Clinical Data Manager - Swedish Orphan Biovitrum - Avslutad

The Clinical Data Manager role at Sobi is to support clinical studies and projects with data management skills all the way through protocol develop­ment, CRO selection, study conduct, database lock, clinical study report and submission. Because of the outsourcing of data collect­ion the Sobi CDM role is much focused on project management and close collaboration with CRO Data Management.

Key Responsibility Areas

  • Leadership and project coordination of all data management activities in project/study from protocol development to submission
  • Responsibility for quality and location of Sobi’s clinical data
  • Support clinical study teams through the evaluation of CROs during the outsourcing process, ensuring that the selected CROs DM processes are in agreement with regulatory requirements and Sobi standards
  • Input to relevant strategic study documents i.e. study protocol, case report form, statistical analysis plan
  • Work as a member of the joint Sobi and CRO Clinical Team to establish, communicate and deliver on a clinical data handling strategy documented in a Data Management Plan
  • Ensure data delivered to Sobi is in accordance with regulatory requirements and Sobi standards
  • Provide a level of expertise in data management overall within Sobi and contribute to developing internal DM processes and SOPs

Education

University degree in Life/Health Science/Computer Science or equivalent.

Experiences

  • Experience of data management in the biotechnology/pharma­ceuti­cal industry with a strong understanding of clinical trial data collection and clinical submissions
  • Experience working in a multinational environment and with external service providers (CROs)
  • Experience of computer applications in drug development, database systems and computer system validation (GAMP) is a plus.
  • Some familiarity with data conventions (CDISC SDTM), controlled terminology (CDISC) and common external coding dictionaries (e.g. MedDRA, WHO DD)

The right candidate need to master English in both oral and written communication. He or she must also be a collaborative person demonstrating ability to work in a team environment as well as showing strong individual initiative being able to work independently. The role holder shall have strong organisational skills as well as curiosity and drive to broaden skill and knowledge. Demonstrated focus on important details is also of importance.

Application and more information

Please call Knut Natt och Dag on +46 722 16 68 00 if you have any question. You are welcome with your application by e-mailing your CV and a personal letter to knut.nattochdag@aktivia.se as soon as possible. We are working continuously with this recruitment project and would like to receive your application as soon as possible. Write “Data Manager” in the subject field. 

Swedish Orphan Biovitrum is cooperating with Aktivia Science Work in this recruitment. Aktivia Science Work is a recruiting and consulting company within Life Sciences specialized in positions within the pharmaceutical industry – from early discovery through pharmaceutical development and clinical development to the market place. We are members of SwedenBIO and Medicon Valley Alliance. You can read more about us at or website – www.aktivia.se

  

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