Associate Director – Clinical Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure that clinical-stage programs achieve their objectives within the established timelines, budget constraints, and quality standards.

• Plan and oversee clinical studies from initiation to execution, reporting, and finalization.

• Lead and coordinate the integration of activities among internal teams, development partners, and CRO project teams.

• Supervise clinical trials from their inception through to completion.

• Provide leadership and direct management to the clinical operations team.

• Develop global recruitment strategies for subjects/patients and maintain communication with principal investigators of the studies.

• Manage CRO/vendor relationships and establish key performance indicators.

• Formulate contingency and risk management strategies.

• Assist clinical project managers across various programs.

• Prepare budgets, study timelines, forecasts, and conduct variance analyses.

• Monitor the progress of clinical studies through effective communication with CROs and investigator sites.

• Coordinate cross-functional teams to ensure optimal execution of clinical trials.

• Review and finalize study-related plans and systems.

• Participate in the design of Case Report Forms and conduct user acceptance testing.

• Contribute to the development of protocols and informed consent documents from an operational feasibility viewpoint.

• Oversee study budgets, contracts, payments, and accruals.

• Maintain the Trial Master File and ensure readiness for inspections.

• Support audit and inspection processes.

• Collaborate with regulatory and medical teams regarding safety management and monitoring procedures.

• Initiate processes for clinical change control.

• Contribute to the development of SOPs and improvements in departmental infrastructure.

⛳️ Requirements

• Proven experience and ability to lead and manage clinical trials through their entire lifecycle.

• Expertise in operational planning and execution for clinical studies.

• Familiarity with GCP and ICH guidelines.

• Understanding of regulatory requirements and company SOPs.

• Experience in managing multidisciplinary internal and external teams.

• Skills in identifying, procuring, selecting, and operationally managing CROs/vendors.

• Experience in developing and managing key performance indicators.

• Background in Case Report Form design and user acceptance testing.

• Proficiency in developing contingency and risk management plans.

• Experience in preparing budgets, study timelines, and forecasts.

• Knowledge of overseeing investigator and vendor contracts, budgets, and payments.

• Experience with the setup, maintenance, closure, and audit readiness of the Trial Master File.

• Background in supporting audits and inspections.

• Experience with clinical change control processes.

• Proven ability to provide line management, mentoring, and staff development.

• Capability to collaborate effectively with Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory, Program Management, CROs, and other stakeholders.

• Strong communication, collaboration, adaptability, ethical conduct, and dedication to continuous learning.

🏝️ Benefits

• Performance-based bonuses awarded annually.

• Equity-based incentive programs available.

• Generous vacation policy.

• Paid wellness days provided.

• Support for ongoing learning and development opportunities.

• Flexible hybrid and remote work options.