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    Manager, Regulatory And Start-Up

    Iqvia
    6+ years
    $89,600.00 - $149,300.00.
    Durham
    11 Nov. 23, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Description: Site Activation and Regulatory Manager

    Job Overview

    Direct and manage all required site activation, maintenance, and regulatory activities for assigned studies or multi-protocol programs. This includes pre-award activities, oversight of the scope of work, budget, and resources to ensure successful project delivery.

    Essential Functions

    1. Site Activation and Maintenance

      • Oversee execution of site activation and/or maintenance for assigned projects, ensuring alignment with the Regulatory & Site Activation (RSU) strategy and adherence to project timelines.
      • Develop, implement, and maintain the Management Plan in accordance with the Scope of Work and Project Plan.
      • Collaborate with global, regional, and country teams to deliver the agreed project scope in compliance with the RSU Management Plan.

    2. Documentation and Compliance

      • Create and/or review technical and administrative documents to support business development and study initiation.
      • Provide regulatory and scientific support to ensure compliance with regulatory requirements.
      • Determine regulatory strategy, address complexity, and propose practical solutions for efficient project execution.
      • Review and negotiate contracts and essential documents to ensure operational efficiency.

    3. Quality and Strategy Management

      • Ensure compliance with quality standards throughout site activation and maintenance phases.
      • Assess the regulatory landscape and disseminate regulatory intelligence to support projects and organizational goals.
      • Guide operational strategy for maintaining clinical study approvals and authorizations.

    4. Leadership and Mentorship

      • Mentor and coach team members to foster professional growth.
      • Lead multi-regional and multi-protocol programs during start-up and maintenance phases.
      • Deliver presentations and training to clients, colleagues, and professional bodies as needed.

    5. Systems and Tracking

      • Maintain internal systems (e.g., CTMS), databases, and tracking tools with accurate project information.
      • Support budget planning, tracking, and monthly reviews for assigned studies.

    Qualifications

    • Education and Experience

      • Bachelor’s degree in a related field required.
      • Minimum of 6 years of clinical research experience, with at least 3 years in a leadership capacity.
      • Equivalent education, training, and experience may be considered.

    • Technical Knowledge

      • Comprehensive understanding of the drug development process.
      • In-depth knowledge of regulatory requirements, standard operating procedures (SOPs), and corporate standards.
      • Proficiency in medical terminology, Microsoft Office, and e-mail applications.

    • Skills

      • Strong leadership, organizational, and interpersonal skills.
      • Excellent communication and negotiation skills.
      • Ability to independently manage new processes, prioritize tasks, and resolve issues.
      • Proven ability to lead and motivate teams in a matrix environment.

    About IQVIA

    IQVIA is a global leader in clinical research, commercial insights, and healthcare intelligence, accelerating the development and commercialization of innovative medical treatments to improve patient outcomes. Learn more at IQVIA Careers.

    Equal Opportunity Employer

    IQVIA is committed to providing equal employment opportunities to all, including veterans and candidates with disabilities. Learn more at Equal Employment Opportunity.

    Compensation and Benefits

    • Base Pay Range (Annualized): $89,600.00 - $149,300.00.
    • The actual pay will depend on factors such as qualifications, skills, experience, and location.
    • Additional compensation may include incentive plans, bonuses, and benefits such as health and welfare programs.

    COVID-19 Vaccination Requirement

    IQVIA requires employees to meet specific COVID-19 vaccination status requirements for certain roles. Learn more at COVID-19 Vaccine Status.

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