Study Manager in Homeoffice bei P95

P95 finds, collects, analyses and reports epidemiological data to assist public health agencies, research organizations and pharmaceutical companies in improving peoples´ access to safe and effective vaccines.
Our vision is to be the world’s favourite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use. We are continuously looking for nice, enthusiastic, and smart people.
P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.

As a Study Manager, you will work across project teams and support P95 in ensuring that projects (eg. observational studies) are delivered as expected regarding scope, quality, timeline and budget. You will play a key role in project teams and interfaces with both internal colleagues and external collaborators to fulfil your responsibilities.

• Lead the study start-up process including project kick-off meetings and the set-up of a suitable system for all required study documentation
• Chair all project progress meetings, ensuring meeting minutes are completed and distributed to all team members
• Act as the focal point of contact for the client and all study partners
• Participate in and organize study investigator meetings and study site visits as required
• Identify risks and problems and develop effective ways to solve them as a team, escalating where necessary
• Drive effective cross-functional teamwork among the project team members
• Develop a project-specific project management plan in collaboration with the project team members
• Measure and monitor project performance using appropriate systems, tools and techniques
• Create and maintain comprehensive project documentation as required by the client and regulations, as applicable
• Provide project progress reports to the client, at the agreed frequency
• Oversee and manage study feasibility and study site monitoring performance
• Develop and maintain optimal study site relationships with the key investigator sites and alliance partners

• Have a university degree, preferably in science/life sciences
• Have a good understanding of health research projects
• Have a minimum of 2 years of experience in study management of multi-country health research projects, ideally within an international context
• Have project management qualifications (certification is an asset)
• Are proficient in MS Office
• Have experience in coordinating remote teams

• You are fluent in written and spoken professional English
• You have the ability to think analytically with excellent communication skills
• You are inquisitive and wanting to contribute to the development of an innovative company
• You can work independently (and remotely) and yet be a team player
• You have a flexible approach to work
• You are a self-starter, well organized and with attention to detail while keeping a “getting the job done” mentality
• You are focused on delivering high-quality results on time
• You are sensitive to cross-cultural differences
• You are available to travel internationally up to 10% of the time

You will join a young, very dynamic, and fast-growing private research organization. Our passionate, truly multicultural, and diverse team of more than 115 colleagues and nearly 40 nationalities include epidemiologists, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and business support professionals spreading over 20 countries.

We all work remotely, setting our own time schedule, based on a “getting the job done” mentality. This has a positive impact in our work-life balance. Our headquarters are in Leuven (Belgium), but we also have local and regional offices located in Rotterdam (the Netherlands), Bogota (Colombia) and Bangkok (Thailand). You may need to travel occasionally to one of our offices or to our clients’ offices.

At P95, we are a collaborative and international team that works on diverse projects, topics, and clients and faces interesting challenges. There is a high level of empowerment, flexibility, autonomy as well as opportunities for research and development, to make things happe