What are the responsibilities and job description for the Associate Director, Clinical Development Trial Lead (CDTL) position at System One?
Job Title: Associate Director, Clinical Development Trial Lead
Location: Indianapolis, IN
Type: Contract - 1 year
Work Model: Onsite – onsite
Joulé is partnering with a leading pharmaceutical organization seeking an experienced Associate Director, Clinical Development Trial Lead to drive the execution of complex global oncology clinical trials. This highly visible leadership role offers the opportunity to oversee study strategy, enrollment, budgets, CRO partnerships, and cross-functional teams while influencing clinical development decisions on a global scale.
Responsibilities
- Independently lead the cross-functional study team in the development and execution of complex clinical trials and ensure delivery of clinical milestones on trial(s) with quality, on time, and within scope and budget.
- Demonstrate independent leadership and influence when working with study teams, management, and business partners, and proactively identify issues and resolve them.
- 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 inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial.
- Coordinate and facilitate obtaining regional input to provide to the study teams.
- Act as single point of accountability for the Trial Master File for assigned trials, working closely with functional record owners to ensure the file is current and inspection ready at all times.
- Ensure inspection readiness of respective clinical trial(s), including timely documentation of deviations and creation of story boards or issue summary documents (e.g. for high-risk areas/hot topics).
- Report, manage, and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools.
- Drive regional clinical operational processes and methodologies used.
Requirements
- Bachelor's degree (scientific or health-related field preferred)
- 5 years clinical research experience or relevant experience in a scientific or health-related field
- Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process
- Experience with oncology (early & late phase clinical trials)
- Prior clinical trial site-level or affiliate experience
- Prior experience with local/country regional requirements
- Need to travel periodically to scientific/regional meetings
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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Ref: #568-Clinical