Site Activation Leader

Key Accountabilities:

Accountability

Supporting Activities

Site Activation Leadership and Strategy

Lead site activation planning and strategy development for assigned clinical studies

Oversee site activation milestones and deliverables to ensure timely and quality study start-up from site feasibility through last site activation

Monitor and report on site activation progress across multiple studies and mitigate potential delays or risks

Lead cross-functional teams to resolve complex site activation challenges and issues

Develop, coordinate, and execute the study critical path plan.  This includes but is not limited to Site Feasibility, Site Selection, Regulatory Green Light, Site Initiation, and Site Activation, as well as System Set-up, pertinent TMF/EDL Management, EC & RA/ MoH Strategy, ICF Customization, Risk Mitigations, Site Activation Requirements & Relevant Tools, Documents, and Reporting

Team Leadership and Stakeholder Management

Provide guidance to site activation team members

Serve as liaison between project management, site start-up teams, and site activation functions

Lead regular communication with internal teams regarding site activation status and actions

Coordinate with clinical operations leadership to align site activation activities with overall study objectives

Manage client relationships and communication regarding site activation timelines and deliverables

Client Relationship Management and Business Development

Serve as the Study Start-Up (SSU) Subject Matter Expert (SME) for designated client accounts, providing strategic guidance, best practice recommendations, and technical expertise to ensure optimal study initiation and site activation outcomes

Support business development activities by providing site activation expertise in proposals and bid pursuit meetings (BPMs)

Process Development and Quality Leadership

Implementation of standardized site activation processes and best practices across studies

Analyze site activation metrics and drive process optimization initiatives

Ensure compliance with regulatory requirements and company SOPs during site activation

Contribute to the development and maintenance of site activation procedures and templates

Champion quality initiatives to enhance site activation efficiency and effectiveness

System Leadership and Strategic Documentation

Lead utilization of CTMS, EDC, IXRS, and TMF systems to optimize site activation workflows

Oversee accurate documentation of site activation processes and outcomes across studies

Drive project planning system optimization related to site activation timelines and resource allocation

Ensure proper data integrity and system maintenance for assigned portfolio

Generate strategic reports and metrics using clinical trial management systems for leadership review

Skills:

Excellent proficiency with CTMS, EDC, IXRS, and TMF systems

Strong project planning and management software

Comprehensive knowledge of clinical trial regulations and Good Clinical Practice

Deep understanding of site activation processes and requirements

Extensive familiarity with clinical research operations and workflows

Advanced project management and strategic planning abilities

Excellent written and verbal communication skills with senior stakeholders

Strong management capabilities

Excellent problem-solving and critical thinking skills

Attention to detail and accuracy in complex documentation

Excellent time management and ability to prioritize multiple complex projects

Cross-functional leadership and coordination

Change management and process improvement expertise

Client relationship management and business development support

Knowledge and Experience:

4-7 years of experience in clinical research operations with site activation leadership

Proven experience leading site activation teams and processes

Comprehensive knowledge of clinical trial start-up processes and requirements

Strong background in regulatory compliance in clinical research

Extensive experience working with clinical research sites and investigators

Demonstrated understanding of clinical trial timelines and milestone management

Experience with process improvement and team leadership

Education:

Bachelor's degree in Life Sciences, Healthcare, Business Administration, or related field

Advanced training and experience in clinical operations, site management, and/or project management preferred