Associate Director Clinical Operations

1 month ago

boston, United States Tech Observer Full time

Tech Observer is hiring on Multiple roles in Clinical Operations: Director and Associate Director Clinical Operations for one its esteemed client.


Hybrid Role : 2-3 days work from office


Key Responsibilities/ Essential Functions


The Associate Director of Clinical Operations is responsible for leading the planning, execution, and management of intricate clinical programs while ensuring compliance with budgets, scopes, and timelines. This role entails overseeing multiple clinical trials and fostering effective collaboration with CROs, vendors, and internal teams to achieve results. Key duties include monitoring timelines, ensuring patient safety, meeting contractual obligations, and upholding data integrity.


This position demands strong departmental leadership and the ability to make strategic recommendations regarding clinical operations deliverables, budgets, and resource management. The ideal candidate will showcase independence, effective communication skills, strategic thinking, team motivation, and a drive for success.


Key Responsibilities:

  • Lead study teams and provide strategic guidance for clinical programs.
  • Collaborate with cross-functional leads to develop initial study budgets, acting 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.

Basic Qualifications:

  • 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.

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