Description
Responsibilities:- Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
- Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
- Develop study budget and timelines
- Prepare regulatory documents and submissions
- Execute project specific training for internal and external staff
- Maintain Trial Master File
- Manage Investigational Product (IP)
- Manage safety reporting
- Procure and manage contracts with CROs, study vendors and investigative sites
- Provide oversight of CROs, independent field monitors and other clinical vendors
- Review monitoring trip reports and track resolution of all action items
- Co-monitor at investigative sites to evaluate study site and field monitor performance
- Collaborate with medical experts, clinical study sites, and clinical study vendors
- Performs in-house review of clinical database listings for completeness and accuracy
- Develops clinical study reports
Qualifications:
- Excellent verbal and written communication skills
- Attention to detail
- Able to organize, manage and set priorities for multiple tasks
- Strong leadership skills, self-motivated
- Able to collaborate effectively with the study team, cross-functional team members, and external partners
- Knowledge of ICH/GCP and FDA regulations
- Proficiency in MS Word, Excel and Powerpoint
- Able and willing to travel approximately 25-30%
Requirements:
- 6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience)
- Experience in oncology preferred
- Experience in global trials preferred
- Experience with Electronic Data Capture systems preferred
Education Requirements:
- BS/BA degree in a life science, RN, or related field