Site Team Leader

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Description

SUMMARY:

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. Working closely with Regional Site Directors and other Research Operations leaders, this individual will ensure the execution of clinical trial activities in compliance with all applicable regulations. This role will provide close and continued communication with site employees, provide training and mentoring to enhance performance and adherence to best practices. The STL will also ensure engagement of the team. 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. Responsibilities include site onboarding, maintaining site research readiness, coaching site staff, reviewing site metrics for decision-making, compiling and leading monthly business reviews, and ensuring quality oversight. Key development areas include Adverse Event reporting, Motivational Interviewing, regulatory and compliance updates, and operational changes related to program quality monitoring. By leveraging their expertise in site operations, this individual will craft and execute a strategic approach that enhances site performance, drives business outcomes, and supports the success of Site Operations across their region.

Requirements

ESSENTIAL DUTIES:

Operational & Project Management

• Manages financial and resource allocation for clinical trials.
• Collaborates with study teams and PMs to develop study plans for successful implementation of newly awarded trials. Ensuring adherence to study startup plans in accordance with timelines
• Ensures timely activation of clinical trials at sites by validating sites are prepared to successfully execute clinical trials.
• Reviews clinical trial agreements and budgets, and negotiates with CROs and Sponsors as needed
• Identifies potential risks and develops mitigation strategies.
• Provides regular updates on trial progress to stakeholders and compiling metrics.
• Conducts site business reviews at an established cadence
• Manages overall operation of the sites including project plans and resources to ensure compliance with the protocol and contract.
• Participates in preparation and support during all monitoring visits as needed
• Tracks site enrollment and decision-making for enrollment enhancement
• Manages quality issues and ensures appropriate corrective actions are taken
• Ensures sites are compliant with GCP guidelines and Good Documentation Practices.
• Maintains an overview of clinical trial operational status or risks and proactively communicate the progress, issues, or protocol revisions that may impact timelines and costs.
• Verifies understanding of protocols and study procedures, ensures any gaps are resolved
• Ensures adherence to all applicable regulatory requirements (ICH-GCP).
• Prepares for sponsor/CRO and/or regulatory audits.
• Acts as a liaison to the Investigator(s) to ensure appropriate investigator oversight is maintained.
• Performs periodic quality reviews of the investigator site file, protocol deviations, eSource, and other metrics to determine any trends and training needs
• Site-level Vendor management

Business Development & Growth

• 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, as necessary
• Ensures business goals, deadlines, and performance standards are met according to set benchmarks and established company policy.
• Develops effective enrollment strategies to achieve and/or exceed enrollment objectives and collaborates with other internal departments as needed
• From start-up through close out, collaborates with study teams and PMs to develop study plans for successful implementation of newly awarded trials. Ensuring adherence to study startup plans in accordance with timelines.
• Interprets complex clinical protocols, regulatory requirements, and site performance data to identify operational challenges early, recommend evidence-based solutions, and adapt trial strategies to maintain compliance and efficiency.
• Troubleshoots barriers to study conduct-such as site performance issues, data discrepancies, or supply chain delays-by collaborating cross-functionally and implementing timely, sustainable corrective actions.
• Monitors trial metrics (e.g., enrollment rates, data query resolution times, monitoring visit completion) to identify trends, assess risk, and adjust operational plans to meet study timelines and quality standards.
• Develops and executes proactive recruitment and retention strategies, including site engagement initiatives, patient outreach plans, and enrollment forecasting, to achieve or exceed enrollment targets.

Team Management

• Manages and supervises the day-to-day operations of assigned team members including managing performance metrics, accountability outcomes and work distribution, performance evaluations
• Coaches, mentors, and trains site staff. to ensure efficient and high-quality site operations
• Collaborates effectively and interacts professionally with team, patients, and study staff (including sponsor/CRO).
• Monitors employee productivity; provides constructive feedback and coaching.
• Assesses the work performance of direct reports and identify areas that need improvement
• Grows and develops team by using succession plans and individual development plans
• Recommends new employees to the TalentServices team based on an assessment of their performance.
• Ensures adherence to legal and company policies and procedures and partners with TalentServices to undertake disciplinary actions if needed.

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, including the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.
• Excellent written and verbal communication skills, including the ability to present ideas and suggestions clearly and effectively.
• Strong organizational skills ability to accomplish multiple tasks within the agreed-upon timelines, through effective prioritization of duties and functions in a fast-paced environment.
• Excellent critical thinking and problem solving skills.
• Demonstrated ability using reporting and metrics to interpret data, identify trends, and provide insight
• Proven track record of building and maintaining solid relationships with both internal and external stakeholders in a collaborative manner.
• Self-motivated with the ability to work independently to complete tasks, respond to department requests and collaborate with others to utilize their resources and knowledge to identify quality solutions.
• Proven track record of healthcare industry or research experience and building successful relationships.
• Demonstrated ability to be a prompt decision maker with strong problem-solving skills, while maintaining a high degree of flexibility in adapting to a rapidly changing environment.
• Demonstrated ability to deliver educational presentations, during both small and large group training sessions, to customers, peers, and prospects, with measurable results.
• Advanced proficiency with Microsoft 365 applications (Word, Excel, Outlook, PowerPoint, and Teams) and various EDC (Electronic Data Capture) methods.
• Proficient with CTMS (Clinical Trial Management Systems)

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, including experience as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC)
• 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 including change management, managing matrix teams, resourcing management and utilization
• Two (2) or more years of site and study financial management skills
• CCRC or CCRP certification a plus