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Company

ICON Strategic Solutions · 5 hours ago

Lead Site Activation Manager

United States

Full-time

Remote

Senior Level, Lead/Staff

10+ years exp

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Pharmaceuticals

Actively Hiring

Hiring Manager

Trent Hampson

Insider Connection @ICON Strategic Solutions

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Responsibilities

Responsible for activation of all study sites to meet project timelines

Responsible for oversight of SAMs assigned to trial

Interaction with other departments to communicate and negotiate timelines , including Clinical Budget Management and Regulatory Affairs

Facilitate Informed Consent Form review and negotiation process for study, country and site templates

Effectively communicates project risk and mitigation strategies to Study Team members

Lead problem solving and resolution efforts to include management of risk, contingencies, and issues

Identify quality issues within the study to implement appropriate corrective action plans.

Facilitate generation and finalization of documents and applicable translations for global regulatory and EC submissions according to applicable SOPs and WIs

Ensures data integrity by overseeing data cleaning efforts for internal information systems, setting standards for data entry and maintenance

Mentors and coaches junior staff as assigned

Performs other duties as assigned

Qualification

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Clinical study start-upRegulatory requirementsInformed Consent FormData integrity oversightProject managementCoachingICH GuidelinesGCPMentoring

Required

Organizational skills to independently manage all aspects of study activation and meet project deadlines

Experience and expertise in managing high‐volume clinical study start‐up activities

Strong understanding of global study start‐up requirements and activities, including Informed Consent Form requirements

Excellent communication (written and verbal) skills to be able to interact with internal groups (Legal, Medical Monitors, Regulatory Affairs, etc.) as well as external groups (e.g. Investigators and CRO, if applicable)

Able to proactively identify project opportunities, challenges, risks and implement appropriate actions with minimal supervision

Ability to work in a matrix, cross‐functional team

Demonstrates thorough knowledge and understanding of key regulatory authorities and regulatory requirements, ICH Guidelines, and GCP’s governing the start‐up of clinical trials

B.S. or Advanced Degree (or equivalent degree/experience in the opinion of the Hiring Manager) and minimum of 10 years of relevant work experience

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs

Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead

Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others