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Associate Director, Clinical Development Trial Lead (CDTL)

L7

allstem connectionsLexington, KYyesterday

$104.50/hour

Occupations

Clinical Research CoordinatorsNatural Sciences ManagersMedical and Health Services Managers

Industries

Research and Development in the Physical, Engineering, and Life SciencesResearch and Development in BiotechnologyOther Scientific and Technical Consulting Services
AllSTEM Connections is seeking an Associate Director, Clinical Development Trial Lead (CDTL) to work remotely supporting EST. Can also work onsite in either Indianapolis, IN or Stamford, CT.This is a 12-month contract position. Possible extension/temp-to-hire. Hourly rate is up to $104.50/hour. M-F, 8AM - 5PM.Associate Director, Clinical Development Trial Lead (CDTL) – Late PhaseSUMMARY:The Associate Director, Clinical Development Trial Lead (CDTL), independently leads cross-functional study teams in the development and execution of complex, late-phase clinical trials. This individual is accountable for delivering clinical milestones on time, within scope and budget, and in accordance with quality standards across regional and global operations. The CDTL provides strategic and operational leadership throughout the clinical trial lifecycle, proactively identifying and resolving risks, influencing cross-functional decisions, and ensuring effective collaboration among internal teams, affiliates, external partners, and third-party organizations (TPOs).
RESPONSIBILITIES: Clinical Trial Leadership & Execution
Independently lead, influence, and manage large, complex clinical trials and/or multiple smaller studies throughout implementation, execution, and closeout. Drive cross-functional study teams toward clinical trial deliverables, proactively managing issues, developing contingency plans, and resolving operational challenges. Maintain accountability for trial-level, regional, program-level, and molecule-level enrollment strategy and execution, from country allocation through Last Patient Entered Treatment (LPET).Partner with Regional Operations to achieve enrollment objectives. Coordinate and participate in Investigator Study-Specific Training (ISST) and Affiliate Study Training (AST).Provide input into broader therapeutic area, molecule, and indication-level strategies, including participation in critical chain network development.
Project Management, Budget & Risk Management: Apply project management methodologies, processes, and tools to establish and manage clinical trial scope, timelines, deliverables, and resources. Develop and monitor global enrollment plans by integrating input and gaining alignment across functions and geographies. Assess, identify, and monitor trial-level risks, proactively implementing mitigation strategies and escalating issues when appropriate. Understand cross-functional trial budgets, including grant and non-grant components, and monitor budget assumptions, expenditures, and changes using financial tracking tools. Partner with appropriate business stakeholders to address budget status, changes, and financial considerations. Provide consultation and guidance to other CDTLs on integrated study plans and budget-related matters as needed.
Regional Operations, Compliance & Quality Oversight: Apply knowledge of global and regional clinical trial operating models, coordinating with affiliates and regional teams to incorporate local requirements into study planning and execution. Ensure compliance with applicable regulations, Good Clinical Practice (GCP), and company operating standards. Serve as the single point of accountability for the Trial Master File (TMF) for assigned trials, partnering with functional record owners to maintain a complete, current, and inspection-ready file. Ensure inspection readiness and timely documentation of deviations, including preparation of storyboards and issue summary documents for high-risk areas. Independently identify and resolve quality and operational issues, engaging functional leadership and appropriate partners, including Medical Quality, Legal, and Compliance, when escalation is necessary. Anticipate and resolve complex operational and business challenges involving vendors, affiliates, regional teams, global stakeholders, and other business partners.
External Partner & Process Leadership: Manage third-party organization (TPO) qualification, selection, and oversight processes. Serve as the clinical development point of contact for Contract Research Organizations (CROs) supporting outsourced and fully outsourced clinical trials, ensuring delivery of project milestones. Identify and lead continuous improvement initiatives based on industry trends, regulatory developments, emerging technologies, and operational learnings. Contribute to the development and implementation of new tools, processes, and methodologies that improve clinical trial execution. Serve as a subject matter expert (SME) and resource to peers and cross-functional colleagues, coaching other CDTLs, new team members, and TPOs on clinical trial processes and regional requirements.
Scientific & Therapeutic Area Expertise: Apply scientific, clinical development, and regulatory knowledge to influence clinical trial design, feasibility, and implementation. Provide technical consultation and support in the preparation of clinical and regulatory documents. Prepare for regulatory agency meetings and assist with drafting responses to regulatory agency questions. Serve as a therapeutic area and/or disease-state subject matter expert, providing scientific guidance and supporting the clinical needs of the business.
QUALIFICATIONS: Bachelor's degree in a scientific or health-related field preferred. Minimum of 5 years of clinical research experience or relevant experience in a scientific or health-related field. Strong working knowledge of the clinical research process and clinical trial execution. Demonstrated experience leading cross-functional teams and managing complex clinical trial activities. Strong understanding of clinical trial operations, project management, and regional/global clinical research requirements. Demonstrated ability to independently identify, assess, and resolve complex operational issues. Strong analytical, problem-solving, critical-thinking, communication, organizational, and self-management skills. Ability to influence without authority and establish effective working relationships across cross-functional teams and external partners.
PREFERRED QUALIFICATIONS: Experience supporting oncology clinical trials, including early- and late-phase studies. Prior clinical trial site-level or affiliate experience. Experience working with local and country-specific regulatory and operational requirements. Applied knowledge of project management methodologies, processes, and tools. Demonstrated ability to lead and collaborate effectively with global, cross-cultural teams and third-party organizations. Recognized leadership ability, including experience coaching and developing colleagues. Ability to navigate ambiguity, manage competing priorities, and lead teams through organizational change. Proficiency with project management and clinical trial tools, including Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, and Power BI.
ADDITIONAL INFORMATION: Periodic travel may be required for scientific and regional meetings.
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Level

ManagerL7

Salary

$104.50/hour

Location

Lexington, KY

Occupation

Clinical Research Coordinators

Industry

Research and Development in the Physical, Engineering, and Life Sciences

Posted

yesterday

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