Clinical Project Manager
Exscientia, Austria
Job Description
We are looking for a highly motivated Clinical Project Manager to join our Clinical Operations team. As Clinical Project Manager you will facilitate the expansion of our global biospecimen collection efforts as well as clinical evaluation of our functional precision medicineplatform (see Kornauth et al., Cancer Discovery 2021) that are at the core of our patient first AI approach to drug discovery. You will do this through the set up and management of international multi-centric clinical studies and will make sure that internal and external regulations, as well as legal requirements are met. You will coordinate multiple stakeholders but also take on hands-on operational tasks to ensure efficient study execution and success.
Exscientia is an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia also developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study. Preclinically, our platform enables us to test the activity of potential drug candidates directly in live human tumour tissues to get patient relevant insight into their activity prior to commencing clinical studies. This allows us to bring the patient into the preclinics and select the most promising molecules for first in human trials to maximise our chances of clinical success.
Our pipeline demonstrates our ability to rapidly translate scientific concepts into precision-designed therapeutic candidates, with more than 25 projects underway. By designing better drugs, faster, we believe the best ideas of science can rapidly become the best medicines for patients.
- Plan, organise, and direct activities of personnel involved in national and international clinical research projects (CRAs, providers, etc.) to ensure that general clinical goals and objectives are met
- Monitor, track and report on the progress of delegated clinical studies and tissue collections, including management of all aspects of clinical studies, budgets and timelines
- Review of interactions and discussions with physicians to assess and ascertain the correct conduct of clinical studies on site
- Selection and validation of vendors to guarantee the safety of patients, while adhering to contractual agreements, procedures, and data integrity
- Take on the role of key contact for KOLs amp; vendors, as well as internal departments and diverse study teams to ensure that trials are conducted and executed effectively, and in line with company goals
- Author, prepare and review key clinical study documents including protocols, manuals, contracts, vendor budgets, and annual reports
- Support building and maintenance of our quality management system for the Clinical Operations Department
Requirements
- University degree in a life science field or an equivalent combination of education, training and experience
- Min. 5 years of experience as a CPM and previously as a CRA/Monitor in a CRO/medical device or pharmaceutical company, with experience in clinical research
- In-depth knowledge and understanding of ICH/GCP
- Knowledge and understanding of ethical and regulatory requirements (EU)
- Experience drafting and handing in submissions to regulatory authorities and ethics committees
- Excellent written and spoken English skills
- Good understanding of EU GDPR requirements
Benefits
- Work together to make a positive contribution to patients by revolutionising the pharmaceutical industry through AI-driven discovery.
- We will work with you to kick-start or further grow your career from funding for professional development and conference attendance. To also ensuring you will have the opportunity to acquire valuable skills, work on problems that matter, and learn from world-class technical and scientific leaders.
- Opportunity to join an inclusive, collaborative and intellectually stimulating culture
- A highly competitive compensation package in accordance with the Austrian collective bargaining agreement, starting from a minimum of 45.000,- gross per year. We will negotiate an attractive package and overpayment based on your background and previous work experience.
- Our team’s health and well-being is important to us we offer a generous holiday allowance, provide flexible working and remote working to encourage all of our team to manage their own work, time and life along with wellbeing and mindfulness support.
- We offer daily lunch, regular team events and lots of opportunities for casual networking.
- Hear from our team why they enjoy working here