SUMMARY
Pharvaris - a clinical-stage company focused on bringing an oral bradykinin B2 receptor antagonist to patients - is seeking a highly motivated Clinical Trial Manager to join and provide assistance to the Clinical Team, providing support on multiple administrative and operational activities throughout study lifecycles.
This position is within a highly collaborative and international department that strives to achieve high quality and excellent results. This role will be based in Leiden, the heart of biotech in The Netherlands and reports to the Head of Clinical Operations, who is based in Massachusetts, USA. We offer talented staff a great working environment, dedicated and driven co-workers, short lines of communications and an attractive compensation package. We may start the relationship with a one-year contract with the intention to renew or convert to permanent.
KEY DUTIES AND RESPONSIBILITIES
- Ensure proper conduct of clinical trials in accordance with the Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pharvaris standards to achieve project goals, timelines and quality
- Provide input to or develop study-related materials such as study plans & guidelines, recruitment materials, and patient informed consents
- Identify, evaluate and select investigator sites as needed
- Liaise or manage external vendors (e.g. laboratories) as needed
- Interface with the study team; facilitate information flow between members of the study team, vendors and assigned investigator sites
- Oversee investigator site activation activities, including Green Light Package completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation
- Support study team as needed with Regulatory, Central, and Local Ethics Submissions and responses
- Attend investigator meeting when required and develop/conduct investigator meeting presentations and/or trainings as required
- Provide enrolment support to and ensure progress by responding to site staff issues
- Track all required reports, documentation, updates within required timeframes, including but not limited to Trial Master File documentation, monitoring visit reports, site visit follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
- Support clinical database release, SAE reconciliation, and resolution of data queries within required timelines
- Conduct onsite, remote/electronic (co-)monitoring as needed for study site initiation, routine monitoring and study site closure visits with or without CRO CRAs as needed
- Proactively identify, manage and escalate site issues
- In collaboration with appropriate study team members, identify study quality issues and assist with creation and implementation of corrective actions and preventative actions (CAPA) as needed
- Assist/develop site communications, including but not limited to letters/memos, slide presentations, study newsletters
- Train internal team members as assigned
Qualifications:
- Degree in (bio)medical/pharmaceutical sciences, MSc preferred
- Requires a minimum of two years of related experience in clinical trial operations
- Experience in Biotech/Pharmaceutical industry preferred
Personal & Professional Skills:
- Knowledgeable in GCP and ICH requirements
- Understanding of clinical trial methodology and operations
- Experience in site monitoring as a CRA is preferred
- Ability to organize and prioritize several tasks and complete them under time constraints
- Able and willing to work flexible hours including evening hours as needed, due to clinical operations in different timezones
- Result oriented and proactive attitude with a can-do mentality. High standards, self-starter.
- Open-minded and creative problem solver who is punctual, takes ownership, and can deal with competing priorities and challenges.
- Excellent interpersonal, oral and written communication skills in English
Interested?
If you are interested to be part of a great and dedicated team at Pharvaris, please send your full resume and application letter to our HR department, . If you need in-depth information about the role of Clinical Trial Manager, Simone van Leeuwen, MSc, Senior Clinical Trial Manager at Pharvaris is happy to answer your questions. Please email Simone at