Labcorp Drug Development is currently looking to recruit a Start-up Associate or a Specialist, who would like to continue their career in Start-up at Labcorp Drug Development in Belgium.

The Start-up Specialist acts as primary contact with the assigned investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB and any other local applications are made within the timelines agreed with project management and Start-up team and that documentation meets the specifications required by applicable regulations and sponsor.

Also, the Start-up Specialist is a local expert in project start-up activities for a particular country or region and acts as a 'knowledge resource' to mentor and train new hires and less-experienced department colleagues.

Essential Job Duties

• Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance
• Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality, and applicable laws and guidelines
• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
• Proactively manage sites to ensure timely site activation and escalate study issues appropriately and in a timely fashion.
• Participate in team meetings to progress trials and identify site issues that might impact the timelines.
• When needed, assist in the preparation of Site Activation project-specific plans and provide accurate projections and timelines to study teams agreed with the Sponsor Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.
• Liaise with Labcorp Drug Development Regulatory department regarding document submission requirements, if applicable.
• Prepare submissions to IRB/IEC, and regulatory authorities if Global Regulatory Services (GRS) requires input. Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/ approval issues. Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis making Labcorp Drug Development ready for an audit at any time.
• May support the negotiation of site contracts and budgets with sites, if applicable, and track the progress of the contract and budget milestones/developments, intervening and escalating as appropriate.
• Undertake tasks delegated by senior team members, depending upon country and situational requirements.
• Perform other duties as assigned by management.

Education/Qualifications:

• Minimum of 2 years of experience in clinical development or start-up/ regulatory process.
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites
• Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them
• Ability to communicate fluently in English, French and Dutch;

Experience:
Excellent skills required in the following areas:

• Strong service orientation
• Autonomous
• Planning & organizing
• Relationship management
• Process competence
• Coordination skills
• Multi-tasking
• Analytical thinking
• Negotiation
• Prioritizing

We are looking forward to meeting you!

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.