Senior Operation Data Manager (gn)

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MorphoSys’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborating closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich!

Your Responsibilities:

  • Acts as a Cross Departmental Lead for evaluation of DM system requirements, selection and implementation
  • Organize meetings with vendors, review project plans and timelines
  • Evaluate the need for new DM SOPs and/or update of the existing DM SOPs related to changes in system and processes in DM
  • Participate in the definition and implementation of eCRF standards
  • Acts as Lead Data Manager on clinical trials
  • Provide clinical data management support to the clinical trial teams (CTT)
  • Oversee the development and implementation (including change management) of clinical data management activities outsourced to the vendor in a clinical trial (i.e. eCRF design, database set-up, Database Specification, Data Transfer Specifications, UAT Test Scripts and Execution Logs, integration of historical control data, Data Management Plan, etc.) to ensure quality and adherence to the timelines
  • Participate in meetings with vendors to review project plans and timelines, address and resolve data related issues identified in the trial and requests from the CTT
  • Coordinate the UAT of eCRF build and validation documents including but not limited to edit check document, issue logs, UAT summary report with the vendor
  • Keep an oversight of data cleaning, data mapping and SDTM data transfer for assigned projects
  • Ensure reconciling of SAE data in Safety Database and Clinical Database by the vendor
  • Support in defining and quality control of data listings, summary table validation, data specifications and/or process data transfers by the vendor in preparation for statistical review
  • Ensure implementation of all data processing quality steps as per applicable SOPs
  • Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock - included but not limited to data reconciliation and /or coding in agreement with all regulatory requirements
  • Coordinate the archiving of study databases and related documents
  • Manage project budget

Job Qualifications:

  • Bachelor's or Master’s Degree or equivalent in scientific or health care discipline
  • Or at least 6 years of data management work experience in pharmaceutical industry or service provider
  • Experience with selection and implementation of DM/PM tools
  • Experience with EDC system interfaces and other eTools such as ePRO, IVRS, etc.
  • Experience with EDC systems and (e)CRF design (experience with Rave [Medidata] is a plus)
  • Deep knowledge of Data Management processes and documentation
  • Experience with system testing, specifications and scripts writing and validation
  • Experience with coordination of Data Management activities with external vendors and across departments
  • Knowledge of standards CDISC / SDTM, E2B R2 / R3 is a plus
  • Knowledge of WHO Drug and/or MedDRA dictionaries, coding experience is a plus
  • Experience in oncology and inflammatory diseases
  • Good knowledge of industry standards, such as the ICH guidelines, CDISC standards / implementation guides, 21 CFR Part 11, and FDA guidelines
  • Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure and in a team environment to meet established deadlines
  • Experience in working in matrix organizations
  • Team player with well-developed interpersonal abilities
  • Excellent written and oral communication skills in English

We offer:

  • Creative working in X-functional teams
  • Opportunities to work in Phase 3 studies and potential submissions
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses

Thank you for your interest! We are looking forward to receiving your pertinent application documents. For your application please use exclusively our career portal. We offer not only excellent career prospects, but also support you from the very beginning – even helping you move if necessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg