ThermoFisher Scientific
Patient Recruitment & Retention Strategy Lead - FSP
ThermoFisher Scientific, Cambridge, Massachusetts, us, 02140
Work Schedule
Standard (Mon-Fri)
Environmental Conditions Office
Job Description This role is part of the Site and Patient Engagement team within Trial Operations at the client. The Patient Recruitment & Retention Strategy Lead encompasses strategic leadership and oversight of patient recruitment efforts across multiple clinical trials/indications across the client. This role will work with the global clinical team and leaders to understand patient recruitment needs at a disease and study level and developing appropriate solutions. The role is crucial in ensuring the successful recruitment and retention of participants in clinical trials. Expected travel: 10-15%.
ROLES AND RESPONSIBILITIES
Strategic Planning:
Develop and execute comprehensive patient recruitment strategies with the objectives and timelines of each clinical trial. This involves analyzing study protocols, understanding the target patient populations and identifying effective recruitment channels. Partners with study leaders and cross-functional partners on the diversity strategy and actively contributes to the indication-specific diversity plan.
Stakeholder Collaboration:
Collaborate with Indication Development Teams and cross-functional partners, including Trial Operations, medical affairs, regulatory affairs, global patient advocacy, and Global Sourcing & Vendor Alliance Management (GloSAM). Ensure alignment of recruitment strategies with study protocols and regulatory requirements. Provide coaching and mentoring to other team members. Provide input to procedures/SOPs/Wis and related documents. Participate in workstreams.
Budget Management:
Manage recruitment budgets for multiple clinical trials in coordination with the appropriate Clinical Operations Development Lead (CODL).
Vendor Management
: Oversee relationships with external vendors and recruitment agencies involved in patient outreach, screening and enrollment activities. Evaluate vendor performance. This includes the review and coordination of all approvals of patient recruitment materials. Collaborate with GloSAM to negotiate contracts and Quality team to ensure compliance.
Data Analysis and Metrics Reporting:
Utilize data analytics tools to track recruitment metrics, monitor progress and identify trends. Implement quantitative methods for measuring the impact of specific recruitment tactics. Leverage metrics to inform recruitment strategy across IDTs and implement continuous improvement. Collaborate with data science partners on how we can leverage data science approaches and data sources for identifying geographic regions of interest and site and patient identification to optimize recruitment strategy. Generate regular reports for senior management and study teams providing insights and recommendations for optimization.
Ethical and Regulatory Compliance:
Ensure that all recruitment activities adhere to ethical standards, regulatory requirements and Good clinical Practice (GCP) guidelines.
Continuous Improvement:
Implement process improvements and best practices to enhance recruitment efficiency and effectiveness. Ensure best practices and lessons learned are shared across trials/indications/assets. Stay abreast of industry trends, emerging technologies and innovative recruitment solutions.
Patient Engagement and Retention
: Develop strategies that engage patients throughout the clinical trial lifecycle, fostering a positive experience and positioning the client as Sponsor of Choice for clinical trial participation.
Risk Management:
Identify potential risks and challenges related to patient recruitment and collaborate with CRO/vendor to develop contingency plans to ensure study timelines are met.
SKILLS AND COMPETENCIES
Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial
Ability to work with vendors and external stakeholders with timely communications
Highly organized with a positive attitude; Works well through change and shifting priorities
Strong planning, organizational and project management skills
Ability to communicate effectively and professionally
EDUCATION, EXPERIENCE AND QUALIFICATIONS
Bachelor's degree in a scientific, marketing or communications discipline
10+ years of experience
Relevant industry experience (pharma, biotech, CRO required
Experience implementing or overseeing patient recruitment strategy
Experience leading implementation and strategy development teams and working in a global environment
Auto-immune and/or oncology clinical trial background is a plus
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Environmental Conditions Office
Job Description This role is part of the Site and Patient Engagement team within Trial Operations at the client. The Patient Recruitment & Retention Strategy Lead encompasses strategic leadership and oversight of patient recruitment efforts across multiple clinical trials/indications across the client. This role will work with the global clinical team and leaders to understand patient recruitment needs at a disease and study level and developing appropriate solutions. The role is crucial in ensuring the successful recruitment and retention of participants in clinical trials. Expected travel: 10-15%.
ROLES AND RESPONSIBILITIES
Strategic Planning:
Develop and execute comprehensive patient recruitment strategies with the objectives and timelines of each clinical trial. This involves analyzing study protocols, understanding the target patient populations and identifying effective recruitment channels. Partners with study leaders and cross-functional partners on the diversity strategy and actively contributes to the indication-specific diversity plan.
Stakeholder Collaboration:
Collaborate with Indication Development Teams and cross-functional partners, including Trial Operations, medical affairs, regulatory affairs, global patient advocacy, and Global Sourcing & Vendor Alliance Management (GloSAM). Ensure alignment of recruitment strategies with study protocols and regulatory requirements. Provide coaching and mentoring to other team members. Provide input to procedures/SOPs/Wis and related documents. Participate in workstreams.
Budget Management:
Manage recruitment budgets for multiple clinical trials in coordination with the appropriate Clinical Operations Development Lead (CODL).
Vendor Management
: Oversee relationships with external vendors and recruitment agencies involved in patient outreach, screening and enrollment activities. Evaluate vendor performance. This includes the review and coordination of all approvals of patient recruitment materials. Collaborate with GloSAM to negotiate contracts and Quality team to ensure compliance.
Data Analysis and Metrics Reporting:
Utilize data analytics tools to track recruitment metrics, monitor progress and identify trends. Implement quantitative methods for measuring the impact of specific recruitment tactics. Leverage metrics to inform recruitment strategy across IDTs and implement continuous improvement. Collaborate with data science partners on how we can leverage data science approaches and data sources for identifying geographic regions of interest and site and patient identification to optimize recruitment strategy. Generate regular reports for senior management and study teams providing insights and recommendations for optimization.
Ethical and Regulatory Compliance:
Ensure that all recruitment activities adhere to ethical standards, regulatory requirements and Good clinical Practice (GCP) guidelines.
Continuous Improvement:
Implement process improvements and best practices to enhance recruitment efficiency and effectiveness. Ensure best practices and lessons learned are shared across trials/indications/assets. Stay abreast of industry trends, emerging technologies and innovative recruitment solutions.
Patient Engagement and Retention
: Develop strategies that engage patients throughout the clinical trial lifecycle, fostering a positive experience and positioning the client as Sponsor of Choice for clinical trial participation.
Risk Management:
Identify potential risks and challenges related to patient recruitment and collaborate with CRO/vendor to develop contingency plans to ensure study timelines are met.
SKILLS AND COMPETENCIES
Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial
Ability to work with vendors and external stakeholders with timely communications
Highly organized with a positive attitude; Works well through change and shifting priorities
Strong planning, organizational and project management skills
Ability to communicate effectively and professionally
EDUCATION, EXPERIENCE AND QUALIFICATIONS
Bachelor's degree in a scientific, marketing or communications discipline
10+ years of experience
Relevant industry experience (pharma, biotech, CRO required
Experience implementing or overseeing patient recruitment strategy
Experience leading implementation and strategy development teams and working in a global environment
Auto-immune and/or oncology clinical trial background is a plus
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
#J-18808-Ljbffr