Global Data Manager Specialist

"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo CLICK HERE TO GET TO KNOW MORE ABOUT LIFE @ Johnson & Johnson Global Data Manager Specialist At Actelion Pharmaceuticals, a member of the Johnson & Johnson Family of Companies, we are currently recruiting for a Global Data Manager (GDM) Specialist in Neuroscience. This position is primarily located in Allschwil, Switzerland, but may be in High Wycombe in the UK, Beerse in Belgium or Leiden in the Netherlands. The Global Data Manager Specialist provides oversite and accountibility for multiple low, moderate, and high complexity trials. This position makes recommendations and decisions that have an impact on specific trials or assignments. The GDM Specialist makes decisions for processes, timing, and structure for trials and assignments. This position makes recommendations for processes, timing, structure, and resources at a program level. Tasks & Responsibilities: Takes a leadership role with the CRO, the trial customer(s), GDM and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s). Identifies and communicates ways to improve deliverables. With the trial customer, CRO, GDM, and other functional partners: Takes a leadership role to gather content and integration requirements for eCRF and other data collection tools. Leads conventions and quality expectations for clinical data. Leads expectations for dataset content and structure. Sets timeline and follow-up regularly to ensure delivery of all data management milestones. Ensures trial level oversight controls are performed as described in the oversight plan, QC process, and work instructions. Ensures that clinical data management documents are reviewed accurately (including submission package) to facilitate appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix. Oversees the assessment of real-time inspection readiness of all DM deliverables for the trial. Participates in regulatory agency and J&J internal audits as necessary. Leads the planning and tracking of content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time. Takes a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are met. Collaborates with the DML to develop scope of work and identify needed resources. Works with Infrastructure Organization to ensure all deliverables are effectively completed. Takes a leadership role to obtain and share best practices with internal partners. Leads others in implementing process, system, and tool improvement initiatives within DM. Presents information and trains investigator and site monitors. May undertake the principal responsibilities of a CDM, as appropriate. Qualifications Required Bachelor’s degree or equivalent relevant education or experience. Data Management experience of 4-6 years Experience in clinical drug development within the pharmaceutical or related industry. Vendor oversight experience Team leadership experience. Project management experience. Preferred 2 years of experience in Neuroscience. 3 years of experience as a Senior Global Data Manager. Our offer: An exciting position in an international and dynamic environment with continuous learning and growth opportunities A competitive salary, on-site sport accommodations, health/energy programs and other benefits for you and your family. An inclusive team environment where diversity and different opinions are respected and valued, and the importance of a good work-life balance is recognized. If you are interested in working for a globally leading health care company in a challenging role, then send us your application in English today! We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location Switzerland-Allschwil-- Organization Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542) Job Function R&D Requisition ID 2206038410W