Lifelancer

Senior Study Manager

Lifelancer

full-time

Posted on:

Location Type: Remote

Location: Maine • United States

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Job Level

Senior

About the role

  • Oversee clinical studies from inception to completion, ensuring adherence to timelines, budgets, and quality standards.
  • Support Global Study Managers and lead specific parts of project execution.
  • Serve as the leader of local study teams on assigned studies.
  • Oversee preferred Contract Research Organization and maintain accurate country-level plans.
  • Liaise with regulatory colleagues to agree on submission strategies and milestones.
  • Collaborate with accountable roles to manage risks in study startup and execution.
  • Manage and oversee study startup processes where applicable.
  • Ensure study delivery aligns with agreed operational plans and timelines.
  • Act as point of contact for all study level queries within the local team.

Requirements

  • 3-5 years of clinical trial study management experience required.
  • Comprehensive knowledge of Good Clinical Practice and regulatory operations.
  • Strong analytical and problem-solving skills.
  • Ability to manage complex processes and adapt to changing technologies.
  • Proficient in verbal and written communication.
  • Fluency in written and spoken English required.
  • Experience in a matrix management environment is essential.
  • Bachelor's degree in a related field is preferred, with relevant operational experience.
Benefits
  • Work remotely with a flexible schedule.
  • Opportunities for professional development and growth.
  • Contribute to meaningful projects that impact patient health.
  • Collaborative work environment with supportive colleagues.
  • Access to innovative tools and technologies in clinical research.
  • Participation in a diverse and inclusive workplace.
  • Competitive salary and performance-related bonuses.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial study managementGood Clinical Practiceregulatory operationsproject executionstudy startup processesrisk management
Soft Skills
analytical skillsproblem-solving skillscommunication skillsadaptabilityleadership