Clinical Quality Operations Manager

Clinical OperationsClinical OperationsFull TimeRemoteSeniorTeam 10,001+H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

6 days ago

Salary

$120K - $132K / year

Seniority

Senior

Bachelor Degree6 yrs expEnglishGoogle Cloud Platform

Job Description

Clinical Quality Operations Manager

Fortrea

• Responsible for process and performance management related to the delivery of the operational function(s), as assigned. • Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials. • Single point of contact for clinical trial teams for all activities associated with risk-based quality management (RBQM). • Perform a TA-level review of quality plans and risk mitigation approaches to identify any emerging signals or trends. • Responsible for ensuring comprehensive oversight of all activities delegated to third parties. • Facilitating and monitoring CTT oversight of vendors. • Developing, reviewing and revising quality agreements with business partners. • Ensuring essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organisations. • Facilitating and overseeing responses to audit and inspection observations as appropriate. • Analyzing data across therapy areas in order to identify signals and trends and then developing and implementing appropriate process improvement strategies. • Maintaining current regulatory inspection knowledge regarding GCP inspections by regulatory agencies worldwide. • Contributing to the development and/or revision of Sponsor policies, SOPs and training materials. • Developing the strategy for management/support for GCP inspections of Sponsor products.

Job Requirements

  • 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.
  • 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.
  • Experience in Risk Management and Quality Management in Phase I.
  • Relevant clinical research experience in a pharmaceutical company or CRO: 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.
  • Relevant quality management experience: Detailed knowledge of all aspects of GCP guidelines and regulations.
  • Demonstrated ability to separate critical from non-critical GCP issues.
  • Demonstrated effectively balance quality and speed in complex situations.
  • Relevant leadership and process skills: Demonstrated ability to work in a team environment.
  • 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.

Benefits

  • Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
  • 401(K)
  • Paid time off (PTO)
  • Employee recognition awards
  • Multiple ERG’s (employee resource groups)

Related Categories

Related Job Pages

More Clinical Operations Jobs

Full TimeRemoteTeam 10,001+Since 1956H1B Sponsor

• Manages staff, providing coaching, mentorship and work direction. • Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. • Interviews, recruits and selects staff. • Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. • Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports. • Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. • Raises appropriately any issues which may impact project deliverables. • Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate. • Assures adherence to good ethical and regulatory standards. • Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. • Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. • Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable. • Participates in process improvement/development initiatives. • Ensures understanding and facilitation of the risk-based monitoring approach. • May provide input into bids and contribute to the procurement of new business where required. • Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. • May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

Hungary
Part TimeRemoteTeam 51-200Since 1990

• Oversee all aspects of first-year clinical education in the Older Adult, General-Medical, and Medical-Surgical clinical practice settings • Manage clinical operations, supporting faculty and students • Maintain strong partnerships with industry partners, ensuring a high standard of clinical education • Support the recruitment, onboarding, and orientation of Clinical Practice Faculty • Provide leadership, guidance, and performance oversight to Clinical Practice Faculty and staff • Identify and address faculty development needs, oversee performance evaluations, support administrative coordination • Facilitate prep sessions for Year 1 student success in clinical practice • Ensure high-quality, compliant Year 1 clinical placements through careful site selection and documentation oversight

Canada
$69K / year
Healthwaze logo

Clinical Operations Manager – Provider Onboarding, APP Support

Healthwaze

Locum Tenens and Permanent Physician Recruitment and Staffing

Full TimeRemoteTeam 1-10H1B No Sponsor

• Lead provider implementations from contract execution through successful go-live. • Provide operational leadership, mentorship, and ongoing support for Advanced Practice Providers (APPs). • Coordinate provider onboarding, credentialing milestones, EMR access, orientation, training, and start readiness. • Serve as the primary operational liaison between providers, facility leadership, and internal departments. • Partner with recruiting, credentialing, scheduling, billing, payroll, and medical leadership to ensure seamless execution. • Build and maintain strong relationships with hospitals, inpatient rehabilitation facilities, skilled nursing facilities, and post-acute care partners. • Identify operational challenges, implement process improvements, and drive successful outcomes across multiple facilities. • Promote provider engagement, satisfaction, and retention through proactive communication and support. • Must be willing to Travel

United States
$125K / year
Full TimeRemoteTeam 10,001+Since 1990H1B No Sponsor

• Develop and execute accurate operational development plans for assigned clinical trials, aligning with budget, timelines, and standard operating procedures (SOPs) • Oversee the management of clinical studies, including compliance with corporate, regulatory, and quality standards. • Lead clinical operations personnel, contract research organizations (CROs), consultants, core laboratories, and other study support organizations. • Handle program-level activities as assigned, ensuring operational plans are implemented effectively. • Ensure adherence to ICH-GCP, GPP, Incyte SOPs, and applicable country-specific regulations. • Work cross-functionally with internal teams (e.g., Medical Affairs, Medical Science Liaisons, Medical) and external partners to support trial goals and timelines. • Monitor site performance, feasibility, and study execution for assigned trials.

Pennsylvania
Job Closed