As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Role Details:

We are recruiting for our FSPx business in Hungary and are currently seeking to hire a sponsor-dedicated Clinical Team Lead (Local Trial Manager) with a permanent and full-time contract.

In this role, you will have a home-based contract and will focus on interventional trials.

The Clinical Team Lead is a member of the Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project. The CTL is responsible for coordinating and managing the clinical operations and local site services maintenance team, providing leadership and expertise to ensure successful execution of the site selection, clinical operations and IRB/IEC/regulatory maintenance project deliverables (quality, timeline, budget and scope).

This role requires collaboration within a matrix environment, proactive internal/external communication, and exceptional strategic planning, risk management and organizational skills.

Responsibilities include but are not limited to:

• Ensure the fulfilment of objectives defined in the protocol (number of patients and centres, timelines, budget)
• Ensure the ICH-GCP, corporate & local SOPs, and local regulations are respected and followed by all parties
• Participate in the submission of the project to the Ethics Committees and Health Authorities
• Validate the translation and adaptation of required documentation (protocol, informed consent form...), together with the Medical Advisors
• Actively ensure the obtaining of any study related documentation required for CTA application according to local regulation and Corporate & local SOPs, together with the Support Services Manager
• Finalize financial agreements (negotiation with the investigator, hospital, university, pharmacy, contractors, etc.).
• Participate in the validation of Case report Forms (CRFs) when applicable
• Select potential investigating centres according to their qualifications, clinical experience, research background and areas of expertise, in agreement with the Medical Advisors and Lead CTL
• Organize Local Investigator's Meetings and coordinate Investigator teams attendance to International Inv. Meetings
• Supervise, coordinate and lead CRA and CPA activities.
• Identify any specific problem related to the study, and propose possible solutions in agreement with Lead CTL
• Ensure good site activation. In particular ensures that the Investigators are perfectly informed of the specific features of the study and its organization
• Monitor study progress: conduct co-monitoring when necessary, evaluate Monitoring Visit Reports, measure gap between planned and actual values (visits, monitored & compiled CRFs, DRFs), alert the project team, and make the necessary decisions and actions to solve any study related matter under his/her responsibility
• Supervise recruitment and motivate investigating centres (follow-up, newsletters, information on study progress, etc.). Ensure that they have and maintain adequate equipment, materials and personnel to conduct the trial
• Conduct micro-planning follow-up in order to ensure that the committed targets (# active sites, # patients enrolled) are met in the committed administrative timelines, for the respective allocated clinical trials & Corporate Clinical Teams
• Monitor patient safety and drug tolerability by documenting adverse events, together with the GPE (Global Pharmacology and Epidemiology)
• Control the quality of data collected, technical validation of CRFs.
• Comply with the deadlines fixed by Data Management
• Handle issues specifically related to the study: critical events, patient narratives, Clinical Study Report

Education/Qualifications:
We are searching for a university graduate with a life science degree, who relishes working in a fast paced environment, on complex and demanding protocols.

If you are someone who is eager to constantly develop and improve while working in a friendly and collaborative team environment; then we are looking forward to meeting you.
Experience:

• Previous experience in managing clinical trials in pharmaceutical or CRO fields is preferred
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
• Ability and desire to lead others within a matrix environment on strict deadlines
• Fluency in Hungarian and English