- Develop and design clinical trial protocols (Phase III) in collaboration with cross-functional teams and Contract Research Organizations (CROs), ensuring they adhere to regulatory guidelines, ethical standards, and study objectives.
- Oversee the operational aspects of clinical trials, including site selection, investigator training, site initiation, monitoring, and close-out activities.
- Ensure compliance with Good Clinical Practice (GCP) guidelines, relevant regulations, and study protocols throughout the entire trial process.
- Collaborate with internal teams and external stakeholders to establish timelines, budgets, and resource requirements for clinical trials.
- Manage relationships with clinical investigators, study coordinators, and other site personnel, providing guidance and support as needed.
- Conduct ongoing monitoring and evaluation of trial progress, identifying and addressing any issues or risks that may impact study timelines or data quality.
- Perform data analysis and interpretation, contribute to the development of study reports, and communicate trial results to stakeholders.
- Stay up-to-date with industry trends, advancements in clinical research methodologies, and regulatory changes to ensure best practices and compliance.
- Contribute to the development and improvement of standard operating procedures (SOPs), study protocols, and other relevant documentation.
experience - 3-5 years of experience working in clinical trials management or a related field within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
qualifications - 3-5 years of experience working in clinical trials management or a related field within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
- Strong knowledge of clinical trial processes, regulatory requirements, and GCP guidelines.
- Familiarity with relevant regulatory bodies (e.g., FDA, EMA) and their respective guidelines and regulations.
- Proficiency in study design, protocol development, and clinical trial execution.
- Excellent project management skills, with the ability to effectively prioritize tasks, manage timelines, and coordinate cross-functional teams.
- Experience in managing multiple clinical trials simultaneously, including monitoring study progress and ensuring adherence to timelines.
- Strong analytical and problem-solving skills, with the ability to identify and address issues proactively.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
- Detail-oriented mindset with a focus on data accuracy and quality.
- Advanced knowledge of data analysis and interpretation.
- Bachelor's degree in a relevant scientific field (advanced degree preferred).
-
Marine Surveyor
Βρέθηκε σε: beBee S2 GR - πριν 5 μέρες
RINA Piraeus, ΕλλάδαRINA is currently recruiting for a Marine Surveyor to join its office in Piraeus within the Marine South East Europe & MEA Region Division. · Mission · A surveyor in a classification society plays a crucial role in ensuring the safety, compliance, and quality of ships and marine ...
Clinical Trials Expert - Paiania, Ελλάδα - Randstad Hellas
Περιγραφή
Are you an experienced Clinical Trials Expert, with interest to work for a big pharmaceutical company? If you are a Clinical Trials Expert, ready to take the next step in your career, we have the ideal job for you.
Our client is looking for a highly knowledgeable and experienced Clinical Trials Expert to join their R&D team. The Clinical Trials Expert will be reporting to the R&D Director. Ηe/she will play a vital role in the planning, implementation, and management of clinical trials. The candidate's expertise in clinical research methodologies, regulatory compliance, and trial oversight will contribute to the successful execution of clinical trials and the generation of high-quality data.
key responsibilities
