Clinical Data Manager (0.8 - 1.0 FTE)

  • Antareslaan 41, 2132 JE Hoofddorp, Netherlands
  • Full-time

Company Description

Ergomed and PSR joined forces together to create a leading orphan drug development expert team that will allow our clients to implement patient-driven solutions in their clinical trials. People living with a rare disease are at the center of everything we do at PSR. As part of the Ergomed Group, our joint mission is to become the leading global specialized CRO in Orphan Drugs. Through different ways, we try to help these patients and make sure their voices are heard. Are you ready for a new career in the rare disease niche?

Job Description

We are looking for a (senior) clinical data manager with programming skills (SQL/SAS) to be based in Hoofddorp. You will work closely with your direct colleague in Hoofddorp and with other DM colleagues in Köln, Germany. PSR Orphan Experts is looking for a Data Manager whose personality and work-life balance fits with working in a transitional and therefore dynamic and changing environment. Accountability / Ownership:

  • Provide oversight and coordination of all DM activities in a project.
  • Coordinate the Data Entry Clerks (DEC) and Database Developers (DBD) allocated to a project.
  • Development of Case Report Forms (CRFs) for data collection.
  • Creation, update and filing of project-related documentation (e.g. Data Management plan (DMP), Data Validation Plan (DVP), Data Entry Guideline, Database Specification Document (DBSD), Database Report (DBR) in the DM TMF.
  • Performing and documenting periodic QC of DM TMF files and follow up on all action items until closure
  • Perform clinical database development, including data entry screen design, testing and validation based on the DBSD.
  • Program, test and validate edit checks.
  • Combine external data with the clinical database in cooperation with the Statistical Programmer.
  • Export data from the clinical database to authorized recipients (e.g. in CDISC SDTM format).
  • Generation of queries based on edit checks or errors and omissions identified during data entry and manual data review to resolve identified problems.
  • Perform database lock and unlock procedures.
  • Provide validated data exports from the EDC system or the clinical database to authorized recipients (e.g. related to SAE Reconciliation and medical coding where applicable).
  • Communication with the sponsor in close cooperation with the PM.
  • Attend meetings with the project team and/or client

Qualifications

  • Proven experience working within clinical data management and good technical skills (SQL and SAS)
  • Ability to project manage client relationships and ongoing data management projects
  • Experience of EDC systems and design of eCRF’s
  • Able to work in a fast paced environment and manage multiple projects
  • A minimum of a science based Bachelors degree

Additional Information

Next to the desired professional profiles, we also take into account personality attributes, like a person’s communication style, in order to create the best possible match. Can you stay true to yourself and work in a way that suits you best? You can if you have a good idea of who you are – and if we do too. PSR strongly believes that every individual is so much more than his or her resume. Everyone should have the freedom to develop and grow as a person. To achieve this, we take our responsibility and ensure that everyone can make the very most of their unique talents.

At PSR, we strongly value healthy business operations and a friendly work environment. Our work is guided by a sincere interest in rare diseases. It also inspires us to regularly show our team members how much we appreciate them. 

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