Role Overview
We are seeking a Clinical Trial Manager to support or lead specific activities for planning, setup, and execution of assigned drug trials, which may include:
- Pre/post-POC interventional drug trials
- Clinical Pharmacology normal healthy volunteer clinical trials
- Pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional)
This position reports to the Clinical Trial Lead and Operations Lead, working collaboratively with cross-functional team members and vendors to ensure the effective execution of trials in compliance with SOPs and quality standards.
Essential Job Responsibilities
- Manage day-to-day operations of assigned trials to ensure completion according to project team goals and compliance with GCP/ICH guidelines.
- Lead or support cross-functional trial teams, including vendors, ensuring accurate and up-to-date trial information in tracking systems.
- Proactively identify and resolve issues that arise during trial conduct, managing escalations as necessary.
- Participate in or lead the development of core trial documents, trial plans, and system setups to ensure operational excellence.
- Assess and select trial vendors, managing interactions and escalations effectively.
- Conduct feasibility assessments and select countries/sites for trial conduct.
- Facilitate site engagement and communication with investigators to support trial milestones.
- Oversee timely data cleaning, data analysis, and availability of topline results; participate in data reviews and statistical analysis plans.
- Coordinate investigator and site monitor training and operational/therapeutic area training for trial team members.
- Manage clinical trial budgets and associated vendor contracts, ensuring quality and completeness of Trial Master Files (TMF).
- Participate in inspection readiness activities and evaluate patient-focused strategies for assigned trials.
Qualifications
Required
- BA/BS degree with at least 3 years of clinical trial experience, or direct equivalent experience; advanced degree (MS/PhD/PharmD) with at least 2 years of clinical trial experience.
- Experience in Early Development Oncology.
- Strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Understanding of protocol and clinical drug development processes, clinical trial design, and management.
- Excellent project management skills and trial leadership ability.
- Strong interpersonal, written, and verbal communication skills.
- Fluent in English; moderate travel (~25%) required.
Preferred
- Advanced Degree (MS/PhD/PharmD).
Benefits
- Medical, Dental, and Vision Insurance
- Generous Paid Time Off, including vacation, sick time, and national holidays
- 401(k) match and annual company contribution
- Company-paid life insurance
- Annual corporate bonus and quarterly sales incentive for eligible positions
- Long-term incentive plan for eligible positions
- Referral bonus program
APPLICATION INSTRUCTION
Astellas is committed to equality of opportunity in all aspects of employment. We welcome diversity and encourage individuals from all backgrounds to apply.