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.

Essential Duties:

Study Start-Up and Planning:· Collaborating 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.· Completing and/or confirming feasibility questionnaires, as necessary· Responsible for enrollment strategy to achieve and/or exceed enrollment objectives and working with patient engagement as needed for studies· Identifying potential risks and developing mitigation strategies. · Financial Management and resource allocation for the trial. Responsible for timely activation of clinical trials at sites and ensuring the site is prepared to successfully execute clinical trials. · Site-level Vendor managementSite Management and Oversight:· Manage overall operation of the sites including project plans and resources to ensure compliance with the protocol and contract.· Participation in preparation and support during all monitoring visits as needed · Tracking site enrollment and decision-making for enrollment enhancement· Managing quality issues and corrective actions· Ensuring site compliance with GCP guidelines and Good Documentation Practices.· Coaching, mentoring, and training site staff. to ensure efficient and high-quality site operations· Maintain an overview of clinical trial operational status or risks and proactively communicate the progress, issues, or protocol revisions that may impact timelines and costs.· Assists with an understanding of protocols and study procedures.Team Leadership and Communication:· Leading site-level staff and managing performance· Collaborate effectively and interact professionally with team, patients, and study staff (including sponsor/CRO). · Developing customer relationships with site CRAs and other sponsor/CRO staff· Support business development and operations to achieve study awards· Providing regular updates on trial progress to stakeholders and compiling metrics.· Responsible for site business reviews at an established cadenceCompliance and Regulatory Oversight:· Ensuring adherence to all applicable regulatory requirements (ICH-GCP). · Preparing for sponsor/CRO and/or regulatory audits. · Act as a liaison to the Investigator(s) to ensure appropriate investigator oversight is maintained.· Perform periodic quality reviews of the investigator site file, protocol deviations, eSource, and other metrics to determine any trends and training needs

SUPERVISORY RESPONSIBILITIES:

·Monitor employee productivity and provide constructive feedback and coaching.· Manage and supervise the day-to-day operations of assigned team members including managing performance metrics, accountability outcomes and work distribution, performance evaluations· Assess the work performance of direct reports and identify areas that need improvement· Set and communicate goals for performance and deadlines in ways that comply with the company’s plans and vision, in addition to departmental objectives.· Grow and develop the site team including development of succession plans and individual development plans· Ensure that business goals, deadlines, and performance standards are met according to set benchmarks and established company policy.· Recommend new employees to the TalentServices team based on an assessment of their performance.· Ensure adherence to legal and company policies and procedures and partner 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· Knowledge of 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· 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.· 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 trainings, 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. Familiarity 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)
• Two (2) 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
• Quality management and corrective action experience
• CCRC or CCRP certification a plus