Everest Clinical Research

Senior Clinical Project Manager

Everest Clinical Research

full-time

Posted on:

Location Type: Remote

Location: Remote • New Jersey • 🇺🇸 United States

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Job Level

Senior

About the role

  • Take a leadership role in facilitating the efforts of functional area directors and managers in project planning
  • Manage projects from initiation through closure for full scope regional and global projects
  • Perform project progress tracking for responsible projects using project planning and tracking methods, tools, and software
  • Provide monthly project progress status reports for individual ongoing projects
  • Prepare project status reports and maintain accurate and current details
  • Present project status to internal and external stakeholders inclusive of comprehensive risk identification and sound mitigations
  • Conduct responsible project progress status meetings with individual project teams periodically
  • Work with the functional area directors and managers to jointly ensure smooth project start-up, continuation, and successful completion
  • Act as the project management lead interfacing with clients to drive project delivery, communication, problem solving, and issue management
  • Coordinate activities between Everest and trial Sponsors, and with various supporting groups or vendors when necessary
  • Lead cross-functional project teams.

Requirements

  • Bachelor of Science or Master of Science in life sciences or health related field
  • Over 10 years of experience in clinical research and development within a pharmaceutical, biotechnology or Clinical Research Organization (CRO) setting
  • Minimum of 7 years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks
  • Pain Management experience is required
  • Knowledge of clinical research process inclusive of Phase I trials through regulatory submission
  • Previous experience as a clinical trial monitor with experience in initiating, monitoring, and closing out clinical trials is desirable
  • Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations
  • Demonstrated understanding of cross-functional processes including site selection, study start-up clinical operations, statistics and statistical programming, data management, subject randomization and drug supply management (IWRS), data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing
  • Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets
  • Solid financial acumen including the ability to define scope and estimate budgets, and plan and manage projects, including resource requirements and utilization, hours spent vs. budgets, key deliverables and timelines
  • Ability to identify out-of-scope work and initiate change order discussions with vendors and Sponsors alike
  • Excellent interpersonal and oral and written communication skills
  • Demonstrated strong negotiation and presentation skills
  • Strong ability in problem-solving including conflict resolution.
Benefits
  • Flexibility in working arrangements
  • Professional development opportunities

Applicant Tracking System Keywords

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

Hard skills
project managementclinical researchclinical project managementPhase I trialsregulatory submissionstatistical programmingdata managementvendor managementmedical writingbudget management
Soft skills
leadershipinterpersonal communicationoral communicationwritten communicationnegotiationpresentationproblem-solvingconflict resolutiongoal settingresource management