Site Activation Leader

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the planning and strategy development for site activation in assigned clinical studies, managing milestones and deliverables from site feasibility to the activation of the last site.

• Create, coordinate, and implement critical path plans for studies, which include site feasibility assessments, site selection, obtaining Regulatory Green Light, site initiation, activation, system setup, management of the Trial Master File and Expected Document List, ethics committee and regulatory authority or Ministry of Health strategies, customization of informed consent forms, risk mitigation, activation requirements, tools, documents, and reporting.

• Track and report on site activation progress across various studies, identify potential delays and risks, and lead cross-functional teams to address complex activation challenges.

• Offer guidance to site activation team members and act as a liaison between project management, site start-up teams, site activation functions, and clinical operations leadership.

• Manage relationships and communications with clients concerning site activation timelines and deliverables, serving as the Study Start-Up Subject Matter Expert for specific client accounts.

• Provide strategic insights, best practice suggestions, and technical expertise to enhance study initiation and site activation results.

• Contribute to business development efforts by offering site activation expertise during proposal submissions and bid pursuit meetings.

• Establish standardized site activation processes and best practices, analyze activation metrics, and facilitate process optimization and quality improvement initiatives.

• Ensure adherence to regulatory standards and company Standard Operating Procedures while contributing to the development of site activation procedures and templates.

• Lead the utilization of Clinical Trial Management Systems, Electronic Data Capture, Interactive Response Technology, and Trial Master File systems to enhance site activation workflows.

• Supervise documentation, data integrity, system maintenance, timeline planning, and resource allocation within the assigned portfolio.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Healthcare, Business Administration, or a related discipline.

• 4-7 years of experience in clinical research operations with a focus on site activation leadership.

• Demonstrated experience in leading site activation teams and managing processes.

• In-depth understanding of clinical trial start-up processes and requirements.

• Solid background in regulatory compliance related to clinical research.

• Extensive experience interacting with clinical research sites and investigators.

• Proven grasp of clinical trial timelines and milestone management.

• Exceptional written and verbal communication skills, particularly with senior stakeholders.

• Skills in site activation leadership, strategic planning, and cross-functional coordination.

• Thorough knowledge of clinical trial regulations, Good Clinical Practice, site activation processes, and clinical research operations.

• Advanced abilities in project management, critical thinking, problem-solving, and process improvement.

• Keen attention to detail and accuracy in handling complex clinical trial documentation.

🏝️ Benefits

• Health, Vision & Dental Insurance

• Tuition Reimbursement

• Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts

• Work/Life Balance

• 401(k) with Company match

• Pet Insurance

• Paid time off

• Life insurance