- Erazma Ciołka 10, 01-402 Warszawa, PolskaWarszawa, mazowieckie
- Ogłoszenie wygasło miesiąc temu
- Rekrutacja zdalna
- Umowa o pracę
- Pełny etat
- Kierownik / Koordynator
As a global Contract Research Organization with 15 years of experience, Clinscience is growing at a fast pace both organically and via acquisitions. We combine the knowledge and experience of medical, biostatistics, regulatory and clinical operations experts, to effectively conduct the end to end clinical research processes. Clinscience CRO is part of Neuca Group, the public healthcare company listed on the Stock Exchange focused on developing patient-centric businesses. We are focused on technology and having the patient at the center of our interest and operations. At Clinscience, you really can make a difference and we are committed to providing the very best career development opportunities that encourage you to progress in the direction of your strengths and aspirations. Whether you’re looking to develop your technical expertise, project leadership or line management skills, we work with you to help you achieve your goals.
Clinscience is currently looking for a person for the position of:
- acting as a first contact point for the Client in area of assigned project related responsibilities, establishing and maintaining good working relationship, and ensuring Client satisfaction;
- managing realization of international clinical trials projects and leading assigned project teams;
- ensuring that clinical trials are conducted in compliance with the study protocol, contractual agreements and with the highest quality at all levels of project implementation;
- ensuring the smooth communication within all parties involved in the project execution;
- assisting in identifying resources needed for assigned studies as per the respective contract with the Client;
- managing process of the project budget preparation, and later its maintenance and closure;
- managing processes of preparation and review all study-specific documents including but not limited to protocols, ICFs, CRFs, project plans, and CSRs;
- collecting and analyzing data from the project team (both- internal and external) in order to develop, maintains, and update Clinscience Key Performance tools, and evaluating completed metric data to (if needed) recommend process improvements and mitigation strategies to the Sponsor;
- reviewing and approving MVRs;
- cooperation with the project team, Investigators, Clients, suppliers and the NEUCA Group.
- minimum 1 year of experience in independent managing international clinical trial projects, and at least 5 years of relevant clinical research related experience in a pharmaceutical company/ CRO
- knowledge of the ICH-GCP and ISO 14155:2020 guidelines;
- knowledge of EMA, FDA regulations;
- knowledge of local regulations regarding clinical trials;
- fluent English, both spoken and written;
- excellent communication, interpersonal, planning & organization skills;
- good computer skills with good working knowledge of a range of computer programs;
- ability to communicate, negotiate and liaise with Clients in a professional manner.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We offer job for full FTE.
If you are interested in this position, please apply.