Clinical Data Manager

ESA - European Society of Anaesthesiology

Clinical Data Manager

ESA - European Society of Anaesthesiology

Brussels, Belgium 

The European Society of Anaesthesiology (ESA) is the European Regional Section of the World Federation of Societies of Anaesthesiologists (WFSA) and comprises of individual and national society members. The ESA promotes the exchange of information between European anaesthesiologists and focuses on the distribution of useful and qualitative information in regard to anaesthesiology amongst its members. By encouraging education, research and scientific progress, the ESA aims to raise the standards and to improve safety and quality of patient care. ESA works to facilitate and harmonise the activities of national and international societies of anaesthesiologists in Europe.

Furthermore, the ESA organises the European Anaesthesiology Congresses, Euroanaesthesia and the Focus Meeting on Perioperative Medicine, presenting a comprehensive scientific programme consisting of refresher course lectures, symposia and workshops, as well as the presentation and discussion of the latest research. Members and non-members from more than 80 countries from around the world attend these meetings.

To strengthen their research team, we are currently looking for a m/f: CLINICAL DATA MANAGER.

Job description

Your responsibility as a Clinical Data Manager consist of:

  • Participating in the review of Clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical analysis);
  • Developing Data Management Plan (DMP), maintaining DMP throughout lifecycle of study project and ensuring DMP is followed according to study design and requirements;
  • Developing Case Report Form (CRF), electronic and/or paper;
  • Developing database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, and query logic and data validations;
  • Leading EDC database (DB) specification process;
  • Developing Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs;
  • Reconciling electronic data transfers from vendor to Sponsor;
  • Developing test scripts and execution logs for User Acceptance Testing (UAT);
  • Coordinating of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report;
  • Maitaining/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts;
  • Performing training on study trial for EDC and create user guides;
  • Ensuring clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and original database lock- included but not limited to: data reconciliation;
  • Assisting in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit;
  • Coordinating the archiving of study databases and related documents;
  • Performing close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs;
  • Assisting in reconciling AE/SAE data in Safety DB and/or other Data;
  • Management DB, including but not limited to, performing MedDRA and/or WHO coding;
  • Assisting and providing input into study and project level data analysis plan;
  • Coordinating and communicating with DB vendors on consistent basis to address Clinical team requests, project plans, and/or eCRF development activities;
  • Collaborating with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems;
  • Participating in the preparation and presentation of data, when applicable;
  • Ensuring data system compliance by following the established guidelines of national and international regulatory authorities;
  • Participating in conference calls and/or meetings with vendors;
  • As a software manager you will monitor progress against intermediate and final development targets;
  • Reviewing progress and identify potential obstacles towards completion;
  • Monitoring quality to ensure that products meet technical and business objectives.

Profile

  • You obtained a bachelor’s or master’s degree in a science/IT related field and you have at least 5 years of relevant experience within a medical device or pharmaceutical Clinical Trial sector, either within industry or within a non-profit organisation or CRO;
  • You have at least two years data management and/or related work experience in Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology;
  • You have proven experience in software management in a clinical trial setting;
  • You have working knowledge of Clinical database applications such as EDC;
  • You have previous experience in working with other clinical databases such as Oracle Clinical, SAS, other;
  • You have knowledge of System Development Life Cycle;
  • You are an enthusiastic person, pro-active, reliable, and flexible;
  • You are a team player with the ability to work independently and autonomously;
  • You have excellent verbal and written skills, good organizational, interpersonal, and team skills;
  • You are good in Project coordination;
  • You show excellent communication skills in English both oral and written. Any other language is a plus.

Offer

  • A challenging and varied role in a high demanding but pleasant, multicultural and international environment;
  • An interesting salary package with fringe benefits;
  • ESA is located in the center of Brussels and easily accessible by public transport.

Interested?

Please send your application to Hudson, attn. Lore Vermeulen via email: lore.vermeulen@jobs.hudson.com. Please mention reference BE773303 or call (+32)(0)92 425 374 for more information.

Replies will be dealt with swiftly and in strictest confidence.

Don't forget to mention EuroPharmaJobs when applying.

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© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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