Manager, Clinical Operations

🕒 September 18

🌵 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

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 13%

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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 and develop a team of Clinical Project Managers, ensuring study teams meet or exceed timelines, quality standards, and deliverables • Establish team objectives, performance expectations, and development plans; monitor performance and alignment with organizational priorities • Provide management oversight and review of study-related and essential study start-up documents • Oversee and optimize allocation of study management resources • Coach, mentor, and support the professional growth and career development of Clinical Project Managers and Senior Clinical Project Managers • Oversee development and review of protocols, clinical study reports, and other clinical study deliverables • Lead continuous improvement initiatives enhancing study execution efficiency, quality, and compliance • Support internal audits through audit investigations, root cause analyses, and corrective and preventive action (CAPA) plans • Foster collaborative relationships with sites/PIs, internal stakeholders, study-related vendors, and CROs • Apply advanced project management principles to maintain integrated project plans covering scope, schedule, cost, resources, quality, communication, risk, and escalation • Facilitate cross-functional discussions and decision-making • Monitor, evaluate, and report key performance indicators, study milestones, and operational metrics • Identify, assess, and mitigate study execution and compliance risks; escalate and resolve issues • Adapt study management deliverables based on study scale and complexity • Create resource and budget forecasts and timelines • Collaborate with internal and external representatives to provide strategic direction to assigned clinical programs • Oversee Trial Master File activities to ensure completeness, inspection-readiness, and timely archiving • Manage multiple clinical studies from planning and protocol development through conduct and closeout in compliance with Good Clinical Practices and applicable regulations

🎯 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, including international clinical research guidelines and regulatory requirements • Hands-on experience managing the Trial Master File (TMF), ensuring accuracy, completeness, timeliness, and inspection-readiness in compliance with ICH-GCP and regulatory standards • Ability to influence cross-functional teams without formal authority and collaborate to meet project goals, timelines, and deliverables • Strong financial acumen, including developing and maintaining project budgets, forecasting financial needs, and providing strategic recommendations • Successful project management skills with 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 and ability to resolve complex cross-functional issues • Exceptional problem-solving, organizational, analytical, and critical-thinking abilities • Ability to build relationships and communicate across organizational levels and with customers • Proficiency in Microsoft Office Suite, including Word, PowerPoint, Outlook, Teams, and expert-level Excel skills such as Pivot Tables and VLOOKUP • 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 • Minimum of 2 years of people and team management experience highly preferred • Experience in technical and/or medical writing • Ability to travel up to 30% domestically in the US and internationally

🏖️ Benefits

• Annual Bonus • Health and Well-being Benefits • Medical coverage • Health Savings Accounts • Flexible Spending Accounts • Dental coverage • Vision coverage • Hospital Care Insurance • Critical Illness Insurance • Accidental Injury Insurance • Life and AD&D insurance • Short-term disability coverage • Long-term disability insurance • 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 leaves • Military leave • Personal leave • Family and Medical Leave (FML) • Jury and Witness Duty Leave