Associate Director – Clinical Operations

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

📋 Description

• Oversee the daily execution of clinical trials for designated studies, encompassing site activation, enrollment, monitoring, and closeout.

• Act as the primary clinical operations leader and main liaison for CROs, vendors, and clinical sites.

• Facilitate cross-functional trial team meetings to ensure alignment on deliverables, timelines, and risk management strategies.

• Provide guidance and mentorship to Clinical Trial Managers.

• Manage relationships with CROs and vendors, ensuring delivery of services, tracking performance metrics, and resolving issues.

• Promote vendor integration across CROs, central laboratories, and specialty service providers.

• Monitor and forecast study budgets, report any variances, and review vendor invoices.

• Guarantee the completeness and inspection-readiness of the TMF/eTMF.

• Create and maintain study manuals, informed consent forms (ICFs), tracking tools, and monitoring plans.

• Ensure compliance with regulatory standards and Good Clinical Practice (GCP); lead preparations for audits and inspections.

• Review clinical trial data listings and coordinate data analysis to address deviations, trends, discrepancies, and queries.

• Supervise lab sample tracking, shipment, reconciliation, and vendor coordination.

• Organize the availability of both clinical and non-clinical trial supplies.

• Spearhead the development and implementation of standard operating procedures (SOPs) and contribute to process improvements.

• Maintain professional relationships with investigators and trial site managers.

• Represent clinical operations in cross-functional meetings and governance discussions.

• Contribute to feasibility assessments and the development of protocols.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related discipline.

• Minimum of 8–10 years of experience in Clinical Operations, managing clinical trials within the biopharma sector, including experience with global trials.

• Capable of independently leading clinical trials from initiation to closure, including financial tracking, reporting, and vendor oversight.

• Experience in providing direction or informal management to Clinical Trial Managers or equivalent clinical operations personnel; formal management experience is a plus.

• Strong knowledge of CRO/vendor oversight and the clinical development lifecycle.

• Experience managing complex, multi-vendor programs.

• Proven experience with cross-functional leadership and clinical teams, including data review and study reporting activities.

• Preferred early-phase oncology experience.

• Prior experience in a lean or startup environment is highly desirable.

• Required experience in maintaining a submission-ready electronic Trial Master File (eTMF).

• Background in Quality Assurance, SOP and study plan writing, and audit/inspection readiness.

• Robust understanding of ICH-GCP and global regulatory requirements.

• Proficient in clinical trial systems (e.g., EDC, CTMS, eTMF), timeline management tools (e.g., Smartsheet), and the Microsoft Office Suite.

• Exceptional project management, communication, and problem-solving abilities; skilled at leading and influencing within a cross-functional environment.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.

• Flexible work arrangements and a supportive work environment.

• Generous vacation and paid time off policies.