Junior Data Manager

Insud Pharma; Madrid; Presencial; EUR 35.000 - 45.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company based in Madrid is seeking a Junior Data Manager to support data management activities in clinical trials. The ideal candidate will have 2-3 years of experience in data management and a degree in a relevant field. Strong communication and leadership skills are essential. This position is onsite, offering an opportunity to work within a dynamic team. Flexible and innovative thinkers will thrive in this role.

Formación

• 2-3 years of experience in data management, specifically in clinical trials.
• Fluent in English; knowledge of additional languages is a plus.
• Extensive knowledge of data management processes.

Responsabilidades

• Assist all data management aspects of a clinical study with minimal oversight.
• Support data cleaning activities and manage data deliverables.
• Collaborate with the study team to ensure quality and compliance of data management processes.

Conocimientos

Data management

Communication

Leadership

Teamwork

Adaptability

Educación

Degree in Engineering, Health Data or similar

Herramientas

Data management tools

Descripción del empleo

Overview

Position: Junior Data Manager | Location: Madrid (onsite). Experience: 2-3 years of experience in data management. Extensive experience in clinical trial project data management and coordination.

Global Responsibility

The Junior Data Manager will support the execution and monitoring of operational activities related to data management in clinical trials, working under direct supervision. They will collaborate with the study team to ensure quality and compliance of data management processes, contributing to the successful conduct of clinical projects.

Specific Responsibilities

• Assist all data management aspects of a clinical study with minimal oversight, including study start-up activities, and guide the study team through change orders and protocol amendments
• Assist in the development of DM documents including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilize templates and standard guidelines to initiate documents, but exercise critical thinking and discretion to tailor documents to study needs
• Support data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation and non-CRF data reconciliation. Gather cross-functional input to create custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths
• Demonstrate collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker / Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.)
• Assist in managing data deliverables processes, including database locks
• Ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct
• Support the coordination of work performed by vendors / CROs as appropriate to ensure quality of the product

Competencies / Career level

Innovation, customer orientation, communication, teamwork, adaptability / flexibility, productivity, self-development, sense of urgency, initiative. Technologically savvy; quickly picks up new information

Accountabilities

KPI related to the job.

Requirements and personal skills

• Education: Degree in Engineering, Health data or similar.
• Languages: Fluent English, knowledge of other languages will be an asset.
• Experience (years / area): 2-3 years of experience in data management. Extensive experience in clinical trial project data management and coordination.
• Specific Knowledge: Extensive knowledge of data management and tools.
• Travels: Willingness to travel occasionally.
• Personal skills: Strong communication and leadership skills. Strong negotiation skills as well as excellent influencing and training / mentoring skills. Ability to focus on multiple deliverables and protocols simultaneously.