Clinical Trial Manager overseeing clinical studies with a focus on Atopic Dermatitis. Ensuring compliance with ICH GCP and delivering results within contractual timelines.
About the role
- Clinical Research Scientist developing innovative breast cancer therapies at Lilly. Collaborating with cross-functional partners in clinical trial design and execution.
Responsibilities
- Contribute to the development and execution of clinical strategies for breast cancer programs.
- Maintain a focus on accelerating timelines while ensuring quality.
- Demonstrate compliance with procedures and be accountable for compliance of team members.
- Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
- Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
- Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
- Collaborate with Global Patient Safety on risk management planning.
- Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
- Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
- Participate in data analysis, scientific dissemination, and preparation of final study reports.
- Analyze and contextualize clinical data to support decision-making and portfolio strategy.
- Contribute to strategic planning and innovation through cross-functional working groups.
- Support planning and execution of symposia, advisory boards, and other external engagements.
- Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
- Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.
Requirements
- PhD with 3+ years of industry experience OR BS Degree or equivalent experience in Health-related field with 10+ years’ industry experience
- 3+ years of clinical research scientist experience/clinical trial experience
- Direct Line Leadership experience
- Breast cancer disease state knowledge/experience
- An advanced health/medical/scientific graduate degree such as PharmD, PhD, MSN with advanced clinical specialty
- Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
- Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills
- Demonstrated ability to influence others
Benefits
- Medical, dental, vision, and prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care)
- Life insurance and death benefits
- Vacation benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
- Company-sponsored 401(k)
- Pension
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