Clinical Data Management Systems Lead

hace 1 mes


San José, San José, Costa Rica Msd A tiempo completo

Msd seeks an experienced Clinical Data Management Systems Lead to join our team.

About the Role

As a Clinical Data Management Systems Lead, you will be responsible for creating and developing clinical databases and data transfer files according to written specifications. You will lead and participate in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in the transfer of electronic data files into the Clinical Data Management System (CDMS).

You will interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables. Your responsibilities will include data mapping deliverables, such as SDTM structure set-up and transformation maps to support multiple clinical programs.

Key Responsibilities
  • Create and develop mapping specifications to meet SDTM structure requirements utilizing E2E visibility tools to ensure quality and timeliness of data flow.
  • Lead and participate in developing transformation logic, and scripts to aid in the flow of data downstream for Analysis and Reporting.
  • Responsible for reporting deliverables supporting data cleaning and verification and any external data captured in clinical studies.
  • Coordinate data reporting activities for multiple clinical programs.
  • Create and review reporting specifications to ensure high-quality deliverables, meet SDTM structure requirements, and the needs of the business.

You will lead and participate in the review of standard and template reports, and scripts to aid in the review of data to ensure a quality database. Additionally, you will assume responsibility for all database Archiving and Decommissioning activities in support of multiple clinical programs.

Requirements
  • B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.
  • Knowledge of database structures and available tools to manage, extract, report, and warehouse data.
  • Minimum 4 years of database development or data programming experience, at least three of which including clinical databases.
  • Demonstrated strong technical proficiency in a Clinical Data Management Systems (i.e., InForm, Inform Architect, Central Designer, SQL-PL/SQL).
  • Minimum 4 years of experience with CDISC Standards, (SDTM, CDASH, Define.xml).
  • XML, Java.
  • ELT tools.
  • 3+ years' experience in data transformations and data loading in tools such as InForm.
  • 2+ years' experience in System Development Lifecycle Management / system validation knowledge.
  • 3+ years' experience with reporting tools such as Cognos or JReview.
  • Experience in eCRF generation for site documentation and downstream regulatory compliance deliverables.
  • Advanced knowledge of the Data Management process from study start-up through close-out.
  • Ability to collaborate and communicate with cross-functional stakeholders to interpret and ensure quality report specifications and input to report development.
  • Effective communication skills (oral and written) with the ability to communicate with both the technical and business areas.
  • Strong organizational and critical thinking skills.
  • Keen sense of urgency and customer focus.
  • Ability to work cross-functionally and as part of a team.
  • Able to work independently, under pressure, and change environment with flexibility.
Estimated Salary Range

$120,000 - $180,000 per year, depending on experience.



  • San José, San José, Costa Rica Msd A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Clinical Data Management Systems Lead to join our team at MSD. In this role, you will be responsible for leading the development and implementation of clinical data management systems, ensuring that they meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesLeverage your...


  • San José, San José, Costa Rica Msd A tiempo completo

    Msd is seeking a Clinical Data Management Lead to join our team.Job DescriptionThe Clinical Data Management Lead will be responsible for leading and participating in the review of electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts to aid in transfer of electronic data files into the Clinical...


  • San José, San José, Costa Rica Microport Orthopedics Sa A tiempo completo

    At MicroPort Orthopedics Sa, we're seeking a skilled Clinical Data Management Associate to join our team. As a key member of our data management group, you'll play a vital role in ensuring the success of our clinical trials.Job Description:As a Clinical Data Management Associate, your primary responsibility will be to manage study start-up tasks, including...


  • San José, San José, Costa Rica Microport Orthopedics Sa A tiempo completo

    We are seeking an experienced Clinical Data Management Associate to join our dynamic team at MicroPort Orthopedics Sa. This role will be responsible for overseeing the management of clinical trial data, ensuring accuracy, integrity, and compliance with regulatory requirements.About the RoleThe successful candidate will possess strong analytical skills,...


  • San José, San José, Costa Rica Msd A tiempo completo

    About the Role">Msd is seeking a highly skilled Clinical Data Management Specialist to join our team. This role will be responsible for creating and developing clinical databases and data transfer files, leading and participating in the review of electronic case report forms (eCRF) and edit checks, and reporting deliverables supporting data cleaning and...


  • San José, San José, Costa Rica Msd A tiempo completo

    Job OverviewMsd is seeking a highly skilled Clinical Data Management Analyst to join our team. This role will be responsible for executing end-to-end data management activities for clinical trials, developing and maintaining data management tools and systems, ensuring data integrity through review and reconciliation, and managing queries, medical coding, and...


  • San José, San José, Costa Rica Msd A tiempo completo

    At Msd, we offer a competitive salary of $85,000 to $110,000 per year, depending on location and experience.Job OverviewWe are seeking an experienced Clinical Data Management Specialist to join our team. In this role, you will be responsible for creating and developing clinical databases and data transfer files according to written specifications.About the...


