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Global Data Manager - Project GIFTS
Requisition ID: 1805642482W
GLOBAL DATA MANAGER (GIFTs)
Location: UK, High Wycombe
Full time permanent contract
The Pharmaceutical sector of Johnson & Johnson is now looking for a Senior Global Data Manager:
At Janssen, part of Johnson & Johnson, Family of Companies, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information
- Works with CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations to the business for assigned trial(s).
- With the trial customer, CRO and other functional partners:
- Gathers content and integration requirements for eCRF and other data collection tools.
- Participates in establishing conventions and quality expectations for clinical data.
- Participates in establishing expectations for dataset content and structure.
- Works with others to set timelines and follows-up regularly to monitor delivery of all data management milestones.
- Performs trial level oversight controls as described in the oversight plan, QC process, and work instructions, with DML direction.
- Reviews clinical data management documents (including submission package) for appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Works with DML to facilitate compliance with regulatory guidelines and the documentation matrix.
- Works with DML to facilitate real-time inspection readiness of all IDS deliverables for the trial. Participates in regulatory agency inspections and J&J internal audits as necessary.
- Works with DML to plan and track 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. Works with DML to ensure deliverables are on time.
- Supports the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met.
- Identifies and communicates lessons learned with support from DML and frequently asked questions at trial level.
- Participates in process, system, and tool improvement initiatives within IDS.
- Presents at investigator and monitor meetings.
- A minimum of a BS/BA degree or professional experience equivalent.
- Experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
- Experience in clinical drug development within the pharmaceutical industry or related industry.
- A challenging and a very interesting job in one of the biggest global pharmaceutical companies
- An opportunity to make an impact with your actions
- An opportunity to help others develop further and improve in their daily tasks
- Possibilities for own further development and growth
- Many opportunities to participate on different projects and drive Janssen’s growth further
- Motivating remuneration and many employee benefits
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)
Clinical Data Management