Clinical Data Manager (gn)

 StepStone ·  09.01.2019 ·  Planegg Raum München ·  MorphoSys AG

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, collaborate 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!

We would like to fill the follow­ing vacancy as soon as possible:

Clinical Data Manager (gn)


Your Responsibilities:

Provide clinical data management support to the clinical trial teams (CTT)

Participate in the review of the clinical trial documents (e. g. protocols, case report forms and statistical analysis)

Participate in the selection process of appropriate vendors for outsourcing data management related activities

Oversee the development and implementation (including change management) of clinical data management activities outsourced to the vendor in a clinical trial (i. e. Data Management Plan, eCRF, Database Specification, Data Transfer Plan, UAT Test Scripts and Execution Logs, integration of historical control data 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; ensure CRF preparation as per CDISC standards

Participate in the definition and implementation of eCRF standards

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 andor coding in agreement with all regulatory requirements

Coordinate the archiving of study databases and related documents

Create and update the Data Management related SOPs

Your Requirements:

Successfully completed professional training (Master’s Degree or equivalent) in the field of data management

Ideally at least five years of data management and/or related work experience in pharmaceutical industry

Experience with EDC systems like ORACLE, InForm or Medidata Rave

Experience in (e)CRF design and programming

Experiences with other data management relevant systems, such as IVR systems and CDMS

SAS or “R” experience

Experience in defining standards for data import / export into/from clinical databases

Ability to coordinate data management activities with external vendors

Good understanding of global clinical trial practices, procedures and methodologies (such as ICH-GCP and 21 CFR part 11)

Experience with database decommissioning and archiving process

Ability to prepare data for biostatistical analyses

Knowledge of CDISC / CDASH / SDTM standards

Knowledge of WHO Drug and MedDRA dictionary

Excellent organizational and time management skills

Team player with well-developed interpersonal abilities

Good written and oral communication skills in English

We offer:

Creative working in X-functional teams

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 do not on­ly of­fer ex­cel­lent ca­reer prospects, but sup­port you from the very start – al­so help­ing you move.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg — ein Projekt von DIPLANET Digital Solutions Impressum