P95 finds, collects, analyzes 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 favorite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use.

P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.

The ideal candidate will  

• Share a passion for epidemiology and the drive to help our customers achieving their objectives 
• Have a Masters or PhD in Epidemiology and/or graduate from a recognised field epidemiology training program (e.g. EPIET, EIS,..). Specific training in infectious disease epidemiology, vaccine epidemiology and/or pharmacovigilance is a plus 
• Be fluent in spoken and written English 
• Have experience working as an epidemiologist, particularly in infectious diseases 

• Be able to work independently (remote), yet still in a team 
• Be sensitive to cross-cultural differences 
• Have good communication skills 
• Have a flexible approach to work 
• Be a self-starter, well organised and with attention to detail while keeping a “getting the job done” mentality. 

• Be focused on delivering high-quality results on time 

Do you want to join us? 

If you are the one for this job, send your application to jobs@p-95.com. Call will remain open until the position is filled. Only shortlisted candidates for interview will be contacted. 

Your CV is important but we are specifically looking for the right people for our team. Please write to us about why you would like to join us and how you see yourself contributing to P95 delivering Excellence in Epidemiology and Pharmacovigilance. 

P95 finds, collects, analyzes 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 favorite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use.

P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.

Job purpose
The Study Data Manager is responsible for managing data management activities in the design, administration, data collection and lock of database for post-market surveillance studies but also for other types of studies (e.g., epidemiological studies). The Study Data Manager will play a key role in the project team and interface with research collaborators providing data and external vendors to fulfill many of his/her responsibilities.

Responsibilities
The roles and responsibilities for the Study Data Manager include, but are not limited to, the following:

• leading the development of data management capacity within P95,
• serving as the Lead Data Manager on multiple studies,
• implementing and supervising data management activities within assigned studies,
• developing data and database specifications for studies, including electronic and/or paper Case Report Form (CRF) design, user requirements, edit rules/checks, query logic and data validations,
• responsibility for double-data entry of existing paper CRFs,
• creating and maintaining project data management documentations (Data Management Plan, ),
• participating in the review of study research documents (eg. protocols, CRFs, reports and statistical analyses),
• contributing to the design of electronic data capture (EDC) systems,
• extracting and monitoring study data to identify issues,
• ensuring that the data is of good quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- including e.g., data reconciliation,
• participating in the preparation and presentation of data, when applicable,
• ensuring data system compliance by following the established guidelines of national and international regulatory authorities,
• participating in conference calls and/or meetings with research collaborators providing data and vendors, and
• mentoring or training other team

Experience:

The ideal candidate will have

• a Bachelor of Science (BSc) degree or higher, preferably in Health Sciences, Statistics, Informatics,
• working knowledge of ICH Good Clinical Practice (GCP) guidelines, clinical research, Good Epidemiological Practice (GEP) and other guidelines and standards related to study data management,
• ≥5 years of professional experience in relevant data management activities in the CRO or medical device/pharmaceutical industry,
• experience in leading clinical data management activities on clinical trial level and managing as well as supervising external CROs/vendors,
• experience in electronic data capture (EDC) systems,
• experience in monitoring and supervision of the set-up and maintenance of CDMS systems, eTools like EDC and filing and archiving of trial documentation,
• applicable knowledge in querying databases (SAS, SQL, R, others),
• experience in creation and execution of data quality checks,
• knowledge of industry data standards (CDISC, SDTM, CDASH), and
• excellent organisational skills.

You must also have these skills

• You are fluent in spoken and written English.
• You can work independently (remotely) and yet be a team player.
• You have a flexible approach to work.
• You are a self-starter, well organised 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 have good communication skills.

What we offer
You will join a young, very dynamic, and fast-growing private research organisation. Our international, passionate, and diverse team consists of 60+ staff members, including epidemiologists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and office support staff spread over more than 10 countries. Our headquarters are in Leuven, Belgium but all our staff work remotely, setting their own time schedule, based on a “getting the job done” mentality. You may need to travel to our head office or to our client’s offices occasionally.

Working at P95 means an opportunity to work in a team on a project basis with ample room for professional development. We offer a lot of autonomy, flexibility and ample opportunities for research and development, to make things happen. We offer the opportunity to learn and evolve professionally. We consequently value self-reliance, initiative, and responsibility of everybody in our team to meet customer expectations. 

We offer you a full-time position. If you prefer a part-time job, we accept a minimum of 80% full-time equivalent (80% FTE).

For more information, contact our Head of Data Sciences, Kaatje Bollaerts: kaatje.bollaerts@p-95.com

P95 finds, collects, analyzes 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 favorite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use.

P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.

Job purpose
As Analytical Programmer, you will work with and support a team of epidemiologists, data analysts and statisticians.

