Associate Director, Clinical Development Trial Lead (CDTL)
 

• Location: Stamford, CT (Onsite/Hybrid options)
  

• Pay Rate: $100.00 – $104.00/hour W-2
  

• Assignment Duration: 12–18 months (Potential for permanent conversion for local candidates)
  

• Employment Type: Full-time W-2 Contract (Kelly consultant assigned to a direct sponsor client)

Position Summary
Kelly Science and Clinical is seeking an Associate Director, Clinical Development Trial Lead (CDTL) with a strong background in Oncology (early and/or late phase) to manage the operational and technical execution of complex clinical trials. The Associate Director, CDTL independently leads cross-functional study teams and holds global/regional accountability for delivering clinical milestones on time, within scope, and on budget. This role requires exceptional independent leadership, strategic risk management, and the ability to influence cross-functional matrix teams, vendors, and business partners. This is a full-time, M-F contract opportunity embedded directly with a premier sponsor client.

Key Responsibilities
Project Management & Global/Regional Operations

• Trial Execution: Utilize advanced project management tools and methodologies to scope, track, and execute local, regional, and global clinical trials.
  

• Timeline & Enrollment: Develop and track global trial enrollment plans; align inputs across geographies and functions from country allocation through Last Patient Entered Treatment (LPET).
  

• Budget & Risk Management: Monitor trial-level budgets (grants, non-grants, and financial assumptions); proactively identify, assess, and mitigate trial-level risks.
  

• Vendor & CRO Oversight: Serve as the primary clinical development point of contact for fully or partially outsourced trial execution; manage Third-Party Organization (TPO) qualification, selection, and milestone delivery.
  

• Cross-Functional Leadership: Drive solutions across the broader Therapeutic Area/Molecule level, attending critical chain network builds and providing strategic input.

Process Leadership & Inspection Readiness

• Single Point of Accountability: Own the Trial Master File (TMF) for assigned trials, ensuring functional record owners keep documentation current and continuously inspection-ready.
  

• Quality & Compliance: Apply global/regional regulations, Good Clinical Practice (GCP), and sponsor standards. Independently detect and resolve quality issues, collaborating with Medical Quality, Legal, and Compliance as needed.
  

• Process Improvement: Act as a Subject Matter Expert (SME) to develop and roll out new tools, methodologies, and continuous improvement activities based on regulatory or industry trends.

Scientific Consultation

• Document & Regulatory Support: Leverage scientific and regulatory knowledge to prepare technical documentation, prepare for regulatory agency meetings, and draft responses to TPO or affiliate inquiries.
  

• Study Design Input: Combine scientific, regional, and operational expertise to positively impact clinical trial design, feasibility, and implementation.

Qualifications

• Education: Bachelor’s degree required; a scientific or health-related field is highly preferred.
  

• Experience: Minimum of 5 years leading clinical trials with deep working knowledge of the clinical research process. (10+ years of overall industry experience within clinical research/life sciences preferred).
  

  • Required: Direct experience managing Oncology trials (early and/or late phases).
    

  
  

• Leadership Skills: Demonstrated ability to influence without authority, navigate complex/ambiguous situations, and manage cross-cultural global teams.
  

• Technical Expertise: Applied knowledge of project management methodologies and proficiency with industry tools (e.g., Veeva, MS Project, Excel, PowerBI, Critical Chain).
  

• Compliance Knowledge: Strong familiarity with local/regional country requirements and international GCP guidelines.
  

• Travel: Ability to travel periodically to scientific or regional meetings as required.