations, and development plans; monitor performance • Review study-related and essential start-up documents for quality, compliance, and timely execution • Oversee and optimize study management resource allocation • Coach, mentor, and support professional growth and career development • Oversee development and review of protocols, clinical study reports, and other deliverables • Lead continuous improvement initiatives • Support internal audits, root-cause analyses, and CAPA plan development and implementation • Maintain collaborative relationships with sites/PIs, internal stakeholders, CROs, and other vendors • Apply advanced project management methodologies to maintain integrated project plans • Facilitate cross-functional discussions and decision-making • Monitor, evaluate, and report KPIs, study milestones, and operational metrics • Identify, assess, and mitigate study execution and compliance risks; escalate and resolve issues • Adapt study management deliverables to study scale and complexity • Create resource and budget forecasts and timelines • Provide strategic direction to assigned clinical programs with internal and external representatives • Oversee Trial Master File activities to ensure completeness, inspection readiness, and timely archiving • Travel up to 30% domestically in the US and internationally

🎯 Requirements

• Bachelor's degree required, preferably in life sciences, clinical, or other relevant technical areas • Minimum of 7 years of clinical study experience in pharmaceutical, medical device, IVD, biotechnology, or CRO environments • Proven ability to lead cross-functional clinical teams in planning, execution, oversight, and reporting of complex, global, multicenter studies from initiation through closeout • Success leading complex clinical portfolios and Clinical Operations/Clinical Affairs initiatives • Strong knowledge of clinical trial concepts and practices, international clinical research guidelines, and regulatory requirements • Hands-on experience managing the Trial Master File (TMF) in compliance with ICH-GCP and regulatory standards • Ability to influence cross-functional teams without formal authority • Strong financial acumen, including project budgeting and financial forecasting • Proven project management skills and meticulous attention to detail • Strong client and vendor relationship management skills • Ability to work independently with multi-level teams, manage multiple projects, and work in a fast-paced, changing environment • Exceptional written and verbal communication, interpersonal, negotiation, and relationship-management abilities • Expert-level knowledge of clinical operations procedures • Exceptional problem-solving, organizational, analytical, and critical-thinking abilities • Proven ability to build relationships and communicate across organizational levels and with customers • Proficiency in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams) with expert-level Excel skills, including Pivot Tables and VLOOKUP • Proven ability to work collaboratively and lead a team in a remote environment • Advanced degree highly desirable, such as MS, MBA, PhD, MPH, PharmD, or MD • PMP certification preferred • Minimum of 2 years of people and team management experience highly preferred • Experience in technical and/or medical writing

🏖️ Benefits

• Annual Bonus • Health and well-being benefits • Medical, dental, and vision coverage • Health Savings Accounts • Flexible Spending Accounts • Hospital Care Insurance • Critical Illness Insurance • Accidental Injury Insurance • Life and AD&D insurance • Short-term and long-term disability coverage • Long-term care with life insurance • Anxiety management program • Wellness incentives • Sleep improvement program • Diabetes management program • Virtual physical therapy • Emotional/mental health support programs • Weight management programs • Gastrointestinal health program • Substance use management program • Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit • BD 401(k) Plan • BD Deferred Compensation and Restoration Plan • 529 College Savings Plan • Financial counseling • Baxter Credit Union (BCU) • Daily Pay • College financial aid and application guidance • Paid time off (PTO), including all required State leaves • Educational assistance/tuition reimbursement • MetLife Legal Plan • Group auto and home insurance • Pet insurance • Commuter benefits • Discounts on products and services • Academic Achievement Scholarship • Service Recognition Awards • Employer matching donation • Workplace accommodations • Adoption assistance • Backup day care and eldercare • Support for neurodivergent adults, children, and caregivers • Caregiving assistance for elderly and special needs individuals • Employee Assistance Program (EAP) • Paid Parental Leave • Support for fertility, birthing, postpartum, and age-related hormonal changes • Bereavement leave • Military leave • Personal leave • Family and Medical Leave (FML) • Jury and Witness Duty Leave