Senior Clinical Project Manager

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Prepare and/or evaluate study-related and essential start-up documents for assigned clinical trials.

• Act as Clinical Project Manager, ensuring that Study Management teams adhere to study timelines and deliverables.

• Supervise and guide study-specific management resources.

• Develop and oversee groups of studies within a business unit or extensive development program.

• Mentor fellow Clinical Project Managers.

• Provide critical thinking and leadership during clinical study execution challenges.

• Draft protocols, clinical study reports, and other necessary clinical study deliverables.

• Lead or participate in continuous improvement initiatives.

• Manage relationships with sites, principal investigators, CROs, and other study-related vendors.

• Create and maintain integrated project plans, facilitating project meetings.

• Define, monitor, and report on schedules, interdependencies, achievements, critical paths, and deliverables.

• Adjust work package deliverables according to study scale and complexity.

• Generate resource and budget forecasts and timelines.

• Direct cross-functional team members and vendors on technical, protocol-specific, and operational aspects of the study.

• Identify and manage project risks and issues, including mitigation strategies and contingencies.

• Uphold high-quality standards and compliance requirements.

• Perform other assigned duties.

⛳️ Requirements

• Bachelor's degree, preferably in the life sciences, clinical, or other relevant technical fields.

• A minimum of 5 years of clinical study experience in pharmaceutical, medical device, IVD, biotechnology, or CRO settings.

• Demonstrated ability to lead cross-functional clinical teams through intricate, global, multicenter studies from initiation to closeout.

• At least 5 years of project management experience, ideally utilizing MS Project.

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

• Practical experience managing Trial Master Files (TMF) in accordance with ICH-GCP and regulatory standards.

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

• Strong financial acumen, including project budgeting, financial forecasting, and strategic recommendations.

• Excellent project management, client relationship, and vendor relationship management skills.

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

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

• Expert-level knowledge of clinical operations procedures.

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

• Strong leadership capabilities.

• Proficiency in Microsoft Office Suite, with expert-level Excel skills including Pivot Tables and VLOOKUP.

• Proven ability to perform effectively in a remote working environment.

• Willingness to travel approximately 20% and reside near a major airport.

• Advanced degree preferred, such as MS, MBA, PhD, MPH, PharmD, or MD.

• PMP certification is highly desirable.

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

🏝️ Benefits

• Comprehensive Total Rewards program.

• Opportunities for rewards and recognition.

• Competitive compensation and benefits offerings.

• Flexible work-life balance options.

• Remote or field-based work arrangements as applicable.

• Opportunities for learning, growth, and development.

• Consideration for COVID-19 vaccination accommodations in accordance with applicable law.