Senior Project Specialist, Single Sponsor

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

📋 Description

• Establish, manage, and finalize project files and study information, including KPIs, regulatory documentation, TMF, enrollment data, adverse event reports, protocol deviations, site supplies, IRB re-approvals, and data inquiries.

• Oversee and disseminate study-specific and financial reporting, which encompasses vendor/site invoices, investigator payments, forecasts, and associated information.

• Facilitate internal and external meetings as instructed by the Project Lead; prepare and circulate meeting minutes and action items.

• Follow up with team members on action items until resolution.

• Document KPI status, evaluate and communicate KPIs, and suggest action plans under the supervision of the Project Lead.

• Generate and provide customer status reports with guidance from the Project Lead.

• Ensure that study documents are archived in accordance with relevant guidelines and policies.

• Act as the project representative during internal and external audits when necessary.

• Assist in quality assurance activities, audit preparation, internal reviews, and the resolution of actionable issues.

• Serve as the primary contact for customers in the Project Lead's absence, consulting with the Project Director as required.

• Mentor and train Project Specialists.

⛳️ Requirements

• Equivalent experience, skills, and/or education will be taken into account.

• Capability to establish, manage, and finalize project files and study information across various databases and systems.

• Proficiency in maintaining and distributing study-specific and financial reports.

• Ability to lead or assist in internal and external meetings and follow up on action items.

• Skill in documenting and evaluating KPIs and preparing status reports.

• Familiarity with guidelines and policies pertaining to study document archiving.

• Competence in supporting quality assurance activities and audits.

• Capacity to provide customer support and mentor/train Project Specialists.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition among peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations provided when appropriate.