Boston, United States
about 1 month ago
Participate in the review of the clinical trial documents (e.g. protocols, case report forms and statistical analysis)
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. 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 and /or coding in agreement with all regulatory requirements
Coordinate the archiving of study databases and related documents
Author of the Data Management related SOPs and responsible for the period update of these SOPs
Job Qualifications, Experience & Skills
BS required, MS Degree strongly preferred, in the field of data management or related subject
7+ 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 layout
Experience in handling study migrations
Ideally successfully completed CCDM certification
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 processes
Ability to prepare data for biostatistical analysis
Knowledge of CDISC / CDASH / SDTM standards
Knowledge of WHO Drug and MedDRA dictionary, coding experience is a plus
Excellent organizational and time management skills
Experience in working in matrix organizations
Team player with well-developed interpersonal abilities
Good written and oral communication skills in English
MorphoSys is dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from serious diseases, with a focus on cancer. Living up to the origin of our name – Metamorphosis – we have embarked on an ambitious transformation from a leading R&D company to a fully integrated biopharmaceutical company with an approval for a breakthrough cancer therapy.
Over the last two decades, MorphoSys forged partnerships with many of the leading global pharmaceutical companies. Together with our global partners, we have developed more than 100 product candidates, of which 27 are currently in clinical development – one of the broadest pipelines in the industry.
Headquartered in Planegg, near Munich, Germany, MorphoSys, including the fully owned U.S. subsidiary MorphoSys US Inc. in Boston, MA, has 600+ employees.