We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients. Position Summary: This position is responsible to work closely with the VP of Clinical Operations on planning, tactical implementation, and reporting of activities for clinical research trial activities performed in the Clinical Services division (e.g., Site Services, Project Management & Project Services, Clinical Monitoring). This position oversees operational clinical functions from trial start-up through project and site management, including support organizations and clinical consultants to ensure the successful, cost effective, and timely execution of clinical trials. Essential Functions: • Directly oversee and provide strategic management for the TD2 Clinical Services team to ensure alignment of activities with cost effective and timely execution of clinical trials. • Ensure department compliance with FDA, ICH GCP, and international regulations, Sponsor guidelines and all Controlled Documents (internal and external) for all clinical projects with ability to incorporate updated regulatory guidance into current practices. • Review trial contracts and provide input to ensure accurate scope and budgeting of clinical operations activities, and oversee management of trials to identify project objective, potential obstacles and propose innovative solutions. • Work with Project Management team leader on trial governance activities with Sponsors to ensure projects are on track. Assist with risk analysis, triage, and problem solving as trials progress. • Report meaningful department KPIs and metrics to senior management, making improvements as needed to demonstrate continuous process improvement. • Provide mentoring, leadership, guidance, clinical trial management expertise and direction for staff within the Clinical Services division and support new candidate recruitment to support department growth. • Manage direct report performance to full regulatory and company expectations by providing performance feedback, providing career development opportunities, and working with HR to administer disciplinary action when required. • Oversee of the development and revision of Controlled documents, departmental policies, and training documents. • Communicate with senior management regarding the progress of ongoing clinical projects. • Work with Clinical Trainer to establish and implement formal training processes for employees and consultants in the Clinical Services department. • Oversee and ensure team participation in all scheduled audits (e.g., Sponsor-conducted GCP audits, FDA audits) and TD2’s annual internal audits as it pertains to the Clinical Services department. • Aid the Project Management team in sourcing and managing clinical vendors and consultants. • Lead budget development activities with Business Operations and oversee department resource planning. • Work closely with the leader of the Project Management team to track monthly department and project financials and work closely with the head of Clinical Development and the finance department to ensure accurate reporting. Job Requirements: • Bachelor’s degree in a health science or related field with Master’s degree or MBA preferred. • At least 10 years of job-related experience, including knowledge of clinical trial project management, clinical monitoring, and site services/site management. • Expert knowledge in drug development with experience in oncology as a therapeutic area. Required Specialized/Technical Skills: • Knowledge of GCP, ICH guidelines and FDA regulations. • Understanding of the principles of clinical trial management. • Ability to effectively lead and manage a Clinical Services team. • Prior experience with managing large, multi-center trials with a deep understanding of all aspects of clinical operations including clinical trial design, trial implementation, CRA/site management, data management. • Oncology therapeutic experience. • Strong working knowledge of MS Office products including Word, Excel, PowerPoint, SharePoint, and Teams. • Excellent communication and problem-solving skills in a matrix team environment. • Strategic planning skills related to department growth, budgeting, and process improvement . • Ability to work under tight timelines. TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression. #LI-TD2 #LI-Remote