Description
Responsibilities- Select and manager vendors (e.g. CRO, central lab)
- Provide input to site selection and oversee site performance
- Develop and negotiate site budgets
- Review monitoring reports
- Provide input to study budget planning and management
- Prepare study materials, including protocols, laboratory manuals, informed consents, Case Report Forms, monitoring and communication plans
- Manage clinical trial materials
- Oversee finalization of data management and statistical analysis plans
- Review TLFs and clinical study reports
- Develop timelines to optimize the achievement of study goals and milestones
- Manager investigational drug supply including labeling, distribution and drug accountability
- Ensure quality and timely delivery of clinical study data
- Coordinate activities with other functional groups (Regulatory, Safety, Biostatistics
- Contribute to project clinical team meetings to provide timely and accurate operational updates, plans and recommendations
- Contribute to the development and review of Clinical SOPs
Qualifications
- BA/BS in Life Science or related discipline
- At least 8 years of experience managing Phase II & III clinical trials
- Ability to work within a team
- Excellent communication, interpersonal and team leadership skills
- Excellent communication skills. Problem solving and negotiation skills a must
- Attention to detail and highly organized; ability to prioritize multiple tasks
- Familiarity with multiple EDC platforms is a plus
- Some travel may be required