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Clinical Data Manager

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Clinical Data Manager

  • Location:

    Boston, United States

  • Sector:

    Life Sciences

  • Contact:

    Sam O'Donoghue

  • Job ref:

    563

  • Published:

    about 1 month ago

  • Expiry date:

    2021-01-31

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)

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.