Clinical Data Manager

Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and to customer satisfaction. Provide comprehensive data management expertise to the Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; communications; and milestone deliverables.The responsibilities for the Data Manager include, but are not limited to, the following:

• Write and maintain Data Management documentation: Data Management Plan, Data Management Report, Data Cleaning Plan...
• Send the Data Clarification Forms/queries to clinical sites and ensure that clinical data has been updated
• Define and perform Database Edit Checks/data cleaning
• Manage the upload of external data
• Perform medical coding
• Conduct the reconciliation of SAEs
• Manage protocol deviations
• Lock the clinical database (interim and/or final lock)
• 3 – 5 years of DM experience with a minimum of 1 year’s direct sponsor management.
• Knowledge of the clinical trial process, Data Management, Clinical Operations, Biometrics, and system applications.
• University / College degree (life sciences, health sciences, information technology or related subjects preferred)
• Experience and/or education plus relevant work experience, equating to a bachelor’s degree will be accepted in lieu of a bachelor’s degree.
• Good communication skills in English, both written and verbal
• Demonstrated technical abilities and skills in the use and management of computer databases
• Experience with ENNOV Clinical EDC system, knowledge of CDISC and knowledge of SDTM are pluses
• You can work independently (and remotely) and yet be a great team player
• You can work on diverse projects in various disease areas simultaneously
• You have a flexible approach to work
• You are well organized and with attention to detail while keeping a “getting the job done” mentality
• You are sensitive to cross-cultural differences
• You have a keen eye for detail You will join a young, very dynamic, and fast-growing private research organization. Our passionate, truly multicultural, and diverse team of more than 200 colleagues and nearly 40 nationalities include epidemiologists, clinical operations, CRAs, CTAs, 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), Johannesburg (South Africa), Bangkok (Thailand), Paris (France) and Durham (United States). You may need to travel occasionally.

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 happen. We have an open culture of respect and inclusion. Consequently, we value self-reliance, initiative, and responsibility of everyone in our team to meet our internal and external customers’ expectations. Finally, our colleagues experience a strong sense of meaning and purpose driven by the scientific nature and impact of our work.Visit our website www.p-95.com to learn more about who we are and what we do. If you are the one for this job, send your application by filling out the following short form. The call will remain open until the position is filled.
P95 is an Equal Opportunities Employer. The company is committed to equal employment opportunities regardless of age, sexual orientation, gender, pregnancy, religion or belief, union belief, wealth, birth, nationality, ethnic origin, disability, medical history, skin color, marital status, genetic information, parental status, social origin, or condition. We base all our employment decisions on merit, job requirements and business needs.