Clinical Manager

  • location: Durham, NC
  • type: Temp to Perm
  • salary: $82.60 - $97.18 per hour
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job description

Clinical Manager

job summary:
Clinical trial project manager overseeing the efforts of a cross-functional project team and accountable for clinical trial project profitability, quality and on-time delivery while striving to exceed client expectations. Respiratory or infectious disease experience desired as well as background in leading large, global projects. Ensure that project staff and functional leads (Clincal Lead, Data Manager, Start-Up Lead, etc.) deliver their respective job responsibilities according to project scope and budget with high quality.

 
location: Durham, North Carolina
job type: Temporary
salary: $82.60 - 97.18 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Clinical trial project manager overseeing the efforts of a cross-functional project team and accountable for clinical trial project profitability, quality and on-time delivery while striving to exceed client expectations. Respiratory or infectious disease experience (particularly large seasonal and / or vaccine trials) highly desirable as well as background in leading large, global projects in a CRO or sponsor company setting. Ensure that project staff and functional leads (Clinical Lead, Data Manager, Biostats Lead, Start-Up Lead, Third Party Vendors, etc.) deliver their respective job responsibilities according to project scope and budget with high quality.

  • Indirectly manage staff in accordance with organizations policies and applicable regulations.
  • Responsibilities include planning, assigning, and directing project team; primary point of contact for sponsor and project-related escalation / issue management; risk and quality management and oversight of project deliverables and team performance.
  • Resource and financial forecasting and management of project finances.
  • Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
  • Participate in the allocation and study-specific training of project resources.
  • Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
  • Proactively identify and manage quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies relative to project delivery.
  • Ensures that project meets defined expectations and operational metrics through regular review and reporting.
 
qualifications:
  • Bachelor's degree in a health care or other scientific discipline or educational equivalent; Clinical Project Management experience or strong Clinical Operations Manager experience.
  • Oncology, Rare Disease, or other complex clinical indication experience
  • Specialized experience: Gene Therapy, CAR-T, Vaccine therapy, First-in Human studies, Phase 1 ONC
  • CRO experience as PL - PL experience at vendors, sites, or labs are more suited to aCPM rather than other positions
  • Compliance oriented experience-QA, CAPAs, quality management, regulatory inspections (local/global)
  • Team oriented, collaborative, organized, pro-active
  • Empowered to make decisions, task ownership/accountability
  • Business understanding and financial acumen
 
skills: Clinical research
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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