Development Feasibility Mgr
Apply NowCompany: Advanced Bio-Logic Solutions Corp
Location: Thousand Oaks, CA 91360
Description:
Description:
Note:
Responsibilities
Knowledge
Basic Qualifications
Basic Qualification:
Must Have Skill Sets:
Pay Rate between open rate based on experience.
"This posting is for Contingent Worker, not an FTE"
Note:
- Open market rate
- Remote - EST working hours preferred
- 1 year contract, with possible extension
- Shift/Schedule - Monday - Fri (flex time zones) 40 hrs a week
- Not a global role, just supports US
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 local operational delivery
- Partner with GFL 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 to participate in a study based on information gathered through FIRE and site evaluation process.
- Support operating reviews by analyzing FIRE participation and outcomes, predictability and delivery
Knowledge
- Knowledge of local country and international clinical trial management (including regulations & guidelines)
Basic Qualifications
- BA/BS/BSc or qualified nurse (RN)
- 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)
- Direct feasibility experience with sponsor and/or CRO company
- Preferred Qualifications
- BA/BS/BSc in life sciences 5 Pharma or biotech
- Masters Degree, M.D., PharmD 3/1
- 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
- Experience with feasibility and site intelligence: Citeline, TriNetX, Study Optimizer, DQS
Basic Qualification:
- Master's degree and 3 years of experience
- Bachelor's degree and 5 years of experience
Must Have Skill Sets:
- Direct Feasibility Experience
- Landscaping Assessment
- Intelligence Tool Experience
- Last time we sourced for this role was many clinical trial managers where they were involved with feasibility but did not have the direct experience with feasibility
- Scrubbed resume attached (we filled role in 2023 and 2024)
Pay Rate between open rate based on experience.
"This posting is for Contingent Worker, not an FTE"