Responsibilities
The roles and responsibilities for the Analytical Programmer include, but are not limited to, the following:

• developing analysis datasets,
• producing analysis tables and figures,
• developing macros and functions,
• performing quality control of study reports,
• writing statistical analysis plans,
• contributing to the development of scientific publications based on the analyses and study results, and
• conducting the statistical analyses for epidemiological and pharmaco-epidemiological studies.

Experience

The ideal candidate will

• have at minimum a master’s degree in statistics, data science, or computer science or equivalent professional experience,
• have experience with statistical programming (a proficient level of expertise is required in either SAS or R),
• be able to produce statistical tables and figures in a rigourous and efficient manner,
• have previous experience in working with large databases (knowledge of database-specific languages such as SQL will be considered a plus), and
• have a keen eye for detail and good communication skills.

You must also have these skills

• You have good command of written and spoken professional English.
• You can work independently (remotely) and yet be a team player.
• You have a flexible approach to work.
• You are a self-starter, well organised 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.

What we offer
You will join a young, very dynamic, and fast-growing private research organisation. Our international, passionate, and diverse team consists of 60+ staff including epidemiologists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and office support staff spread over more than 10 countries. Our headquarters are in Leuven, Belgium but all our staff work remotely, setting their own time schedule, based on a “getting the job done” mentality. You may need to travel to our head office or to our client’s offices occasionally. 

Working at P95 means an opportunity to work in a team on a project basis with ample room for professional development. We offer a lot of autonomy, flexibility and ample opportunities for research and development, to make things happen. We offer the opportunity to learn and evolve professionally. We consequently value self-reliance, initiative, and responsibility of everybody in our team to meet customer expectations. 

We offer you a full-time position. If you prefer a part-time job, we accept a minimum of 80% full-time equivalent (80% FTE).  

For more information, contact Head of Data Sciences Kaatje Bollaerts: kaatje.bollaerts@p-95.com

P95 finds, collects, analyzes 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 favorite global partner in the field of epidemiological research and pharmacovigilance, in support of vaccine development and use.

P95 offers a broad range of services in Epidemiology, Pharmacovigilance, Data Analytics, IT services, Medical Writing and Training.

Job purpose
The Project Manager works across project teams and supports P95 in ensuring that projects (e.g., observational studies) deliver as expected regarding scope, quality, time, and budget. The Project Manager will play a key role in project teams and interfaces with both internal colleagues and external collaborators to fulfil many of his/her responsibilities.

Responsibilities
The roles and responsibilities for the Project Manager include, but are not limited to, the following:

• leading the study start-up process including project kick-off meeting and the set-up of a suitable system for all required study documentation,
• chairing all project progress meetings, ensuring meeting minutes are completed and distributed to all team members,
• being the focal point of contact for the client and all study partners,
• participating in and organising study investigator meetings and study site visits as required,
• identifying risks and problems and developing effective ways to solve them as a team, escalating where necessary,
• driving effective cross-functional teamwork among the project team members,
• developing a project-specific project management plan in collaboration with the project team members,
• measuring project performance using appropriate systems, tools, and techniques,
• creating and maintaining comprehensive project documentation as required by the client and regulations, as applicable,
• providing project progress reports to the client, at the agreed frequency,
• overseeing and managing study feasibility and study site monitoring performance, and
• developing and maintaining optimal study site relationships with the key investigator sites and alliance partners.

Experience

The ideal candidate will

• have a university degree, preferably in science/life sciences,
• have a good understanding of health research projects,
• have a minimum of 2 years experience in project management of multi-country health research projects, ideally within an international context,
• have project management qualifications (certification is an asset),
• have proficiency in MS Office and experience using project management software,
• have experience in coordinating remote teams,
• be able to think analytically and have good communication skills,
• be inquisitive and wanting to contribute to the development of an innovative company, and
• be able to travel internationally up to 10% of the time.

You must also have these skills

• You are fluent in spoken and written English, and if you are knowledgeable in other languages, this is an asset.
• You can work independently (remotely) and yet be a team player.
• You have a flexible approach to work.
• You are a self-starter, well organised 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.

What we offer
You will join a young, very dynamic, and fast-growing private research organisation. Our international, passionate, and diverse team consists of 60+ staff including epidemiologists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and office support staff spread over more than 10 countries. Our headquarters are in Leuven, Belgium but all our staff work remotely, setting their own time schedule, based on a “getting the job done” mentality. You may need to travel to our head office or to our client’s offices occasionally. 

Working at P95 means an opportunity to work in a team on a project basis with ample room for professional development. We offer a lot of autonomy, flexibility and ample opportunities for research and development, to make things happen. We offer the opportunity to learn and evolve professionally. We consequently value self-reliance, initiative, and responsibility of everybody in our team to meet customer expectations. 

We offer you a full-time position. If you prefer a part-time job, we accept a minimum of 80% full-time equivalent (80% FTE).  

For more information, contact Project Manager Griet Rebry: Griet.Rebry@p-95.com