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Clinical Operations Associate Director

1 month ago

Étreux, Hauts-de-France, United States Tech Observer Full time

Tech Observer is seeking a seasoned Associate Director of Clinical Operations to lead the planning, execution, and management of complex clinical programs. This role requires strong leadership skills, strategic thinking, and effective collaboration with cross-functional teams to ensure compliance with budgets, scopes, and timelines.

Key Responsibilities:

  • Lead study teams and provide strategic guidance for clinical programs.
  • Collaborate with cross-functional leads to develop initial study budgets and act as the main liaison with finance and leadership throughout the project lifecycle.
  • Create and maintain global study timelines and budgets, coordinating efforts across all internal functions, vendors, and CROs while identifying and escalating significant risks.
  • Serve as the primary operations contact for internal and external stakeholders, managing escalations from investigators and sites.
  • Facilitate the selection of CROs, consultants, and vendors by identifying potential partners and crafting requests for proposals.
  • Oversee CRO and vendor activities, ensuring coordinated efforts to meet key milestones and deliver high-quality results in study management.
  • Develop study-specific operational plans in collaboration with vendors, clarifying roles, responsibilities, and communication channels.
  • Contribute to the creation of various documents and plans from other departments, such as data management and safety plans.
  • Track and report on the progress of clinical trials, including enrollment metrics, performance indicators, milestones, and budget compliance.
  • Continuously assess risks to study performance, implementing proactive mitigation strategies as needed.
  • Organize and engage in meetings, including Study Team, Investigator, and Scientific discussions.
  • Review and contribute to important study documents, including specifications, manuals, training materials, and communication strategies.
  • Assist in drafting protocols, clinical study reports, and regulatory documents.
  • Conduct quality reviews of study operations and prepare for internal and external audits.
  • Regularly assess operational efficiency and communication, making necessary adjustments to enhance team performance.
  • Review and update standard operating procedures (SOPs) for Clinical Operations, contributing to departmental improvement efforts.
  • Directly or indirectly manage CTAs and junior clinical operations staff.
  • Support project team resource management and strategic planning.
  • Undertake additional duties as assigned.

Requirements:

  • Education: Bachelor's degree in a science-related field or nursing.
  • Experience: Minimum of 10 years in clinical research, including at least 6 years in trial management (sponsor or CRO), with a minimum of 5 years in vendor management. Experience in oncology, neurology, or radiopharmaceuticals is essential.

Preferred Qualifications:

  • Master's degree (MBA, MS, or MPH) or PMP certification.
  • Experience in monitoring oversight or direct monitoring is a plus.

Other Requirements:

  • Strong interpersonal and analytical skills with effective influencing and negotiation abilities.
  • Excellent problem-solving and decision-making skills.
  • In-depth knowledge of clinical trial methodology, drug development processes, ICH-GCP guidelines, and relevant regulatory standards.
  • Experience in managing clinical programs and operations for clinical trials.
  • Highly organized, detail-oriented, and strong written and verbal communication skills.
  • Proficient in MS Office applications.