Clinical Study Lead

Overview

We are seeking a qualified contractor to assume the role of Clinical Study Lead for a series of companion diagnostic clinical studies. This position presents a unique opportunity to contribute to impactful projects within a dynamic environment.

Engagement Details

Start Date: 01 October

Duration: 6 month

Workload: 100%

Location: remote

Project Language: english

Responsibilities

• Develop and implement all study-related documentation, including protocols, investigator brochures, informed consent forms, contracts, and reports, ensuring compliance with applicable regulations, guidelines, and standard operating procedures (SOPs).
• Act as a representative of the Clinical Affairs function in both internal cross-functional teams and with external partners, including pharmaceutical companies and central laboratories.
• Oversee the preparation of study sites, ensuring that equipment and training align with the clinical protocol and organizational SOPs.
• Lead a clinical sub-team comprising Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs), providing project-specific training and facilitating regular meetings.
• Assist in the preparation of performance study applications for EU In Vitro Diagnostic Regulation (IVDR) submissions to National Competent Authorities (NCAs) and Ethics Committees (ECs), including addressing requests for information (RFIs).

Qualifications

• Several years of professional experience in the in vitro diagnostic devices sector; experience in other medical devices or pharmaceuticals will also be considered.
• Significant experience in Clinical Affairs or Operations is preferred; however, experience in product development, quality assurance, and regulatory affairs will be taken into account as part of overall qualifications.
• Familiarity with clinical study management and good clinical practice is preferred, with a strong emphasis on designing and authoring clinical performance study protocols and reports.
• Knowledge of regulatory requirements such as FDA CFR, ICH GCP, and IVDR is essential.
• Proficiency in Microsoft Office applications, particularly Word and Excel.
• Understanding of Electronic Data Capture (eDC), electronic Trial Master File (eTMF), and Clinical Trial Management Systems (CTMS) or similar clinical operations tools.
• Excellent command of the English language, both spoken and written.

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