Ssu Cra - Ciudad de México - Novartis

Novartis

Empresa verificada

Ciudad de México

hace 4 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

Site relationship management role to ensure sustainable trial start-up at Site.

The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs.

Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).

Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager

Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
Accountable for timely startup activities from country allocation until site greenlight at assigned sites
Conducts site selection visits, verifies site eligibility for a specific study
Main contact for trial sites during site selection, study startup and IRB/IEC and HA submission preparation
Ensures that milestones (KPIs) and time schedule for study startup are met as planned
Facilitates the preparation and collection of site and country level documents
Collects submission relevant sitespecific documents (e.g., FD, CV, GCP certificates, DSL...) for all relevant site personnel within agreed timelines
Supports SSU Manager in preparation of countryspecific documents, e.g., ICF, patient facing materials, etc.
Supports SSO Study Start-Up Manager and assigned sites in vendor setup activities
Prepare and finalize site specific documents for submission
Negotiates investigator payments as needed
Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed
Updates all systems until site Green Light on an ongoing basis
Supports preparation of audits and inspections as applicable
Supports reduction of formal sitespecific IRB/IEC deficiencies
Ensures timelines, accuracy, and quality of country and site TMF documents in study startup to ensure TMF inspection readiness
Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
Implements innovative and efficient processes which are in line with Novartis strategy
Ensures sites are prepared for "Green Light" and is accountable to send the Green Light to SSU Manager for review and approval

Externally facing role with impact on Principal Investigators and Institution/Site business offices.

External engagements with vendor partners to lead site issue resolution as needed.
Partners with execution Clinical Research Associate to ensure seamless transition of site responsibility at time of site initiation.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements

Education:

A degree in scientific or health discipline, preferably with clinical operations experience (or, for

United States: 4-year degree plus relevant, related healthcare experience)

Languages:

Fluent in both written and spoken English, local language as needed

Experience/Professional requirement:

Minimum 3 years' experience in clinical operations in a monitoring / site management role
Advanced understanding of all aspects of clinical drug development with particular emphasis on trial setup, execution, and monitoring
Central/inhouse monitoring or field monitoring experience is desirable

Competencies:

Strong site management capabilities with demonstrated negotiating and problemsolving skills
Advanced understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards

Skills & Knowledge:

Strong interpersonal, negotiation and conflict resolution skills
Ability to travel, e.g., for site selections, if applicable
Ability to manage multiple priorities and manage time efficiently
Fast change adaptability to best partner & influencing with sites on fast changing landscape
Trust and rapport building is a very important skill needed
Good communication skills, ability to influence others & Relationship management

Division
Global Drug Development

Business Unit

GCO GDD

Country
Mexico

Work Location
Ciudad de México

Company/Legal Entity

NOV CORPORATIVO MEX

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Early Talent
No