J&J Family of Companies Senior Global Data Manager in Leiden, Netherlands
‘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.
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
Janssen Pharmaceuticals (Research & Development), a Johnson & Johnson company is recruiting for a Senior Associate Scientist within the Global Clinical Development Operations (GCDO). Janssen R&D develops treatments that improve the health and lifestyles of people worldwide in five different therapeutic areas: Neuroscience, Cardiovascular and Metabolic Diseases, Immunology, Infectious Diseases and Oncology.
Illustrative Responsibilities :
Takes a leadership role with the Data Management CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations 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.
Establishes conventions and quality expectations for clinical data.
Establishes expectations for dataset content and structure.
Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.
Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal Data Delivery Lead direction.
Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
Ensures real-time inspection readiness of all deliverables for the trial; Participate in Regulatory Agency and J&J internal audits as necessary.
Plans and tracks 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 departmental and therapeutic area trial needs and deliverables are met.
Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
Identifies and participates in process, system, and tool improvement initiatives within department
Presents and trains at investigator and monitor meetings
BA/BS degree (required)
3-5 years Data management experience minimum
Experience in clinical drug development within the pharmaceutical industry or related industry is required.
Vendor oversight experience (desired).
Team leadership experience (desired).
Project management experience (desired).
Technically minded (RAVE, SDTM CDISC, SAS programming knowledge a plus)
Excellent communication skills
Vaccine knowledge is a plus
Thorough command of English (oral and written)
Ability to work in complex environment
Solution oriented, good problem solving skills
Janssen-Cilag Netherlands (8345)
Beheer klinische gegevens