Clinical Data Manager (remote, full-time)

at  P95

EXPERIENCE - THE IDEAL CANDIDATE WILL HAVE

• 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

EXPERIENCE - YOU MUST ALSO HAVE THESE SKILLS

• 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

ABOUT US

P95, an Ampersand portfolio company, is a global provider of clinical and epidemiological services related to vaccines and infectious diseases.
Founded in 2011, we are a leader in sourcing, analyzing, and reporting epidemiological data to assist health agencies and pharmaceutical companies in improving access to safe and effective vaccines.
Headquartered in Belgium, P95 has also offices in Europe, North America, South America, South Africa, and SE Asia.
We are passionate about healthcare and helping our customers with innovative medical research. We share a sense of urgency with our customers to deliver timely, pragmatic and useful insights to improve healthcare.
Our clients are from the pharmaceutical industry, public health institutes, academic institutions, WHO, the European Commission and other governmental organizations and Non-Governmental Organizations (NGOs). Our projects focus mainly on infectious diseases, particularly on vaccines

JOB PURPOSE

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.

RESPONSIBILITIES

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)