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Global Data Manager Specialist - Project GIFTS
Requisition ID: 1805642511W
GLOBAL DATA MANAGER Specialist (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
- 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 IDS 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 IDS 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 IDS.
- Presents information and trains investigator and site monitors.
- Integrity & Credo-based Actions
- Results & Performance Driven
- Sense of Urgency
- Strategic Thinking
- Big Picture Orientation
- Intellectual Curiosity
- Prudent Risk Taking
- Organization & Talent Development
- Collaboration & Teaming
- Self Awareness & Adaptability
- A minimum of a BS/BA degree or professional experience equivalent.
- Data Management experience
- 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.
- Vendor Oversight experience
- Team Leadership experience
- PM experience
- Experience as a Snr GDM
- 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