Mgr Clin Ops II

Posted 9 Days Ago
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Seoul
In-Office
Senior level
Biotech
The Role
The position involves supervising direct reports, ensuring regulatory compliance, performance management, training coordination, and maintaining relationships with clients.
Summary Generated by Built In

Job Overview:

Responsible for the supervision of assigned direct reports within PI MS. Responsible for detailed performance review and management of assigned direct reports including Annual Performance Management and Development (PMD) and Individual Development Plan (IDP). Responsible for appropriate management and resolution of performance issues. Effectively communicate management strategies, policies, and procedures in conjunction with leadership teams. Develop and maintain effective relationships with the management team to manage assigned staff in a matrix environment. Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.

    Summary of Responsibilities:

    • Has regulatory oversight of direct reports by ensuring regulatory training is executed, understood and implemented.
    • Escalate issues and follow them till proper resolution.
    • Ensures training record compliance with training matrix and ensures training records are up to date.
    • Provide input to relevant SOPs and standard plans/templates when applicable.
    • Assist with coordination and implementation of on-boarding of new direct reports ensuring GCT training before study-related activities begins.
    • Hold staff accountable for issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans.
    • Hold staff accountable for quality and compliance with project plan and adherence to contract obligations.
    • Coach staff to own effective Investigator relations and Investigator oversight when applicable.
    • Report status of assigned workload of direct reports and ensure allocation reports are updated.
    • Perform weekly review of direct report billable hours and utilization (in context of project allocation, supply and demand); escalate of outliers and assists management team for mitigation.
    • Adheres to global tools for monitoring and utilization forecasting.
    • Assist with staff recruitment through screening and interviewing - Financial authority in accordance with current signature approval matrix.
    • Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports.
    • Liaise with internal and external customers in relevant process improvement initiatives.
    • Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity.
    • Support the company/department processes (e.g., Quality Control Visits) - Identify, develop, and implement measures to improve the efficiency of the department.
    • Responsible for staff time management, PTO and salary reviews.
    • Might be requested to work in a client facing environment.
    • All other duties as needed or assigned.
    • People Responsibilities: 20 Direct Reports.

    Qualifications (Minimum Required):

    • University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory).
    • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

    Experience (Minimum Required):

    • 5 years direct Clinical research experience or combined with other relevant experience (i.e., worked as a Clinical Team Leader/Project Manager at a Pharma company or CRO).
    • Individual proficiency with managing direct reports or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

    Physical Demands/Work Environment:

    • Must be able to sit at a computer for long periods of time.
    • Must be able to use hands to finger, handle or touch objects, tools, or controls, including a computer keyboard, for up to 8 hours per day.
    • Standard office and/or home working environment.
    • Risk of eye strain.
    • Will involve out-of-normal office hours as required by the role.
    • Travel will be for Domestic up to 20% of the time, with 100% of that time requiring an overnight stay.

    Learn more about our EEO & Accommodations request here.

    Top Skills

    Clinical Operations
    Performance Management
    Regulatory Oversight
    Standard Operation Procedures (Sops)
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    The Company
    HQ: Research Triangle Park, NC
    10,811 Employees

    What We Do

    Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network.

    Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.

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