  • San José, San José, Costa Rica Msd A tiempo completo

    Job OverviewWe are seeking an experienced Clinical Data Management Analyst to join our team. As a key member of our clinical operations team, you will be responsible for executing end-to-end data management activities for clinical trials.Key Responsibilities:Develop and maintain data management tools and systems to support clinical trial data management...


  • San José, San José, Costa Rica Msd A tiempo completo

    Msd is seeking a highly skilled Clinical Data Management Analyst to join our team. As a key member of our data management department, you will be responsible for executing end-to-end data management activities related to clinical trials.About the Role:The successful candidate will have a bachelor's degree in any field, preferably in health sciences. They...


  • San José, San José, Costa Rica Msd A tiempo completo

    About UsOur company, MSD, is a research-driven biopharmaceutical leader that applies its global capabilities to aggressively advance and discover innovative medicines and vaccines. We are dedicated to making a significant impact on the world of healthcare through our commitment to science and by serving the needs of physicians, patients, payers, and other...


  • San José, San José, Costa Rica Msd A tiempo completo

    We are seeking a Senior Clinical Data Manager to join our team at MSD. In this role, you will be responsible for creating and developing clinical databases and data transfer files according to written specifications.As a Senior Clinical Data Manager, you will lead and participate in the review of electronic case report forms (eCRF) and edit checks, database...


  • San José, San José, Costa Rica Msd A tiempo completo

    **About the Role**We are seeking a highly skilled Clinical Data Operations Manager to join our team at MSD. This is an exciting opportunity for a motivated and experienced professional to lead our clinical data operations functions in Costa Rica.The successful candidate will be responsible for ensuring the operational effectiveness and efficiency of our...

  • Data Engineering Lead

    hace 2 semanas


    San José, San José, Costa Rica Msd A tiempo completo

    About the RoleWe are seeking a highly skilled Data Engineer to lead our team in developing and maintaining clinical databases. This is a critical role that requires strong technical expertise, leadership skills, and attention to detail.Job SummaryThe successful candidate will be responsible for designing, implementing, and managing large-scale data systems,...


  • San José, San José, Costa Rica Msd A tiempo completo

    Msd is seeking a skilled Clinical Data Management Analyst to execute end-to-end data management activities for clinical trials. As a key member of our team, you will be responsible for developing, validating, and maintaining data management tools and systems, ensuring compliance with company Standard Operating Procedures and guidelines.**Job...

  • Lead Data Analyst

    hace 2 meses


    San José, San José, Costa Rica Msd A tiempo completo

    Job SummaryMsd is seeking a highly skilled Lead Data Analyst to join our team. The successful candidate will be responsible for creating and developing clinical databases and data transfer files according to written specifications.Key Responsibilities:Create and develop clinical databases and data transfer files according to written specificationsLead and...


  • San José, San José, Costa Rica Fortrea A tiempo completo

    Company Overview: Fortrea is a leading global contract research organization (CRO) that combines scientific rigor with decades of clinical development experience. With operations in over 90 countries and more than 19,000 staff members, Fortrea provides a wide range of solutions for pharmaceutical, biotechnology, and medical device customers across multiple...

  • Clinical Data Specialist

    hace 4 semanas


    San José, San José, Costa Rica Saj Fortrea Costa Rica Srl A tiempo completo

    Company Overview: As a leading global contract research organization, Fortrea is dedicated to delivering high-quality clinical development solutions across various therapeutic areas.">About the Role: We are seeking a motivated Clinical Data Specialist to join our team in Costa Rica. This individual will be responsible for conducting clinical data reviews,...

  • Clinical Data Specialist

    hace 2 semanas


    San José, San José, Costa Rica Fortrea A tiempo completo

    Job OverviewServe as a key member of the project team with primary responsibility for clinical data review, query generation and resolution to support the delivery of clinical data according to client quality and integrity specifications.Main ResponsibilitiesReview clinical trial data in accordance with global data management plans and standardized processes...


  • San José, San José, Costa Rica Msd A tiempo completo

    At MSD, we are seeking a highly skilled Clinical Data Integration Specialist to join our team in Costa Rica. This role will be responsible for the operational effectiveness and efficiency of GCDI functions within the geography as well as strategic aspects.The ideal candidate will be a self-directed and self-driven individual who can operate in a Volatile,...


  • San José, San José, Costa Rica Labcorp A tiempo completo

    **Company Overview:** Labcorp is a leading healthcare company dedicated to improving human health. Our organization operates with integrity, respect for people and the environment.As a Clinical Data Analyst at Labcorp, you will play a vital role in ensuring data quality and accuracy. This position involves collaborating with project teams to set up,...