Site Activation Manager

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

📋 Description

• Collaborate with key functional areas across clinical trials and business operations

• Identify and assess Site Start-Up challenges, regulatory routes, patient recruitment issues, and project risks

• Ensure that project deliverables align with both internal and client expectations

• Cultivate and sustain customer relationships for designated projects

• Oversee project start-up deliverables throughout the entire project lifecycle

• Manage regulatory maintenance tasks, amendment submissions, and communications with authorities and ethics committees, along with import/export license extensions

• Supervise amended clinical trial agreements and investigator budgets with study sites

• Manage overall Site Start-Up schedules and adjust plans as necessary

• Create integrated timelines and provide weekly updates, including mitigation strategies for timing risks and gaps

• Prepare and deliver presentations on Site Start-Up strategies and statuses during client meetings

• Review project budgets in relation to milestones and profitability targets; implement corrective actions when required

• Monitor out-of-scope tasks through backlog assignments

• Prepare essential submission documents and clinical trial application dossiers for amendments

• Conduct Regulatory Impact Assessments and supervise second-level reviews

• Assist in updating master Subject Information Sheets and Informed Consent Forms

• Oversee the compilation, quality review, and submission of country-specific applications

• Contribute to initiatives aimed at improving the Site Start-Up department

• Submit pertinent documents to the Trial Master File in accordance with company SOPs and sponsor requirements

• Perform other assigned duties related to work

⛳️ Requirements

• Equivalent experience, skills, and/or educational background will also be taken into account

• Ability to work collaboratively with Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management, and Medical Writing teams

• Understanding of Site Start-Up procedures and project regulatory pathways

• Capability to analyze complex issues and make informed business decisions

• Proficiency in managing project deliverables, forecasts, reports, updates, risks, timelines, and budgets

• Familiarity with life-cycle maintenance regulatory activities, including study maintenance and amendment submissions

• Experience in managing clinical trial agreements, investigator budgets, communications with competent authorities and ethics committees, and import/export license extensions

• Skill in preparing core submission documents and clinical trial application dossiers for amendments

• Competence in conducting Regulatory Impact Assessments

• Ability to create or update Subject Information Sheets (SIS) and Informed Consent Forms (ICF)

• Proficiency in overseeing the collation, quality review, and submission of country-specific applications

• Ability to adhere to Standard Operating Procedures, controlled document requirements, and Sponsor specifications

• Proficiency in utilizing industry-standard tools for planning and managing scope, timelines, resources, and budgets

🏝️ Benefits

• Opportunities for career development and advancement

• Supportive and engaged management

• Training in technical and therapeutic areas

• Recognition from peers

• Comprehensive total rewards program

• Inclusive workplace culture

• Minimal travel may be required (up to 25%)