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Elite Clinical Network · 1 day ago

Site Manager

Denver, CO

Full-time

Onsite

Senior Level

5+ years exp

Elite Clinical Network is a company focused on conducting clinical trials. The Site Manager is responsible for the operational oversight of a clinical research site, ensuring compliance with regulatory requirements and alignment with company objectives while managing site staff and resources.

Consumer SoftwareHealth CareMarket ResearchPharmaceutical

Responsibilities

Manage all aspects of study execution from initiation through close-out to ensure adherence to projected timelines, high-quality protocol execution, and full compliance with internal ECN processes

Monitor and manage site-level revenue and expenses, ensuring financial targets are achieved. Collaborate with finance and leadership to track study billing, manage budgets, review payment schedules, and control costs to maximize site profitability and financial health

Create and implement detailed operational plans tailored to each study, including staffing, equipment, resource needs, and timelines, ensuring effective resource allocation and protocol compliance

Ensure accurate and timely completion of all regulatory reporting in accordance with GCP, ICH guidelines, and applicable local, national, and international regulations. Maintain documentation and audit readiness at all times

Oversee data integrity through routine documentation review, source verification, and efficiency checks. Ensure accuracy, completeness, and compliance of all collected data with study protocols and regulatory expectations

Maintain accountability for timely and accurate data entry and reporting. Monitor submission timelines to ensure sponsor and regulatory deadlines are met without exception

Meet or exceed all participant recruitment and enrollment goals by implementing proactive recruitment strategies and monitoring enrollment performance

Serve as the primary point of contact for Sponsors, CROs, and vendors, ensuring timely communication, resolution of operational issues, and alignment on study deliverables

Provide comprehensive training and onboarding for new site staff, ensuring protocol requirements, regulatory guidelines, and site-specific procedures

Plan and lead regular site team meetings to foster communication, address operational challenges, share study updates, and ensure consistency across clinical and administrative functions

Collaborate closely with the Regional Site Manager and attend required leadership meetings to ensure alignment of study progress with organizational priorities and performance targets

Oversee the evaluation, selection, and performance management of research staff to ensure staffing adequacy, team competency, and support for study operations

Maintain and routinely audit the site’s master training file, including staff certifications, licensure, and training records, to ensure compliance and readiness for inspections

Develop and maintain collaborative relationships with monitors, project managers, vendors, and sponsor representatives, facilitating streamlined operations and issue resolution

Develop and maintain assigned source documentation in accordance with protocol specifications, ensuring data quality, consistency, and real-time updates throughout the study lifecycle

Review monitoring visit follow-up letters promptly, identify findings or recommendations, and implement/document corrective and preventive actions to maintain compliance and quality standards

Monitor site and clinic performance trends regularly, proactively identifying areas for improvement and implementing corrective strategies to drive operational efficiency and excellence

Cultivate and maintain a professional, respectful working relationship with all affiliated physicians, ensuring alignment of clinical responsibilities and fostering site-level collaboration

Identify and engage additional physicians when needed to support protocol-specific assessments or examinations, ensuring study timelines and requirements are consistently met

Qualification

Clinical research managementGCP complianceMicrosoft OfficeRealTime CTMSPatient facing experienceTeam leadershipProject managementCommunication skillsProblem-solving

Required

Bachelor's degree in a scientific or healthcare field

Minimum of 5 years in clinical research management or other applicable management experience

Excellent written and verbal communication skills

Patient facing experience required (EKG's, Vital Signs, Phelbotomy, etc.)

Advanced management skills with the ability to lead a team

Ability to organize and manage multiple projects & priorities

Commitment to the vision and mission of Elite Clinical Network

Experience working with multiple IRBs, Sponsors/CROs, and vendors

Extensive knowledge and mastery of Microsoft Office, RealTime CTMS, GCP and other industry standards

Demonstrated ability to learn quickly and generate solutions to complex problems

Ability to work independently, within a multi-disciplinary team, as well as with sponsors and vendors

On-Site Presence: Site Managers are expected to be physically present at their assigned clinic Monday through Friday during standard operating hours, for a minimum of 8 hours per day and 40 hours per week

Time Off Protocol: If time off is needed, prior notification must be given to your Regional Site Manager. Approval should be obtained before it is taken

Coverage Responsibility: It is the Site Manager's responsibility to ensure that all operational duties are adequately covered during any absence. This includes coordinating with appropriate team members to maintain seamless clinic operations

Timely Response Requirement: All emails must be reviewed and responded to within 24 hours of receipt to ensure timely communication and operational efficiency

Inclusion of Leadership: The Regional Site Manager (RSM) must be copied (CC'd) on all email correspondence related to site operations, clinical activities, or sponsor communications

Site staff must inform all sponsor representatives, Clinical Research Associates (CRAs), and CRO contacts to include the Regional Site Manager on all future communications involving the site. This ensures transparency, accountability, and consistent oversight of study activities