Project Leader for Clinical Trial SaaS Application, Implementation and Validation

The Swiss Tropical and Public Health Institute (Swiss TPH) is a world-leading institute in global health with a particular focus on low- and middle-income countries. Associated with the University of Basel, Swiss TPH combines research, services, education and training at the local, national and international level. Over 850 people from more than 80 nations work at Swiss TPH focusing on infectious and non-communicable diseases, environment, society and health as well as health systems and interventions.

Our Clinical Operations Unit is specialized in the conduct of clinical trials for poverty-related diseases in resource-limited settings. An exciting opportunity has arisen for an enthusiastic and motivated individual to work alongside our team, lead digitalization and enable us to be more agile and fit for the future as:

We are looking for a self-motivated, trustworthy and reliable individual to drive and implement successfully a new e-clinical software solution including the necessary validation activities. The post-holder will have a key role in facilitating research delivery, operations and the smooth running of our department, which contributes in driving sustainable growth, maintaining research efficiency and subjects' safety. The ideal candidate will have outstanding organizational skills, be a quick learner, competent in prioritizing and taking initiative, an excellent communicator with high level of social competence and the ability to work effectively within a team.

This is a great opportunity to work in a clinical research operational environment with experienced staff, providing an opportunity to develop knowledge and drive clinical research in a non-profit setting and low-income countries. This position is available immediately.

Your position

• Drive the validation of a Software as a Service (SaaS) based Clinical Trials application suite with Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) modules
• Develop, coordinate and write Standard Operating Procedures (SOPs) to successfully validate and implement this new application
• Actively participate in the definition of the required processes and evaluation of standard practices and procedures within the Clinical Operations Unit
• Ensure the timely validation, implementation and go-live of the Clinical Trials application suite
• Promote audit readiness
• Work closely with the operational team to optimize our operational environment
• To support in a second instance the acquisition and validation of other GxP relevant software such as QMS and eDC
• Act as a central contact for the clinical/operational team for designated SOP/Guideline related communications
• Act as an interface between the Quality Management team, the operational team and Vendors

Your profile

• Experience in validation of GxP systems according to GAMP including writing validation documents (e.g. Validation Plan, User Requirements Specifications, Risk Assessment) and SOPs
• Knowledge of Good Clinical Practice (ICH-GCP) guidelines and applicable regulations
• Relevant experience with Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO), electronic Clinical Outcome Assessment (eCOA) systems or other related clinical software
• Software as a Service (SaaS) experience with special focus on validation topics
• Understanding and familiarity with IT (IT background or affinity) and scientific terminology, regulatory and plain language
• Excellent organizational skills with attention to detail and prioritization skills
• Ability to communicate instructions that are concise and increase the users' understanding of tasks in general and validation topics in particular more easily
• Ability to work independently and take ownership
• Flexibility and ability to work under pressure
• Team player with outstanding communication skills, willingness to learn and lead by example
• Interest in projects in resource limited countries
• Fluent in English. French and German is an asset.

• Life-science or computer science-related degree
• Industry background
• Exposure and experience with patient facing situation and/or good understanding of the clinical context
• Exposure to low income settings
• Exposure or experience in audit or inspections of SaaS applications

We offer you

The core team is based in Basel, Switzerland, but the wider team across Europe and Africa. The successful applicant will receive a one-year contract in the first instance.

Swiss TPH is an equal opportunity employer committed to excellence through diversity.