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    Mgr Centralized St Op

    Fortrea
    4-6 years
    Not Disclosed
    Bangalore
    10 Jan. 28, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Manager, Centralized Study Operations

    Location: Bangalore
    Category: Clinical
    Job ID: 2426601

    About Fortrea

    Fortrea is a leading global contract research organization (CRO) focused on advancing clinical development through scientific rigor and innovative solutions. Serving pharmaceutical, biotechnology, and medical device customers, Fortrea operates in over 100 countries, offering expertise across more than 20 therapeutic areas.

    Key Responsibilities

    Team Management and Supervision

    1. Supervise assigned direct reports within the department.
    2. Conduct detailed performance reviews, including Annual Performance Management & Development (PMD), Individual Development Plans (IDP), goal-setting, and addressing performance issues.
    3. Address employee relations issues, resolve problems, and approve human resource-related actions in collaboration with management.
    4. Measure and monitor performance indicators for assigned staff.
    5. Identify individual training needs and support training and development initiatives.
    6. Provide coaching and guidance to direct reports, ensuring accountability for quality and compliance.
    7. Develop and maintain effective relationships with stakeholders to foster a positive work environment.

    GCP and Quality Oversight

    1. Ensure GCP (Good Clinical Practice) compliance among direct reports through training, implementation, and monitoring.
    2. Identify and address GCP and quality-related issues, planning and executing corrective actions as needed.
    3. Oversee compliance with training requirements and maintain updated training records.
    4. Provide input on SOPs and standardized plans/templates for clinical operations.
    5. Support onboarding of new direct reports, including delivering key role-specific training (e.g., GCP and quality standards).
    6. Ensure timely escalation of GCP issues to management, sponsors, or QA, as applicable.
    7. Hold staff accountable for adherence to client and organizational SOPs, as well as project timelines.

    Productivity and Financial Management

    1. Monitor and report on workload metrics for assigned staff.
    2. Review direct reports' billable hours weekly, addressing outliers and ensuring alignment with budget plans.
    3. Engage in resource management activities, including staff recruitment and performance monitoring.
    4. Ensure expense management and compliance with travel/home-based policies.
    5. Promote standardized processes and tools to enhance efficiency and productivity.
    6. Participate in process improvement initiatives, including Six Sigma methodologies.
    7. Conduct quality reviews of work and ensure budget compliance.

    Communication and Stakeholder Engagement

    1. Communicate management strategies, policies, and procedures effectively with teams and leadership.
    2. Represent the department in cross-functional initiatives and act as a departmental representative when assigned.
    3. Maintain strong working relationships with stakeholders to identify and pursue additional business opportunities.

    Qualifications

    Education

    • Bachelor's degree or equivalent in a related field.

    Experience and Skills

    • Strong knowledge of GCP principles, clinical operations, and quality standards.
    • Proven leadership and supervisory experience in a matrixed environment.
    • Excellent communication, organizational, and problem-solving skills.
    • Financial management skills, including budget planning and expense monitoring.
    • Ability to prioritize tasks, meet deadlines, and drive performance improvements.

    Why Join Fortrea?

    At Fortrea, we are committed to overcoming barriers in clinical trials and delivering life-changing therapies to patients. Join our innovative, collaborative workspace, where personal and professional growth is encouraged, and make a global impact in the healthcare industry.

    Equal Opportunity Employer

    Fortrea fosters diversity and inclusion in the workforce, making employment decisions based on business needs and qualifications.

    For reasonable accommodation requests, contact taaccommodationsrequest@fortrea.com.

    Visit www.fortrea.com for more information.

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