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(Buen Salario) Clinical Operations Leader In Immuno-Oncology

(Buen Salario) Clinical Operations Leader In Immuno-Oncology

Insud PharmaMadrid, Kingdom Of Spain, España
Hace 20 horas
Descripción del trabajo

Overview

Job Title : Associate Director, Clinical Operations

As an Associate Director of Clinical Operations, you will spearhead the planning, execution, and oversight of clinical trials in immuno-oncology and biologics, ensuring timely delivery within budget and quality standards.

Key Responsibilities

  • Develop and oversee the Clinical Development Plan for innovative portfolios, focusing on immuno-oncology.
  • Lead scientific advice interactions with regulatory agencies.
  • Build and maintain relationships with Key Opinion Leaders (KOLs) to validate clinical trial plans and evaluate new pipeline opportunities.
  • Manage clinical trial budgets, including financial oversight of outsourced activities.
  • Plan drug supply for clinical trials, coordinating with global logistics to ensure timely product availability.
  • Strategically select, contract, and manage CROs and external vendors, ensuring performance meets agreed cost, quality, and timeline standards.
  • Identify countries, sites, and investigators for trial execution, optimizing scientific, regulatory, and operational feasibility.
  • Oversee the establishment and coordination of independent committees (IDMC, IRC, etc.), ensuring compliance and documentation for regulatory submissions.
  • Supervise the development and review of essential clinical trial documents (protocols, informed consent forms, amendments) in collaboration with medical and scientific teams.
  • Ensure timely regulatory and ethics approvals for clinical trials and protocol amendments, managing preparation and submission of required documentation.

Additional Responsibilities

  • Approve and monitor study monitoring plans and related interventions.
  • Review and approve all study-related materials and operational guides.
  • Oversee site documentation and ensure compliance with local and international regulatory requirements.
  • Organize and lead investigator meetings, ensuring effective communication with investigators and partners throughout the study lifecycle.
  • Supervise site files and conduct regular quality control checks to ensure GCP compliance.
  • Ensure adherence to company SOPs, Good Clinical Practice, and all applicable regulations in all assigned clinical trials.
  • Support Business Unit initiatives, including process improvement and ad hoc projects.
  • Qualifications

    Our ideal candidate possesses strong leadership skills, excellent communication abilities, and a deep understanding of clinical operations. If you are passionate about advancing healthcare through innovative research, we encourage you to apply for this exciting opportunity.

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    Buen Salario Leader • Madrid, Kingdom Of Spain, España

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