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Job Description
AD of Clinical Development Trial Lead Apply Now Applied To save a job sign in or get started
Job ID:
10272827 Posted today Back Stamford, CT, US Scientific Bachelors Degree Full Time, Temporary 100.00 - 104.00 w-2 hourly Manager (Manager/Supervisor) On-site Biotechnology/Pharmaceuticals First Shift (Day) Stamford, CT, US 100.00 - 104.00 w-2 hourly Manager (Manager/Supervisor) Full Time, Temporary Biotechnology/Pharmaceuticals On-site Scientific Bachelors Degree First Shift (Day) Apply Now Applied Job details 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.
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.
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. 10272827 Share this job Copied url To save a job sign in or get started To apply for this job email your details to I want more jobs like this in my inbox.
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