Associate Director, Clinical Development Trial Lead; CDTL; W

Associate Director, Clinical Development Trial Lead (CDTL) (W-2 Contract)

Employment Type:

Contract (FTE W-2 through Arc Technologies Group)

Client: A leading global pharmaceutical company (Fortune 100)

Location:

Stamford, CT (On-site)

Duration: 6-18 Months; 6 month initial term

• Project Management, and Regional Operational Knowledge:
  • Broader responsibilities at Therapeutic Area / Molecule / Indication level (e.g. attending critical chain network builds and providing input on strategy).
  • Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials.
  • Scope – Understand the scope of work required to complete the clinical trial successfully, monitor status and adjust as needed per change control process.
  • Timeline – Develop and track global trial enrollment plan, integrating inputs across functions and geographies. Provide consultation and guidance to CDTLs on integrated plans.
  • Risk – Assess, identify and monitor trial-level risks.
  • Budget – Understand cross‑functional, trial-level budget components. Create and monitor budget grants and non‑grants and assumptions using financial tracking tools. Act as point of contact for other CDTLs on budget items.
  • Lead, influence and project manage large, complex studies and multiple smaller studies.
  • Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training and Affiliate Study Training.
  • Independently drive and influence local, regional and global cross‑functional study team throughout study implementation, execution and closure, empowering them to meet deliverables and proactively manage issues, contingency planning and resolution.
  • Be accountable for enrollment strategy and execution from country allocation through Last Patient Entered Treatment.
  • Partner with Regional Operations to achieve regional enrollment goals.
  • Anticipate and resolve complex and key technical operational or business problems with cross‑functional study team with little need for direct management support; evaluate and identify issues that require escalation.
  • Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
  • Use expertise to make timely decisions for ambiguous and complex situations.
  • Manage TPO qualification, selection and oversight.
  • Serve as CRO clinical development point of contact for outsourced trial execution, ensuring delivery of project milestones.
• Clinical Trial Process Leadership and Expertise:
  • Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise to influence study design and program-level decisions considering regional needs.
  • Recognize interrelatedness of cross‑functional activities and understand impact of project decisions on overall trial.
  • Coordinate and facilitate obtaining regional input to provide study teams.
  • Single point of accountability for Trial Master File for assigned trials, keeping file current and inspection ready.
  • Ensure inspection readiness and timely documentation of deviations, create story boards or issue summary documents for high‑risk areas.
  • Network and apply expertise to anticipate trial and regional issues, identify process breakdowns, analyze situations and propose innovative approaches to mitigate risks.
  • Coach peers and new CDTLs, cross‑functional team members and TPOs on CT process and regional specifics.
  • Lead process improvement activities; act as CDTL SME resource to peers and in development and rollout of new tools, processes or methodologies.
  • Report, manage and interpret information for clinical trials, driving regional operational processes and methodologies.
  • Apply knowledge of global/regional regulations, GCP and client standards. Liaise with affiliates to understand local regulatory requirements.
  • Independently detect and resolve quality issues, escalating to functional leadership or consulting other functions to find best solution.
• Scientific Expertise:
  • Prepare and provide technical consultation for clinical and regulatory documents.
  • Prepare for meetings with regulatory agencies and draft responses to…