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Senior Lead, Clinical Project Manager

Clario
NewPosted today

LOCATION

United States · Remote

EXPERIENCE

5 - 10 Years

TYPE

FullTime

SKILLS REQUIRED

Regulatory ComplianceStakeholder ManagementRisk ManagementGood Clinical Practice

Job description

Overview

Lead the delivery of global clinical research projects, providing leadership, governance and operational oversight for studies and the teams that run them.

What you'll do

  • Provide leadership and oversight for global clinical study management and project delivery, keeping projects on schedule, within budget and aligned with contractual obligations.
  • Evaluate study progress, resource allocation and team workload, implementing adjustments and mitigation strategies as needed.
  • Proactively identify, assess and mitigate risks across assigned programs and studies.
  • Manage escalations and resolve operational, client and project challenges, maintaining issue tracking and documentation.
  • Support Clinical Project Managers in client communications regarding study status, risks, timelines and deliverables.
  • Lead cross-functional collaboration with internal and external stakeholders to ensure successful project execution and study completion.
  • Coordinate and facilitate routine status meetings to monitor study progress, resource utilization and key milestones.
  • Serve as Project Manager for assigned studies when required, including oversight of start-up, execution and closeout for complex, high-profile customer programs.
  • Guide study teams to maintain consistency across Therapeutic Areas and programs, promoting operational efficiency and alignment with customer objectives.
  • Partner with senior leadership to prioritize deliverables, address resource needs and communicate critical project updates.
  • Influence strategic decision-making and drive operational excellence through continuous process improvement initiatives.
  • Identify opportunities to improve workflows, tools, procedures and service delivery within therapeutic or imaging teams.
  • Lead departmental initiatives, including planning, execution, communication, training and progress reporting.
  • Serve as a Therapeutic Area and/or Imaging Lead for operational readiness and implementation of new processes and procedures.
  • Monitor operational challenges and recommend solutions to improve study delivery, quality and efficiency.
  • Coach, mentor and develop Project Management team members through performance management, career development and ongoing feedback.
  • Support onboarding and training of new team members while ensuring compliance with required training completion and documentation.
  • Manage team assignments and workload distribution to encourage growth, accountability and high performance.
  • Establish, maintain and enforce departmental standards, SOP compliance and study management best practices.
  • Review and update project management and therapeutic team procedures to ensure quality and regulatory compliance.
  • Perform additional duties, assignments and special projects as required.

What you'll need

  • Bachelor's degree in Life Sciences, Pharmacy, Nursing or a related discipline.
  • 5-10 years of clinical research experience within a CRO, pharmaceutical, biotechnology or related clinical development environment, including significant project management responsibility.
  • Previous people management and leadership experience within clinical development, clinical operations or clinical trial management.
  • Strong knowledge of clinical trial processes, project management methodologies and drug development practices.
  • Working knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines and FDA regulations.
  • Experience supporting global clinical studies and leading cross-functional, geographically dispersed teams.
  • Demonstrated ability to coach, mentor and develop team members.
  • Strong organizational, prioritization, problem-solving and decision-making skills.
  • Excellent verbal and written communication skills, including the ability to communicate effectively in English with internal and external stakeholders.
  • Proficiency with Microsoft Office applications and project management tools.
  • Detail-oriented, with the ability to manage multiple priorities and adapt to changing business needs.
  • Valid passport and ability to travel up to 20% as needed.

Nice to have

  • Master's degree.
  • Medical Imaging experience.

Details

  • Work mode: Remote, United States.
  • Travel of up to 20% as needed.

Read the full description and apply on the company’s own careers page.

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Senior Lead, Clinical Project Manager