Remote Centralized Monitoring Lead – Senior Dba/Dev

Zeo Consulting; Partido de Quilmes; A distancia; ARS 182.485.000 - 273.727.000; Jornada completa

Descripción de la vacante

Zeo Consulting is seeking an experienced data management leader to independently manage end-to-end delivery of CDM services for single or multi-service projects. You will ensure quality deliverables on time and within budget, and provide leadership to the CDM team on planning, execution, and close-out.

You will serve as SME for data management, guide client interactions, negotiate timelines and resources, and drive process improvements while maintaining compliant with GCP and regulatory

Formación

• 7 years direct Data Management experience, including 5+ years as a CDM project lead.
• Experience delivering global trials through full DM life cycle (i.e., large trials).
• Expert data management skills and DM process knowledge.
• Experience handling complex customer negotiations and bid defenses.
• Knowledge of Good Clinical Practices and regulatory guidelines.

Responsabilidades

• Serve as primary contact for customer on data management deliverables.
• Lead multiple large studies or programs and provide DM leadership.
• Manage project communications, issues, and process improvements.
• Negotiate timelines, financials, and resources with customers.
• Ensure milestones meet timelines and quality; mentor junior staff.
• Maintain strong customer relationships and escalation procedures.

Conocimientos

Data management

CDM project leadership

Client negotiations

Bid defense

Budgeting & financial mgmt

Vendor coordination

Mentoring

Educación

Bachelor's degree in health/clinical/biological/mathematical sciences

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

• 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 of global studies.
• 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.
• 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 stake holders.
• 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.
• 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).
• 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.
• 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.
• 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)

Environmental Conditions

Office

EEO Statement

EEO Minorities/Females/Protected Veterans/Disabled