Associate Director, Clinical Development Trial Lead (CDTL)
Location: Indianapolis IN (Onsite/Hybrid potential)
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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
