Director, Clinical Operations

Contact: Jim Sonnon
Phone: (267) 387-0090

Position Overview

As a member of the Clinical Operations Team, the Director, Clinical Operations is responsible for operational planning and oversight of all study activities and escalates issues when needed from study concept through finalization of clinical study reports. This person will collaborate with cross functional teams to execute clinical study protocols, develop and manage clinical operational, project and study management plans while adhering to budget, scope and schedule requirements. This person will develop study performance matrix and management plans. This person will manage the project activities including but not limited to: clinical monitoring, data management, statistical analysis, medical writing, safety monitoring and compliance to insure proper conduct and timely completion of all projects.

Key Responsibilities

  • Manage all clinical aspects of the clinical program including:
    • Plan, execute and manage all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets and timelines;
    • Develop/manager the following program-specific documentation:
      • study timeline and budget
      • risk management plan
      • educational/training plans
        • KOL/advocacy engagement plan
      • publication and congress plan
    • Develop/manager the following study-specific strategy tools and processes:
      • investigator/site/country/patient recruitment plans
      • request for proposal [RFP] process
      • vendor specifications
      • communication plans (including site and sponsor communication as well as site escalation)
      • ongoing data review plans
      • risk management plans
      • study timeline and budget
      • educational/training plans
      • publication and congress plan
      • performance and compliance metrics
    • Develop and review the following study-specific operational forms and tools:
      • clinical protocols and amendments
      • informed consent templates
      • site feasibility questionnaires
      • case report forms [CRFs] and CRF guidelines
      • data / integrated voice recognition system [IVRS] management plans
      • Investigative site binders, pharmacy brochures, and regulatory binders
      • serious adverse events [SAEs] forms
      • statistical analysis plans and data monitoring committee charters
      • clinical study reports
    • Collaborate with internal departments and/or clinical research organizations [CROs] to ensure timely review of the confidential disclosure agreements [CDAs] and clinical trial agreements [CTAs];
    • Manage clinical program/study budgets in conjunction with function head, Project Management and Finance;
    • Represent clinical study team for study planning and maintenance activities with external vendors
    • Support selected investigative sites for IRB/IEC submissions, regulatory document collection and review, and budget and contract negotiations in collaboration with Legal and CROs;
    • Manage and resolve study conduct issues (including protocol deviations, data queries, SAEs/AEs, laboratory discrepancies, and archive reconciliation activities) as applicable;
    • Plan, execute, and lead study-specific meetings (e.g., Study Management Team [SMT], investigator meetings, advisory committee, etc);
    • Provide study-specific training and leadership to internal staff, CRO, sites, and other contract personnel;
    • Prepare and present program debriefings, as required.
  • At the discretion of the function head, perform periodic site monitoring and vendor audit activities in accordance with protocol, monitoring plan, and ICH-GCP guidelines including:
    • Perform Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-out Visits according to applicable company standard operating procedures [SOPs], regulations, and requirements of ICH-GCP;
    • Complete visit report and investigator correspondence documenting visit progress and issue identification and reconciliation;
    • Adequate follow-up with investigative sites as needed to ensure the identified study conduct issues are resolved and reconciled.
  • Participate in and lead departmental initiatives as requested.
  • Contribute to SOP development

Key Requirements

  • A minimum of a Bachelor’s degree in a scientific discipline or equivalent RN/BSN nursing degree (other majors considered with relevant work experience); advanced degree preferred
  • Typically, 10-15 years of related clinical trial experience with the last 3 years of experience in Pharmaceutical, Biotech or CRO company. Experience in operationalizing clinical trials in neurological or oncology indications preferred. Candidates must have proven track record for delivering multi-center global clinical projects within time, budget, and quality expectations.
  • ICH-GCP and FDA regulatory requirement understanding and competency.
  • Strong clinical study management skills, including risk assessment and contingency planning.
  • Ability to approach assigned duties in a highly organized, detailed and accurate manner.
  • Ability to manage multiple priorities and work in a flexible, dynamic, and fast-paced environment.
  • Excellent oral/written communication, organizational, problem solving and conflict resolution skills.
  • Willingness to travel as dictated by assigned project requirements (approximately 25%). International travel may be required.
  • Ability to work cross-functionally with other departments involved in the conduct of a clinical study.
  • Ability (experience preferred) to work with cross-cultural teams including personnel from global locations as required per project with a positive attitude.
  • Microsoft Project, Office, PowerPoint and Excel proficiency.

Location(s)

Remote

If interested, please send a MS Word version of your resume to [email protected]

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