5912 - Director of Clinical Operations

USA    |     Science/Clinical   |   Part-time
Job Reference: 5912 - Posted 11-Oct-2021

Director – Clinical Operations – FSP - Consultant

Job Responsibilities

  • Oversee a portfolio or program of projects.
  • Ensure assigned studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements
  • Represent the company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
  • Collaborates and consults with client’s other functions to ensure site compliance and delivery according to protocol, ICH/GCP and or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for Clinical Scope.
  • Drives management of the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses
  • Ensures alignment of clinical activities to budget, including identification of out-of-scope activities.
  • Ensure and maintain an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.
  • Apply study specific learning across assigned portfolio of studies/clients.
  • Lead and ensure consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
  • Lead operational input to proposal development and pricing including proposed operations strategy
  • Drive performance improvement, operational efficiencies and innovative strategies
  • Provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert
  • Develop, translates and executes strategies or operational objectives for program or portfolio
  • Ensures quality of the clinical monitoring and site management deliverables within a project and maintains proper visibility of its progress.
  • Ability to develop SOPs and Clinical Management Plan (CMP)/Site Management Plan (SMP).
  • Interacts with the clients and other functional departments related to clinical monitoring and site management activities and deliverables.
  • Participates in business development proposals, defense meetings and proposal development.
  • As required, provides development and delivery of initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. Plans and leads regular clinical study team calls to provide status updates, ongoing training, and accountability to deliverables.
  • Adheres to scope and routinely reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely entry of all operational aspects (required visits/calls, duration, and frequency) according to plan, and to oversee site and study team conduct and identify any risks to delivery or quality.
  • Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
  • Understands the monitoring strategy required for the study and where required participates in the development of the study risk assessment plan. Is accountable for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
  • Develops and executes corrective action plans at site and study level, proportionate to the risks identified.
  • Provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert
  • Utilizes systems and tools to assess Key Risk Indicators (KRIs) and ensures that monitoring visits/calls are occurring in line with CMP/SMP.
  • May evaluate staff competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process.

Qualifications

  • Bachelor s degree or RN in a related field or equivalent combination of education, training, and experience
  • Thorough knowledge of International Drug Development (i.e FDA) and Commercialization regulations and clinical project management procedures is necessary
  • Demonstrated ability to lead and align teams in the achievement of project milestones, demonstrated capability of working in an international environment.
  • Knowledge of basic clinical project financial principles
  • Strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
  • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
  • Moderate travel may be required, approximately 20-30%
  • Work Location: This job can be performed anywhere except in the state of Colorado. Colorado residents will not be considered for this job posting.

What’s in it for you?

Kelly takes pride in supporting the whole person, their family and their future. We understand that in order to thrive, we have to build lasting relationships and provide our employees with endless possibilities for growth. At the end of the day, we know that work is more than making a living – it’s about making a life.

Additional Benefits:

  • Healthcare – Medical, Dental, Vision
  • 401(k) Match
  • Paid Time Off
  • Vacation Purchase Program
  • Tuition Reimbursement
  • PerkSpot – Personal Online Discount Program

About Kelly Services®

Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.

Kelly Services is an equal opportunity employer committed to employing a diverse, equitable and inclusive workforce, including, but not limited to, race, gender, individuals with disabilities, protected veterans, sexual orientation and gender identity. Equal Employment Opportunity is The Law.

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