Fortrea

Fortrea

Clinical Quality Operations Manager, FSP

Durham · Senior · Part-time

Sponsorship not specifiedDetected 101 days ago
GCPProject ManagementNegotiationProcess ImprovementPerformance ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingGxP

Stay score

odds of building a lasting career here

37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.

Lottery odds assume a STEM candidate.

Personalize to your clock →

Employer immigration record

from this employer's Department of Labor filings

Green-card follow-through: 33%

Of 6 labor certifications old enough to have been used, 4 expired without the employer filing the next step. Median time from filing to decision: 489 days.91% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

Community outcomes

No reports yet — be the first to help the next applicant.

About the role

  • Responsible for process and performance management related to the delivery of the operational function(s), as assigned.

Responsibilities

  • The Clinical Quality Operations Manager is responsible for overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
  • Facilitating and monitoring CTT oversight of vendors Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies).
  • In addition, the CQOM will work with peers to analyse data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.
  • In collaboration with the CQOL, the CQOM will develop skillsets in order to be able to recognise and appropriately respond to new and emerging risks through the use of technology.
  • In particular this will include developing and maintaining a profound understanding of Good Clinical Practice with respect to digital data management (i.e. use of novel technology within clinical trials).
  • The CQOM will build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness.
  • Operational Quality Management: The Clinical Quality Operations Manager is responsible for overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
  • The CQOMs within a specific therapy area will collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.

Requirements

  • Ability to sit for extended periods and operate a vehicle safely.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Varied hours may be required.
  • Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
  • Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
  • Experience with CAPA and risk management tools.
  • Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
  • Experience with delivering effective CAPA management solutions.
  • Experience with risk management tools and processes within the clinical quality framework.
  • Fluent in English, both written and verbal.

Skills

  • Demonstrated ability to work under pressure and requires minimal supervision.
  • Strong interpersonal and communication skills.
  • Strong negotiation skills and ability to influence stakeholders across functions.
  • Strong analytical skills.
  • Excellent planning and organizational skills.
  • Excellent oral, written and presentation skills.
  • Excellent communication, leadership, and project management skills.
  • ACRP-CP Certification strongly preferred Strategic thinker with strong problem-solving and analytical abilities.
  • Effective in cross-functional collaboration and inspection readiness.
  • Skilled in summarizing audit/inspection findings and delivering lessons learned.
  • Expert knowledge in clinical development, QMS, GCP/ICH, and global regulatory requirements.

Compensation

  • Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) 401(K) Paid time off (PTO

Company info

  • Minimum of eight (8) years relevant clinical research experience in a pharmaceutical company/CRO.
  • Thorough knowledge of drug development process.
  • Thorough knowledge of relevant SOPs, ICH, and GCP guidelines.
  • Thorough project management, change management, line management experience, and quality control experience highly desirable.
  • Individual is familiar with on-site monitoring activities (including pre-study, initiation, routine monitoring, and closeout visits), with on-site monitoring experience being highly desirable.
  • We are currently seeking Clinical Quality Operations Manager!
  • This is a full-time role based in the United States.

Equal opportunity

  • Learn more about our EEO & Accommodations request here.

Visa & Work Authorization

  • Contributes to the development and/ or revision of Sponsor policies, SOPs and training materials
Apply directly at Fortrea →Create a free account for alerts like thisView Fortrea immigration profile

This listing is sourced directly from Fortrea's careers page and normalized into a canonical job model.