- Michała Bobrzyńskiego 14, 30-348 Kraków-Podgórze, PolskaKraków, małopolskie
- Ogłoszenie wygasło 20 dni temu
- Umowa o pracę
- Pełny etat
- Kierownik / Koordynator
As Study Manager you will be in charge of clinical deliverables within the study specified time and you will ensure efficiency of clinical activities. Additionally with cooperation with Director of Study Management and Quality Assurance you will be responsible for managing vendors and outsourced services.
We are looking for an Individual with clinical project management experience within oncology therapeutic area who would like to become a part of Clinical Team in biotech organization and contribute to development of current study and future ones.
- Responsible for timely set up, organization, content and quality of the relevant sections of the Trial Master File; responsible for the implementation and training of standardized clinical monitoring processes within the study and the timely archiving of documents and study materials for the clinical department
- Prepares and monitors clinical activity timelines and metrics; ensures regular project review, and reviews monitoring visit reports
- Manages CRF collection and query resolution process as needed; co-monitors clinical trials as needed and assesses performance and/or ensures contractual obligations are met
- Coordinate all start up activities and ensures that timely EC and Regulatory submissions are addressed
- Ensures that essential document quality meets the expectation of regulatory requirements.
- In conjunction with the Director of Study Management prepares, organizes and presents at the internal company meetings and Investigator Meetings.
- Manages the vendors through documented performance and issue management; escalates to Director if Study Management any project risks or unresolved issues
- Drive timeline and deliverable management of all vendors activities
- Check with the study team to ensure changes to protocol, allocation or other study designs are consistently shared and incorporated into supplier budgets, timelines, and specifications
- Oversee vendor issue management; escalate issues that could present a risk to the patient safety, validity/integrity of data, regulatory acceptance and/or to Ryvu business reputation in timely manner in accordance to relevant procedures
- Responsible for ensuring vendor compliance with Ryvu/contracted CRO SOPs and business guidance; responsible, in partnership with QA, to document trial level deviations and perform Root Cause Analysis for process improvement
- As required create appropriate training for study team members and vendors
- At least BSc degree in health care or life sciences field
- Minimum 2-3 year experience in clinical projects management (pharma/biotech or CRO), Must have experience in oncology trials in patients. Phase I experience is a plus.
- Current GCP certificate
- Proficient level of English
- Adequate knowledge of relevant regulations, eg ICH/GCP, FDA guidelines, etc
- Openness to travels: up to 20-30%, mainly locally or in EU, rarely USA
- Represent strong organizational, problem solving, decision making skills
- Good computer literacy (including Microsoft Office and MS project)
What we offer:
- Competitive base salary and bonus opportunities
- Private medical care
- Life insuarance
- Training programs: internal scientific, lectures, expert and peer coaching
- Language lessons in English or Polish
- Conference attendance sponsorship
- MultiSport Card
- Volleyball and Football teams
- Lunch benefits and fruits in the office
We kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Ryvu Therapeutics SA for the purpose of existing recruitment process”. If you want us to keep the submitted documents also for the purposes of future recruitment processes, we kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Ryvu Therapeutics SA for the purpose of future recruitment processes for a period of 3 years from the date of submission of this document, in order to analyze them in terms of the recruitment processes carried out in the Ryvu Therapeutics SA”