Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

The PPD FSP Solution:

PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

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

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 argenx 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 in similar role

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