Senior Clinical Trial Manager
Wien, AT
About HOOKIPA:
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures for HBV and HIV in collaboration with Gilead.
Position Summary:
The Senior Clinical Trial Manager is responsible for overseeing and managing the operational aspects of clinical trials (incl. budget). Responsibility in planning, implementation, and execution of clinical trials and for ensuring that the trials are conducted according to the protocol, standard operating procedures, good clinical practices, and applicable regulations.
Main Responsibilities:
- Understanding the requirements of the various ethical and regulatory bodies, agencies and frameworks, guiding the study in conforming to those requirements and coordinating any necessary audit processes.
- Leading with the recruitment, training, appraisal, retention, and supervision of study team members.
- Responsible for budget for specific clinical trial and study related supplies
- Coordinating applications, and subsequent amendments as applicable, to ethical and regulatory bodies.
- Performing site visits to facilitate study set up and initiation, regular monitoring visits during patient recruitment, and close out visits on study completion.
- Regularly liaising with study sites and other members of the core team (data managers, statisticians, epidemiologists) to ensure follow-up visits data are kept up-to-date, accurately completed and that loss of patient data is kept to a minimum.
- Ensuring the timely recruitment of study participants with secure randomization processes and subsequent efficient and effective data management.
- Ensuring that all study adverse events are appropriately investigated by the study staff and accurately reported to the investigator and regulatory bodies as required.
- Monitoring study progress to ensure compliance with and adherence to the study plan and to identify, evaluate and rectify problems.
- Supporting investigators in the collection and monitoring of study data and to liaise with collaborators, study doctors and the data manager to ensure that follow-up information is kept up-to-date, accurately completed and that loss of patient data is kept to a minimum.
- Ensuring the inclusion of patients and public involvement and engagement group representatives at the appropriate levels and times.
- Acting as the first point of contact for all external and internal agencies
Qualifications & Skills:
- Several years of professional experience in clinical research and the management of (international) clinical trials, with emphasis on the management of early phase (phase I-III) oncology studies
- Sound knowledge, EMA and ICH / GCP regulations and guidelines, FDA is a plus
- Solid background in oncology and strong interest in new therapies
- Independent, communicative, proactive, goal-oriented and reliable work approach
- Fluent in German and English, both written and spoken
- Willingness to travel
What we offer:
- Strong team with dedicated and passionate researchers
- State of the art infrastructure
- Excellent working atmosphere
- Opportunities for personal development
- Employee benefits such as health screening, public transportation card, Sodexo pass
- Working in a multinational and multicultural environment
- Flexible Working Hours
- After training phase: home-office possibility up to 40% of working time
We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 5.000 based on fulltime (40 hours per week, 14 monthly installments); depending on experience and qualification the salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
Starting date: As soon as possible
Contact:
If you are interested in this challenging position, please send us your CV including a cover letter (summarizing your qualification and experiences) together with your credentials.
For more information on HOOKIPA please visit www.hookipapharma.com