Feasibility Manager
Position Summary:
The Feasibility Manager will play a crucial role in assessing the viability of clinical trials across our network of sites, performing critical tasks such as conducting comprehensive feasibility assessments, evaluating study protocols, and collaborating with internal teams to ensure the successful execution of clinical trials.
Key Responsibilities:
Gathers and analyzes historical data, site metrics, and patient demographics to provide evidence-based recommendations on site selection and feasibility.
Identifies and screens potential clinical research sites based on study-specific criteria including patient demographics, geographic location, and investigator expertise.
Collaborates with site staff to assess their capacity, capability, and resources to conduct the proposed trial.
Conducts detailed feasibility assessments to evaluate site capacity for patient recruitment, adherence to protocol, and data quality standards.
Analyzes the availability of target patient populations with each site’s catchment area to ensure adequate recruitment potential, estimating recruitment timelines and identifying strategies to mitigate recruitment challenges.
Provides analysis for site-specific cost considerations and budget development, including staffing, equipment, and other resources.
Assesses local regulatory requirements and their impact on site feasibility and study timelines.
Works closely with internal study teams, investigators, and sponsors to communicate feasibility findings and address any site-specific concerns.
Prepares comprehensive feasibility reports and presents feasibility results to internal stakeholders, providing actionable insights to support study planning.
May perform other job-related duties as requested or required.
Skills/Abilities:
Excellent interpersonal and communication skills.
Strong understanding of clinical trial methodology and regulatory guidelines required.
Sound knowledge of medical terminology.
Sound knowledge of ICH/GCP, Regulatory requirements, FDA and HIPAA policies and practices.
Education/Experience:
Bachelor’s degree required, preferably in life sciences, health care, or a related field.
At least 3 years of experience in site feasibility or study start-up at a clinical research multi-site organization.
The Feasibility Manager will play a crucial role in assessing the viability of clinical trials across our network of sites, performing critical tasks such as conducting comprehensive feasibility assessments, evaluating study protocols, and collaborating with internal teams to ensure the successful execution of clinical trials.
Key Responsibilities:
Gathers and analyzes historical data, site metrics, and patient demographics to provide evidence-based recommendations on site selection and feasibility.
Identifies and screens potential clinical research sites based on study-specific criteria including patient demographics, geographic location, and investigator expertise.
Collaborates with site staff to assess their capacity, capability, and resources to conduct the proposed trial.
Conducts detailed feasibility assessments to evaluate site capacity for patient recruitment, adherence to protocol, and data quality standards.
Analyzes the availability of target patient populations with each site’s catchment area to ensure adequate recruitment potential, estimating recruitment timelines and identifying strategies to mitigate recruitment challenges.
Provides analysis for site-specific cost considerations and budget development, including staffing, equipment, and other resources.
Assesses local regulatory requirements and their impact on site feasibility and study timelines.
Works closely with internal study teams, investigators, and sponsors to communicate feasibility findings and address any site-specific concerns.
Prepares comprehensive feasibility reports and presents feasibility results to internal stakeholders, providing actionable insights to support study planning.
May perform other job-related duties as requested or required.
Skills/Abilities:
Excellent interpersonal and communication skills.
Strong understanding of clinical trial methodology and regulatory guidelines required.
Sound knowledge of medical terminology.
Sound knowledge of ICH/GCP, Regulatory requirements, FDA and HIPAA policies and practices.
Education/Experience:
Bachelor’s degree required, preferably in life sciences, health care, or a related field.
At least 3 years of experience in site feasibility or study start-up at a clinical research multi-site organization.