Clinical Project Manager - Ciudad de México - Novartis

Novartis

Empresa verificada

Ciudad de México

hace 1 semana

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

392018BR

Clinical Project Manager:

Mexico

About the role

Work Model:
Hybrid

Locality:
Ciudad de Mexico

About the Role:

The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in assigned geographies in compliance with Novartis processes and regulatory requirements.

The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies and countries.

The CPM is responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies in all assigned countries.

The CPM collaborates with the SSO Country Manager, SSO Country Head, SSO Feasibility Manager, SSO Study Start-up Manager and SSO Site Partnership Manager and other local stakeholders in the planning, execution, and delivery of their assigned studies in assigned geographies.

The CPM represents the voice of the cross-border community in assigned countries in the CTT.

The CPM is accountable for execution and reporting of assigned GDD studies in E2E product line Clinical Operations Program Head/Study Lead/ CPM - CRA.

Can be assigned partially to participate in the review process of Site Monitoring Plans across Portfolio.

Key responsibilities:

Supports SSO Study Startup Manager in the development of country/cluster/hub study execution plans and timeline commitments
Participates in the recruitment subteam and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
Proactively identifies risk and opportunities for the assigned studies within the country/cluster/hub and develops respective mitigation plans

Initiation and conduct of trials

When requested by the SSO Feasibility Manager supports the study feasibility by providing input to the study protocol, and operational aspects of the study
Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites and Country/Cluster/Hub personnel
Drives the conduct of the study, (tracks status, maintains relevant reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for getting approval from the STUDY LEADER on enrolling above site targets. Responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan.

Oversees local study team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and relevant regulations

Leads/chairs country/cluster/hub study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies
Maintains oversight of country/cluster/hub level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
Coordinates the study handover process with CRAs and their managers to ensure proper documentation and communication, when necessary
Tracks that all study closeout activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders

Delivery of quality data and compliance to quality standards

Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
Conducts or coordinates local investigator meetings as needed and ensures relevant documentation of training is archived in the Trial Master File
Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, develops risk management plans and communicates/ escalates to global teams and SSO Hub Head Portfolio, as appropriate
Accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports to ensure quality trial oversight and appropriate issue escalation
Escalation point for issues in monitoring visit reports (MVRs) for the assigned studies. Responsible for evaluating trends identified in MVRs and communicating/escalating to global teams, as appropriate. Communicates with CRAs and their managers to ensure issue resolution in a timely manner
Provides feedback about the quality of moni