Sso Study Start-up Manager - Ciudad de México - Novartis

Novartis

Empresa verificada

Ciudad de México

hace 2 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

390215BR

SSO Study Start-Up Manager:

Mexico

About the role

Location:
Ciudad de Mexico

On this role, you will be responsible for

The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country.

Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team.

In satellite countries acts as primary back-up and deputy of the country manager.

Key responsibilities:
Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio

Collaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
Accountable for timely startup activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects
Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable
Ensures that study startup activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required
Prepares and finalizes local submission package for submission to IRB/IEC, CTA Hub (Europe: acc. to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs)
Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders
Coordinates reportable events and notifications to IRB/IEC and Health Authorities as applicable
Accountable for timelines, accuracy, and quality of country 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

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._

Role Requirements
Essential Requirements

Education:

A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable

Languages:

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

Experience/Professional requirement:

Minimum 5 years' experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
Capable of leading in a matrix environment, without direct reports

You'll receive:

Competitive salary, annual bonus, life insurance, home office policy (home office 2x a week), retirement and wellbeing plans, flexible working arrangements, birthday day-off, parental leave, subsidized dining facilities, health insurance, employee recognition platform, Gympass, employee resource groups and virtual self-development tools.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Division
Development

Business Unit

GCO GDD

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