ELLIGO HEALTH RESEARCH INC

Role Description The Site Team Leader (STL) plays a critical role in ensuring clinical trial sites operate efficiently, meet timelines, budget, and quality expectations through remote oversight of clinical sites. This role requires close collaboration with cross-functional teams, including site-level leadership, to drive successful clinical trial execution, develop site staff, and position sites for study awards. - Site onboarding and maintaining site research readiness - Coaching site staff and reviewing site metrics for decision-making - Compiling and leading monthly business reviews - Ensuring quality oversight - Key development areas include Adverse Event reporting, Motivational Interviewing, regulatory and compliance updates, and operational changes related to program quality monitoring Qualifications - Strong understanding of clinical trial methodologies and regulatory requirements - Excellent site management skills, including budgeting, timeline, and resourcing management - Advanced proficiency in Good Clinical Practice (GCP), Good Documentation Practice (GDP), relevant Standard Operating Procedures (SOPs) and regulatory requirements - Excellent coaching and mentorship skills - Strong interpersonal skills and able to deliver/receive daily constructive feedback appropriately - Ability to work cross functionally and succeed in a team environment - Proactive and timely follow-up skills - Excellent written and verbal communication skills - Strong organizational skills - Excellent critical thinking and problem solving skills - Demonstrated ability using reporting and metrics to interpret data - Proven track record of building and maintaining solid relationships - Self-motivated with the ability to work independently - Proven track record of healthcare industry or research experience - Demonstrated ability to be a prompt decision maker - Demonstrated ability to deliver educational presentations - Advanced proficiency with Microsoft 365 applications and various EDC methods - Proficient with CTMS (Clinical Trial Management Systems) Requirements - Manages financial and resource allocation for clinical trials - Collaborates with study teams and PMs to develop study plans - Ensures timely activation of clinical trials at sites - Reviews clinical trial agreements and budgets - Identifies potential risks and develops mitigation strategies - Provides regular updates on trial progress to stakeholders - Conducts site business reviews - Manages overall operation of the sites - Participates in preparation and support during monitoring visits - Tracks site enrollment and decision-making for enrollment enhancement - Manages quality issues and ensures corrective actions are taken - Ensures sites are compliant with GCP guidelines - Maintains an overview of clinical trial operational status or risks - Prepares for sponsor/CRO and/or regulatory audits - Acts as a liaison to the Investigator(s) - Performs periodic quality reviews of the investigator site file - Develops excellent customer relationships with site CRAs and other sponsor/CRO staff - Supports business development and operations to achieve study awards - Completes and/or confirms feasibility questionnaires - Ensures business goals, deadlines, and performance standards are met - Develops effective enrollment strategies - Interprets complex clinical protocols and regulatory requirements - Troubleshoots barriers to study conduct - Monitors trial metrics to identify trends - Develops and executes proactive recruitment and retention strategies - Manages and supervises the day-to-day operations of assigned team members - Coaches, mentors, and trains site staff - Collaborates effectively with team, patients, and study staff - Monitors employee productivity - Assesses the work performance of direct reports - Grows and develops team using succession plans - Recommends new employees to the Talent Services team - Ensures adherence to legal and company policies Education and Experience - Bachelor's degree in life sciences, pharmacy, or a related field or similar experience preferred - At least Seven (7) years clinical research experience - Four (4) or more years of experience utilizing CTMS, eTMF, eISF, eICF, and other clinical systems - At least four (4) years of experience in quality management and corrective action experience - Three (3) or more years of experience in line management - Two (2) or more years of site and study financial management skills - CCRC or CCRP certification a plus