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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Development Feasibility Manager
Remote, CA US
Posted: 08/28/2024
2024-08-28
2024-10-06
Employment Type:
Contract
Job Category: Operations and Development
Job Number: 3981
Job Description
Responsibilities:
- Maintain knowledge of external local clinical trial environment and assess impact on study design and execution
- Develop repository of Country Landscaping information (Country Site Intelligence Tool) to support operational delivery (eg, site capabilities, performance, regulatory landscape, treatment patterns etc.)
- Build internal/external engagement aiming at identifying new investigators and maintaining relationships with experts in specific therapy areas
- Understand patient flows and referral pathways in support of global/local operational delivery
- Partner with OFSMs and GCPM representatives to provide local country landscaping data for inclusion into the program and study design and to inform/support study placement, as applicable
- Support site selection within the country(ies) to participate in a study based on information gathered through COLA and site evaluation process.
- Support operating reviews by analyzing COLA participation and outcomes, predictability and delivery
- Master’s degree and 3 years of experience
OR
Bachelor’s degree and 5 years of experience - Experience of working in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
- Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
- Clinical trial management experience
- Operational performance experience
- International collaboration experience
- Knowledge of local country and international clinical trial management (including regulations & guidelines)