Lead Monitor
nr ref: 232/9/2024/ML/88229
W Antal zajmujemy się rekrutacją od ponad 20 lat. Dzięki działaniu w 10 wyspecjalizowanych dywizjach, świetnie orientujemy się w aktualnych trendach branżowych. Precyzyjnie określamy specyfikę stanowiska, klasyfikując kluczowe umiejętności i niezbędne kwalifikacje. Naszą misją jest nie tylko znalezienie kandydata, którego kompetencje wpisują się w wymagania danego ogłoszenia, ale przede wszystkim stanowiska, spełniającego oczekiwania kandydata. Numer rejestru agencji zatrudnienia: 496.
We are currently seeking candidates for the position on behalf of our client, a leading international medical device manufacturer.
The Lead Monitor is responsible for the compliance and oversight of clinical trials that implement a Risk-Based Monitoring (RBM) strategy and being the main point of contact between the study team and site monitors. This role ensures that clinical trials are conducted in accordance with all applicable regulations, Good Clinical Practice (GCP), and company SOPS’s.
Key Responsibilities:
- Develop and execute monitoring plans through protocol analysis for remote risk management.
- Prepare for and conduct regular Site Compliance Meetings, reviewing KRI’s and any associated action items
- Ensure GCP compliance for monitoring clinical trials, including the implementation of future monitoring approaches.
- Evaluate the development of monitoring plans and employ efficient and accurate strategies for monitoring clinical trials.
- Collaborate with clinical KOLs and internal teams to manage clinical strategy.
- Utilize technology-enabled tools and risk evaluation approaches for remote monitoring.
- Provide training to monitoring team and support to site personnel to ensure high-quality data collection and regulatory compliance.
- Continually monitor data and analyse findings to decide whether to conduct a remote or targeted on-site monitoring visit.
- Review oversight of monitors and ensure adherence to service level agreements and legal and regulatory standards.
- Represent Site Management in Study Core team meetings
- Collaborate with Study team as needed for Audit response or Site Corrective Action Plan
Qualifications:
- Bachelor's degree in a related field
- Extensive experience in clinical research, particularly in monitoring clinical trials as LEAD Monitor.
- Strong Leadership skills: Ability to lead a team and work independently. Possesses good interpersonal skills, self-motivated, and retains a positive attitude. Ability to produce clinical trial deliverables within established timelines and budget.
- Strong analytical and problem-solving skills.
- Good planning, time management and prioritization skills
- Excellent communication and interpersonal skills.
