Global Data Manager Specialist

仕事内容

Location: Beerse, Belgium or Allschwill, Switzerland

Working with Johnson & Johnson can change everything. Including YOU.

We are recruiting a Global Data Manager Specialist within our Integrated Data Analytics and Reporting Department under the Neuroscience therapeutic area. The candidate can be based out of Beerse, Belgium or Allschwill, Switzerland ! Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are looking for a professional individual contributor that provides oversight and accountability for multiple moderate and high complexity trials. The GDM Specialist mentors and coaches GDMs and Senior GDMs on trial level responsibilities and may delegate work to them. You may also be a lead of a process improvement and innovative project. This position analyzes, gives recommendations, and makes data management related decisions with minimal direction from a Data Management Leader (DML).

The desired candidate must have a good understanding of current clinical drug development processes. A GDM Specialist must also have knowledge of applicable international guidelines regarding for end to end clinical trials. Relevant system and technical knowledge is especially important. Expert knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) and the therapeutic area is a must. In-depth experience of project management and techniques and a sound grasp of team management principles would be very valuable.

In this position, you will collaborate with Vendor/CRO and other GDMs to achieve successful collaborative partnerships. This position recognizes opportunities and supplies solutions to strengthen the Vendor/CRO relationship.

Your Key Responsibilities

• Take a lead role implementing projects to advance Data Strategy initiatives. Work with business partners and internal and external partners to establish, align and confirm data management expectations.
• Is accountable for assembling content and integration requirements for CRF and other data collection tools; leads conventions and quality expectations for clinical data; leads expectations for dataset content and structure; sets timeline and regular follow-up to ensure delivery of all data management landmarks.
• 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 to facilitate appropriate quality, scientific content, organization, transparency, format and consistency. Ensures compliance with regulatory guidelines.
• Takes leadership of the assigned clinical working group(s) to ensure that DM and Therapeutic Area (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 objectives are optimally completed.
• Takes the lead in acquiring and sharing standard methodologies with internal partners. Leads others in implementing process, system, and tool improvement initiatives within DM.
• Coordinates the assessment of real-time inspection readiness of all DM results for the trial. Participates in regulatory agency and J&J internal audits as is vital.
• Presents information and trains investigator and site monitors.
  

May undertake the principal responsibilities of a Clinical Data Manager, as appropriate.

Qualifications

We would love to hear from YOU, if you have:

Must haves: to be considered for this role, please ensure the minimum requirements are evident on your resume

• BA/BS/MS degree or equivalent professional experience
• Data management experience
• Experience in clinical drug development within the pharmaceutical industry or related industry
• Vendor oversight experience
• Team leadership experience
• Project management experience
• Extensive experience in Global Clinical Data Management
  

Are you ready to make an impact?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

About Janssen, The Pharmaceutical Companies Of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working diligently to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Ready to be part of something great? Don’t forget to apply. We want YOU!

Primary Location

Belgium-Antwerp-Beerse-

Other Locations

Europe/Middle East/Africa-France, Europe/Middle East/Africa-Switzerland

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

R&D

Requisition ID

2206049204W