Clinical Data Manager

Clinical Data Manager

Would you like to be part of a growing Swedish biopharma company?
Hansa Biopharma is a fast-growing biopharmaceutical company developing novel immunomodulatory enzymes for transplantation and acute autoimmune diseases. The lead product, Imlifidase, is a proprietary antibody-degrading enzyme currently in late-stage clinical development for kidney transplant patients, with significant potential for further development in other solid organ transplants and in acute autoimmune indications. The company also has a strong pipeline of preclinical projects that may provide a second wave of potential drugs.

The role
In the role as Clinical Data Manager you will be involved in all the data management activities of our clinical studies, working closely with the clinical team.

You will be involved in several projects and studies simultaneously and report to the Director of Clinical Operations as well as to the respective project manager for project activities.

By being a part of our cutting-edge research, you will be making a tangible impact for patients as well as being part of the exciting journey Hansa Biopharma has embarked upon. The role will give you the opportunity of broadening your area of expertise.

The role includes the following responsibilities
  • To lead data management activities in close collaboration with Hansa Biopharma´s clinical trial and submission teams
  • To be the main point of contact for CROs concerning all data management activities including CDISC tasks (CDASH, SEND, SDTM and ADaM including CRT packages)
  • To continuously review and check data to maintain an overall control, using program checks, of both safety and efficacy data, in all clinical studies
  • To support SAP-deliverables from CRO, including, listing, tables and figures output, aligning all clinical studies within a project
  • To develop and drive alignment of data standards and data collection within Hansa Biopharma, i.e. documentation, testing and implementation of both clinical and non-clinical data
  • To review data management and programming deliverables from CRO´s including:
- CRF
  • Database set-up
  • SDTM, SDRG, annotated CRF and define
  • Data MGMT Plans, Reports and other relevant documents
  • ADaM, ADRG and define files
  • TLFs
Qualifications for the role
  • A degree within computer science, statistics or other similar qualifying education/experience
  • Knowledge of CRF design and database set-up process (eCRF)
  • CDISC experience including hands on knowledge of creating
- SDTM and/or SEND incl all deliverables for a CRT package
- ADaM including all deliverables for a CRT package
  • Understand the need of high-quality data of both clinical and non-clinical content of regulatory submission/documents
  • Good knowledge of FDA requirements
  • HAnds on knowledge of SAS programming
  • Experience of checking and filing eData
  • GCP experience
  • At least 5 years of experience from working in the industry with similar tasks
  • Preferable, scientific knowledge or keen on learn to understand the science behind the data
We offer
  • A position in a company that makes a difference today; in completed and ongoing clinical studies, the Hansa Biopharma lead candidate imlifidase has enabled kidney transplantation in highly sensitized patients with chronic kidney disease.
  • An opportunity to be part of the journey during which Hansa Biopharma aims to bring lifesaving products to the market.
  • A creative and positive atmosphere
  • Friendly, motivated and skilled colleagues
Application
Please send your application, including CV and cover letter, as soon as possible as we will review applications continuously. The last day for applications is April 22nd, but can be shortened.

For questions regarding the position and the process, please contact Elisabeth Sonesson, Director of Clinical Operations, elisabeth.sonesson@hansabiopharma.com

We are looking forward to receive you application!
Mer info
Område Lund
Yrkesroll Organisation & ledning, Chefsbefattningar, Data & IT, Databasadministration
Typ av anställning Heltid, Tillsvidareanställd
Sista ansökningsdag 27 maj 2019 (36 dagar kvar)
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Om arbetsgivaren

Hansa Biopharma is a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases. The Company's lead product, imlifidase, is a proprietary, antibody-degrading enzyme in late-stage clinical development for kidney transplant patients, with the potential for further development in other solid organ transplantation and acute autoimmune indications.

Hansa also has a strong pipeline of preclinical projects, including NiceR, through which the Company is developing novel immunoglobulin-cleaving enzymes for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden, and its shares are listed on NASDAQ Stockholm (HMED).