Manager, Clinical Operations

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Oversee a team and manage various clinical studies, acting as a subject matter expert for assigned clinical projects.

• Strategize, execute, and manage clinical studies conducted by Medical Affairs or Contract Research Organizations.

• Mentor and supervise Clinical Project Managers and Senior Clinical Project Managers.

• Direct intricate studies from protocol development through execution and closure, ensuring compliance with Good Clinical Practices and all applicable regulations.

• Provide strategic guidance for clinical programs and collaborate with cross-functional leaders on business initiatives.

• Assess and formulate early plans and concepts for optimal study execution.

• Lead and develop Clinical Project Managers, ensuring adherence to timelines, quality standards, and deliverables.

• Set team goals, performance expectations, and development plans; track team performance.

• Review study-related and essential start-up documents for quality assurance, compliance, and timely execution.

• Oversee and enhance resource allocation for study management.

• Coach, mentor, and facilitate professional growth and career development.

• Supervise the development and review of protocols, clinical study reports, and other key deliverables.

• Drive continuous improvement initiatives.

• Assist with internal audits, root-cause analyses, and the development and implementation of CAPA plans.

• Maintain collaborative relationships with sites/PIs, internal stakeholders, CROs, and additional vendors.

• Utilize advanced project management methodologies to uphold integrated project plans.

• Facilitate discussions and decision-making across functional areas.

• Monitor, assess, and report on KPIs, study milestones, and operational metrics.

• Identify, evaluate, and mitigate risks associated with study execution and compliance; escalate and resolve issues as necessary.

• Tailor study management deliverables to the scale and complexity of the study.

• Generate forecasts for resources, budgets, and timelines.

• Provide strategic direction for assigned clinical programs in collaboration with internal and external representatives.

• Manage Trial Master File activities to ensure completeness, readiness for inspection, and timely archiving.

• Travel up to 30% both domestically within the US and internationally.

⛳️ Requirements

• A Bachelor's degree is required, preferably in life sciences, clinical, or other relevant technical disciplines.

• A minimum of 7 years of experience in clinical studies within pharmaceutical, medical device, IVD, biotechnology, or CRO settings.

• Demonstrated ability to lead cross-functional clinical teams in planning, executing, overseeing, and reporting on complex, global, multicenter studies from initiation to closeout.

• Proven success in managing complex clinical portfolios and Clinical Operations/Clinical Affairs projects.

• In-depth knowledge of clinical trial concepts, practices, international research guidelines, and regulatory standards.

• Hands-on experience in managing the Trial Master File (TMF) in compliance with ICH-GCP and regulatory requirements.

• Ability to influence cross-functional teams without formal authority.

• Strong financial acumen, including project budgeting and financial forecasting capabilities.

• Proven project management abilities and a keen attention to detail.

• Excellent client and vendor relationship management skills.

• Capacity to work independently with multi-level teams, manage multiple projects, and thrive in a fast-paced, dynamic environment.

• Exceptional written and verbal communication, interpersonal, negotiation, and relationship management skills.

• Expert-level understanding of clinical operations procedures.

• Outstanding problem-solving, organizational, analytical, and critical thinking skills.

• Proven ability to build relationships and communicate effectively across various organizational levels and with clients.

• Proficiency in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams) with expert-level skills in Excel, including Pivot Tables and VLOOKUP.

• Demonstrated ability to collaborate effectively and lead a team in a remote environment.

• An advanced degree is highly desirable, such as MS, MBA, PhD, MPH, PharmD, or MD.

• PMP certification is preferred.

• At least 2 years of experience in people and team management is highly preferred.

• Experience in technical and/or medical writing is advantageous.

🏝️ 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 daycare 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