Site Activation Lead

This is a fully remote position, open to applicants in Poland.

📋 Description

• Propel clinical trial start-up initiatives by comprehending client goals and aiding in the planning of country and site distribution.

• Oversee daily site start-up and activation tasks.

• Collaborate with Clinical Operations teams and TAU partners to enhance study start-up metrics and implement effective processes.

• Offer guidance, oversight, and mentorship to the FSP Site Start Up team.

• Execute protocol study start-up, country and site selection, study start-up planning, and modeling activities.

• Develop country-specific Informed Consent Forms (ICFs) based on the Master ICF.

• Implement site start-up standards across project portfolios and facilitate ongoing improvements.

• Direct the collection and analysis of data impacting study start-up timelines.

• Utilize industry tools and data sources to provide start-up timeline and performance metrics for forecasting purposes.

• Confirm site-level deliverables with the internal team and monitor compliance.

• Identify potential delays, enhance performance, and escalate instances of non-performance.

• Lead the internal FSP site start-up team and execute the Start Up Project Plan.

• Ensure timely delivery of client and CRO-supported sites to Ready To Enroll status.

• Address escalated site start-up challenges in collaboration with the Study Manager.

⛳️ Requirements

• Bachelor’s degree or international equivalent in a life science field.

• A minimum of 4 years of experience in Clinical Operations, Project Management, study start-up, and trial optimization.

• Progressive responsibilities within a pharmaceutical company, CRO, or a relevant industry vendor.

• At least 2 years of direct experience in site activation and management of study start-up processes for clinical research studies at a sponsor or CRO.

• Familiarity and expertise in country-level ICF creation and requirements.

• Proficient in software models and database structures.

• Capability to interpret data and facilitate data-driven decision-making processes.

• In-depth knowledge of principles influencing country/site start-up and study start-up strategies.

• Legal eligibility to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• An inclusive and accessible workplace.

• Reasonable accommodations available during the recruitment process.