Associate Director, Clinical Site Services - TD2

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 oversees the Site Services department providing oversight of day-to-day responsibilities associated with site identification, site selection, study start up and patient enrollment management of clinical projects. This position reports to the head of Clinical Services.

Essential Functions:

• Directly manage development and performance of the Site Services and patient engagement department (e.g., Site Engagement, Study Start-up, Patient Engagement Clinical Trial Management).
• Ensure department compliance with FDA and ICH GCP regulations, Sponsor guidelines and all SOPs (internal and external) for clinical projects.
• Monitor and coordinate the efforts of the team to ensure project milestones are met.
• Manage third parties (e.g., sites, vendors, consultants) and vendors assigned to projects including ensuring budgets are accurate and contracted services stay within contracted scope.
• Develop training materials and oversee training of personnel, ensuring they are fully trained and follow applicable Controlled Documents, regulations, and internal processes.
• Manage team project assignments and Site Services resources to ensure full coverage for all clinical trial work without unnecessary interruptions or team disruptions.
• Develop and coach employees during routine one-on-one meetings (e.g., every two weeks), work with them on career planning and skill building activities, and maintain accurate job descriptions.
• Proactively address employee performance with clear and thorough documentation of issues, coaching discussions, issuance of corrective performance planning, and inclusion of HR input and guidance.
• Quickly address and resolve trial and team quality issues, including CAPA investigations, with guidance from Quality Assurance.
• Thoroughly understand trial contracts and budgets for Site Services, with proactive involvement of TD2 Business Operations and Finance teams. Ensure accurate project scope and change order process throughout trial conduct.
• Drive monthly revenue recognition activities by staying current on project management trial activities, then working with direct reports, Project Manager, and Project Accountants to ensure revenue recognition is completed accurately/on time.
• Participate in monthly utilization preparation and review by accurately reporting productivity metrics and completing utilization trackers.
• Ensure direct reports stay within project scope by ensuring they accurately report, and document completed work. Review and correct time entries within set weekly timeframes.
• Develop, compile and report monthly department metrics and Key Performance Indicators (KPIs) for department tracking and decision-making purposes.
• Guide the Site Services department in reviewing clinical documents such as protocols, protocol amendments, informed consent forms, regulatory document tracker, essential document checklist and other plans to ensure trial specifics are implemented correctly.
• Monitor site identification and selection, study start-up and enrollment updates.
• Join project meetings to interact with Sponsors and ensure projects are on track. Assist with risk analysis, triage, and problem solving as trials progress.
• Maintain accuracy and participating in the development and implementation of clinical policies and procedures, including working guidelines, SOPs, and informal processes related to Site Services activities.
• Manage electronic systems used in conjunction with site identification, site selection, study-start up, and site management (e.g., CTMS, Citeline, Site Database, SmartSheet).
• Develop annual department and individual goals and objectives.
• Collaborate with Business Operations and Business Development departments on proposal and bid defense opportunities.
• Represent TD2 during quality audits with specific focus on project support activities.
• Effectively communicate with senior management on strategies to grow the Site Services business at TD2, including forecasting and predicting future department needs regarding resources, technology, and training.
• Prepare and forecast future team and department needs through annual budget and staff planning.
• Collaborate with other TD2 departments in a matrix management environment, limiting siloes and miscommunications through proactive identification of activities and issues that cross teams.
• Immediately report any clinical trial fraud, misconduct, or serious breaches to TD2 senior management.
• Perform other responsibilities as assigned.

Job Requirements:

• Bachelor’s degree in a life sciences or health related field; master’s degree preferred.
• At least 10 years of job-related experience, including both management and clinical research experience.
• A good working knowledge of MS Office products including Word, Excel, PowerPoint, and SharePoint
• Experience in oncology is essential.

Required Specialized/Technical Skills:

• Strong employee supervisory and department management skills including mentoring, training, and leading the work of others.
• Prior experience with multi-center studies and clinical research sites with a deep understanding of all aspects of clinical research operations including clinical trial design, study implementation and conduct and patient recruitment and enrollment.
• Demonstrated skill with establishing and documenting standard processes by which project tracking is collected, updated, and reported to the project team.
• Advanced financial acumen, including budgeting, metric tracking, and revenue recognition.
• Detailed training in all aspects of clinical trial research with advanced knowledge of GCP and ICH guidelines and FDA regulations.
• Understanding of the principles of Phase 1-4 clinical research.
• Ability to lead and manage employees working in a matrix reporting environment.
• Oncology background.
• Effective oral/written communication, problem-solving, and critical thinking skills.
• Strategic thinking.
• Able to work collaboratively 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.

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