(Senior) Clinical Data Manager

(Senior) Clinical Data Manager

Bavarian Nordic

Munich, Germany

To strengthen our Biometrics Department in Martinsried/Munich we are searching for a qualified (Snr.) Clinical Data Manager (f/m/d).

The (Snr.) Clinical Data Manager (f/m/d) is responsible for performing assigned data management activities and providing support for all clinical studies including vendor oversight, database setup, discrepancy management, external data reconciliation, data reviews, interim analyses and database lock. Responsible for contributing to protocols and preparing the DMP, CRF design, CRF completion guidelines, edit checks, database testing and updates throughout the trial lifecycle. Track and report progress for data management activities on assigned studies with proactive risk identification to ensure timely locking of databases. Provide ongoing identification and resolution of errors and inconsistencies in the clinical trial data to ensure high quality data. Provide oversight of data management activities as they relate to the study budget, assuring activities occur on time and within budget. Create, review and maintain global working practices, standards and templates.

Your Profile

  • BS/BA degree in relevant field of study;
  • 8+ years of clinical data management experience in pharmaceutical/biotech industry, or equivalent combination of education and experience working in an FDA regulated environment;
  • Experience with Medidata Rave is highly preferred.

Your Duties and Responsibilities

  • Provide clear verbal or written communication and hands-on support to project team members and to CROs related to CRF design, data quality and reporting of study results;
  • Actively participate in the development and review of documents such as departmental SOPs, guidelines, data management plans, dataset transfer standards, WHODrug and MedDRA coding standards, CDISC standards, QC/QA, and data validation plans;
  • Collaborate with Clinical, Biostatistics, Statistical Programming, Drug Safety, Quality, CROs, technology providers, and other groups;
  • Ensure data integrity across projects following ICH, Good Clinical Practices (GCP) and Standard Operating Procedures (SOP);
  • Act as lead data manager with responsibility for multiple studies, and ensuring consistency across studies where applicable;
  • Monitor data clean-up process performed by CRO’s from study start-up through data archiving;
  • Oversee provision of data for statistical analysis;
  • Manage activities including: medical coding; developing data validation checks and managing database snapshots;
  • Prepare and distribute project status reports to project team and management;
  • Function as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with SOP’s;
  • Create and maintain project documentation, including, but not limited to, Data Management Plan, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Design and modifiy CRF;
  • Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities;
  • Contribute to DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization;
  • Works with study team and coordinate all data management functions. Manage coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedure.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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