Senior Clinical Project Manager (REMOTE) - Princeton, New Jersey United States - 38671



JOB DESCRIPTION

Job #: 38671
Title: Senior Clinical Project Manager (REMOTE)
Job Location: Princeton, New Jersey - United States
Employment Type:
Salary: contact recruiter for details
Other Compensation: 10% Bonus
Employer Will Recruit From: Nationwide
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


Opportunity to join a global CRO focused on Oncology

JOB DESCRIPTION

Well established international contract research organization serving both commercial as well as government markets, is conducting a search for a full time Senior Project Manager

 

As a primary point of contact, the Sr. Clinical Project Manager will interface directly with sponsors and vendors and cross-functional team members and will oversee global phase I – III clinical trials startup through closeout to ensure processes, timelines, contracts, ICH/GCP adherence and quality standards are met.  They will identify and evaluate risks, interpret data on complex issues and implement solutions in order to ensure successful completion of trials.     

 Quality:

  • Establish study-specific oversight plans and ensure adherence and review
  • Ensure protocol deviation meetings are conducted per plan
  • Facilitate internal audit / corrective and preventive action (CAPA) management: contribute to the resolution of CAPA
  • Manage TMF filing of Clinical Operations documentation
  • Conduct or participate in inspections readiness activities in collaboration with QA

Budget:

  • Ensure Quarterly budget review meetings are performed, undertake review of budget and scope of work
  • Work proactively to ensure the study remains within the agreed scope and budget
  • Initiate Change Order (CO) activities as required

Clinical Operations:

  • Proactive management of clinical projects to ensure issues are identified and solutions established
  • Provide oversight, support and guidance for study team through across departments
  • Serve as protocol subject matter expert for assigned study
  • Contribute to the development of standard metrics used to routinely monitor study activities
  • Perform day-to-day management of the study team as required, including leading team meetings and provision of study training updates.
  • May be assigned as a “Program Manager” for multiple studies under a single Sponsor
  • Serves as a mentor and provides guidance to Project Managers, Assistant Project Managers and Clinical Trial Assistants

Study Conduct

  • Monitor study enrolment and retention. Act on deviations from plansIdentify barriers to enrolment and support recruitment and retention strategic solutions
  • Monitor and act upon study metrics (review, trend-identification and analysis, with targeted follow up where appropriate)Review Monitoring visit Reports
  • Ensure accuracy of information for study presented in status reports (CTMS)

Risk Assessment & Mitigation:

  • Proactively identify and communicate Clinical Operations risks and mitigations and align with study team on overall Risk Mitigation Plan 

QUALIFICATIONS

Qualifications:

  • BSc. required – preferably in a life science field or equivalent 
  • Healthcare professional with at least 5 years of prior project management experience with demonstrated leadership skills in a CRO/pharmaceutical environment, with a track record in successfully managing clinical trial sites
  • Experience of oncology clinical trials and cancer therapies
  • Prior experience in a CRO/pharmaceutical environment required
  • Knowledgeable of the initiation, conduct, and completion of all phases of oncology clinical trials study endpoints, and clinical databases
  • Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and highly effective in developing solutions to those problems
  • Effective in writing reports and varied correspondence
  • Effective knowledge of the drug development process and the Oncology organizational structure
  • Effective knowledge of current projects, including:
  • Protocol and CRF details
  • Study Plans
  • Project-specific scientific knowledge
  • Sponsor requirements (i.e., Sponsor SOPs, contract-specific requirements, etc.)
  • Thorough knowledge of SOPs of Oncology and specific Sponsor
  • Thorough knowledge of current European and North American regulations and any applicable guidelines
  • Highly effective ability to set and meet personal short- and long-term goals
  • Proficient computer skills of MS Office Suite

Additional Requirements:

  • Ability to travel occasionally up to 15% when required, domestic and/or global

Education:
University - Bachelor's Degree/3-4 Year Degree

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