Ai Recruiting Engineer - Build Tools, Lead Teams (Remote)

Jetbridge Ai; Partido de Quilmes; A distancia; ARS 182.310.000 - 273.465.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Senior Clinical Data Team Lead to drive end-to-end data management for global trials. You will lead DM deliverables, coordinate cross-functional teams, and ensure compliance with GCP and regulatory guidelines while maintaining strong client relationships.

As a senior lead, you will manage budgets, timelines, and resource planning, mentor junior staff, and push continuous improvements to processes and data quality across programs.

Formación

• Bachelor's degree in health, clinical, or related sciences.
• 7 years DM experience; 5+ years as a CDM lead.
• Experience delivering multiple global trials through full DM lifecycle.
• Strong negotiation and bid defense experience with customers.

Responsabilidades

• Lead data management deliverables for multi-study programs.
• Manage client relationships and negotiate timelines and budgets.
• Mentor junior DTL staff and coordinate DM team.
• Ensure compliance with GCP and regulatory guidelines.
• Sign off on data management plans and drive process improvements.

Conocimientos

Data Management

CDM Leadership

Project Management

Client Negotiation

GCP & Regulations

Stakeholder Management

Technical DM Expertise

Educación

Bachelor's Degree in Health/Clinical Sciences

Herramientas

EDC Systems

SAS

Data Viz Tools

Descripción del empleo

Mexico City, Mexico
Buenos Aires, Argentina
São Paulo, Brazil
Bogota, Colombia
Full time
R

Job Overview

Independently manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and/or a leadership role in a specific CDM task (e.g., Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Essential Functions

Client Management:

• Serve as primary point of contact for customer on data management deliverables.
• Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies/programs of global studies Provide leadership and senior support to DTLs on multiple large global studies/programs.
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources.
• Maintain strong customer relationships.
• Ensure open communications with customer and IQVIA management to independently manage and meet contractual obligations.

Service Management:

• Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables.
• Provide training and development on data management expertise to junior team members.
• Establish strong communications with Data Operations team, functional leads, project managers and all other stakeholders.
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects.
• Serve as the escalation point for unresolved data issues.
• Independently work with client data managers, vendors, internal team members for resolution.
• Ensure appropriate resources are assigned to meet project deliverables.
• Create and/or review and sign-off on all data management plan (DMP) documents.
• Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW.
• Implement proactive quality management plans across multiple projects/programs/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions.
• Continuously look for opportunities to improve service.
• Develop and work with team to implement plan to re-organize and drive change (possibly across a customer account).
• Ensure timely follow-up and resolution of compliance issues.
• Serve as Subject Matter Expert (SME).
• Provide leadership and expertise in a specific CDM task or technology.
• Serve as customer site lead for one or more customers.
• Train and mentor junior DTL staff in DM expertise.
• May coordinate the work of more junior DTL staff.
• Independently maintain internal tracking databases and systems.

Financial Management/Business Development Support:

• Independently manage SOW/budget.
• Review financial reports monthly and participate in project reviews as requested.
• Identify out of scope tasks and track change orders to completion.
• Participate in pricing discussions across customer account.
• Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
• Independently support RFP process (review RFP documents, pricing, attend bid defense).

Other:

• Independently bring process improvements and solutions to the CDM team/CDM department.
• Lead a focus team or global or local best practice team.
• Communicate lessons learned and/or present in CDM workshop(s).
• Manage the development and implementation of new technology or tool.
• Present at professional conferences and/or publish articles in professional journals.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions.
• Perform other duties as directed by the functional manager.

Qualifications

• Bachelor's Degree Health, clinical, biological, or mathematical sciences, or related field Req
• 7 years direct Data Management experience, including 5 or more years as a CDM project lead. Equivalent combination of education, training, and experience.
• Previous experience and proven competence in managing delivery of multiple global trials through full DM life cycle (i.e., large trials of at least 1000 patients).
• Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology).
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology.
• Knowledge of operating procedures and work instructions and the ability to apply them in practice.
• Knowledge of Good Clinical Practices and relevant regulatory guidelines.
• Comprehensive understanding of clinical drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology.

Work Schedule

Standard (Mon-Fri)

Job Description

Join Us as a Senior Clinical Data Team Lead - Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Senior Clinical Data Team Lead, you will act as a lead data manager for one or more projects and serve as a liaison to the Project Lead and/or client as required.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

EEO Statement

EEO Minorities/Females/Protected Veterans/Disabled