Senior Laravel & React Developer (Remote)

Bluelightconsulting; La Pampa; Remote; ARS 136.687.000 - 227.811.000; Vollzeit

Zusammenfassung

Bluelightconsulting is seeking a Centralized Monitoring Lead to partner with project and clinical leads to deliver study objectives, ensuring quality, timeliness and cost efficiency across global projects. This remote LATAM role requires strong English communication and leadership of the monitoring team.

The position will oversee clinical deliverables, mentor junior staff, and ensure compliance with applicable regulatory requirements while coordinating resources across multiple sites and time

Qualifikationen

• Bachelor's degree in life sciences or related field.
• +3 years of clinical monitoring experience (remote or on site CRA) with ICH GCP knowledge.
• +2 years in a Lead role.
• Strong written and verbal communication skills including advanced command of English (Mandatory).
• Excellent organizational, problem solving and decision making skills.
• Ability to lead team and manage multiple global projects.

Aufgaben

• Lead the Centralized Monitoring team and oversee clinical deliverables on global projects.
• Act as Unblinded Clinical Lead and manage IP for assigned studies and regulatory needs.
• May act as Clinical Lead when not assigned and during project closeout.
• Manage project resources (CRAs/ Central Monitors/ Clinical Trial Assistants/ Centralized Monitoring Assistants).
• Monitor study metrics, trend analysis, and action planning; ensure RBM tools and templates are used.
• Develop analytics strategy and contribute to monitoring strategy and study plans.
• Attend study team/client meetings and provide input to decision makers.
• Mentor or coach junior staff.

Kenntnisse

Leadership

English proficiency

Communication

Problem solving

Ausbildung

Bachelor's degree in life sciences or related field

Jobbeschreibung

Centralized Monitoring Lead in LATAM (Remote)

Buenos Aires, Argentina

Mexico City, Mexico

Santiago, Chile

Lima, Peru

São Paulo, Brazil

Bogota, Colombia

Full time

R

Job Overview

The Leader of the Centralized Monitoring team, partner with the project and clinical lead to achieve the delivery of the project's overall objectives to the sponsor's satisfaction per contract, while optimizing speed, quality and cost of delivery and in accordance with IQVIA SOPs, policies and practices.

Essential Functions:

• Leadership activities:
• Leader of the Centralized Monitoring team, partner with the project and clinical lead to perform oversight on clinical deliverables on global assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.
• Unblinded Clinical Lead, including IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.)
• May act as Clinical Lead when there is not assigned to the study and at project close out.
• Manage project resources (CRAs/ Central Monitors/ Clinical Trial Assistants/ Centralized Monitoring Assistants)
• Analytical activities:
• Manage, monitor and complete study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan compliance etc.).
• Contribute to developing the study specific analytics strategy and work on developing advanced analytics.
• Support project management team to develop monitoring strategy, including monitoring triggers/thresholds.
• Attend study team and /or client meetings.
• Provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.
• Development and use of study management plans, and/or RBM specific tools and templates, and/or other study specific plans to evaluate the quality and integrity of the study.
• Ensure complete and accurate documentation of all the study specific tools and templates and keep the project Audit ready, including eTMF oversight.
• Mentors or coaches for junior staff.

Qualifications:

• Bachelor's degree in life sciences or related field.
• +3 years of relevant clinical monitoring experience (as remote or on site CRA). Advanced knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
• +2 years in a Lead role.
• Strong written and verbal communication skills including advanced command of English (Mandatory).
• Strong organizational, problem solving and decision making skills.
• Results and detail-oriented approach to work delivery and output.
• Excellent motivational, influencing, negotiating and coaching skills.
• Ability to work on multiple global projects and manage competing priorities.
• To lead team and effectively work in team.

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