Sr. CTM/Associate Director, Clinical Operations

Role Summary

The Sr. CTM/Associate Director, Clinical Operations will be responsible for independently managing operational aspects of assigned clinical trials, with a focus on early-phase oncology studies. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution. The ideal candidate will bring an in-depth understanding of managing early phase oncology trials at a sponsor biotech.

Responsibilities

• Lead the planning, initiation, execution, and close-out of complex Phase I oncology trials. Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations.
• Manage and oversee external partners including CROs, central labs, biometrics, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards.
• Manage, mentor, and support direct reports, fostering professional development and team performance.
• Participate in site selection, feasibility assessments, and initiation visits. Build strong relationships with investigators and site staff to support efficient enrollment and high-quality data collection.
• Oversee the development and review of essential study documents such as protocols, informed consent forms, case report forms (CRFs), monitoring plans, and study manuals.
• Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO monitors and ensure appropriate sponsor oversight is documented.
• Conduct ongoing data reviews and support data cleaning activities. Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF).
• Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders.
• Work closely with internal stakeholders including Clinical Development, Regulatory Affairs, Medical Affairs, and CMC to ensure alignment and smooth execution of clinical programs.
• Provide guidance and mentorship to junior team members and cross-functional colleagues. Share best practices and contribute to continuous process improvement.
• Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings.
• Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance.
• Willingness to travel up to 15% for site visits, vendor meetings, and conferences.
• Other activities as assigned

Qualifications

• BA/BS in related scientific field with a minimum of 8-10 years (Sr. CTM) OR 10–12 years (Associate Director) of experience in clinical research, with at least 6 years in clinical trial management.
• Demonstrated experience managing early-phase oncology trials, particularly in solid tumors and immunotherapy/biologics.
• Proven track record of leading trials from start-up through close-out, including protocol development, site initiation, vendor management, and data review.
• Strong knowledge of ICH GCP, FDA regulations, and global clinical research guidelines.
• Proficiency in MS Office and clinical trial systems (e.g., CTMS, eTMF, EDC).
• Ability to interpret and analyze clinical data and metrics.
• Excellent communication, leadership, and interpersonal skills.
• Strong organizational and time management abilities.
• High level of accountability, adaptability, and attention to detail.
• Ability to work independently and collaboratively in a fast-paced, matrixed environment.
• Ability to travel up to 15%.

Education

• Not specified beyond the BA/BS requirement; relevant advanced degrees or certifications in clinical research or related fields are a plus.