Global Clinical Risk Manager - Trials & QA

Johnson & Johnson Innovation

Madrid

Presencial

EUR 62.000 - 106.000

Jornada completa

14 días+

Generador de candidaturas

Una candidatura completa en un minuto — currículum adaptado y carta de presentación, listos para enviar.

Supera los filtros ATS

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Vacation days

Parental leave

Well-being programs

Descripción de la vacante

Johnson & Johnson is currently seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Spring House, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium; and Basel, Switzerland. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Formación

A minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required.
A minimum of 8 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required.
Proven strong GCP Quality and/or clinical trials experience is required.
Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross-functional team environment is required.
Flexibility to respond to changing business needs is required.
Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
Proficiency in Microsoft Office Applications is required.
Experience with fundamentals of clinical trial risk management is preferred.
Experience working to ICH guidelines is preferred.
Knowledge of GMP/GLP/GPvP is preferred.
Health Authority Inspection experience is preferred.
Strong Project Planning/Management skills is preferred.
Experience in managing escalations and CAPA support/advisement is preferred.
Experience with data analytics and/or data visualization tools is preferred.
Experience with Data Science and Digital Health is preferred.
Requires proficiency in speaking and writing English.
Up to 10% travel, primarily domestic with some international travel.

Responsabilidades

Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.
Leads regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned).
Maintains CQP (Clinical Quality Plans) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations
Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews
Communicates and facilitates risk updates to R&D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).
Highlight new potential systemic risk to RDQ CRM management.
Develops and ensures a consistent interpretation of issues that require quality investigations
Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.
In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit)
Drives ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
Provides support for Investigator, Sponsor-Monitor and third-party inspections including post inspection support
Provides independent advice on questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.