If you are an experienced Clinical Trial Manager/Clinical Project Manager and looking for a position that also takes you beyond clinical operations - this might be something for you.

Haeger & Carlsson are recruiting a Clinical Trial Manager with several years’ experience to Diamyd Medical.

Diamyd Medical develops precision medicine therapies for Type 1 Diabetes. Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. The Company’s confirmatory Phase III trial, DIAGNODE-3, is actively recruiting patients with recent-onset Type 1 Diabetes in eight European countries and has started in the US. Significant results have previously been shown in a large genetically predefined patient group in a large-scale meta-analysis as well as in the Company’s European Phase IIb trial DIAGNODE-2, where Diamyd® was administered directly into a lymph node in children and young adults with recently diagnosed Type 1 Diabetes. A biomanufacturing facility is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the antigen-specific immunotherapy Diamyd®.

Diamyd Medical also develops the GABA-based investigational drug Remygen® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia.

Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB as well as in the artificial intelligence company MainlyAI AB. Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B.

As Clinical Trial Manager you will focus on project management and sponsor oversight. The tasks will be delegated by the Clinical Program Lead, and you will report to Chief Operating Officer. You will work closely with the Clinical Operation team but also with colleagues in other R&D functions. The office is based in Stockholm City.

• Oversee and follow up on activities of the contracted ESPs (CRO and other clinical vendors) to ensure that obligations are fulfilled. Identify change of scope when applicable
• Perform and document sponsor oversight activities, such as reviewing monitoring reports, tracking study metrics, review submission packages, follow up on deliverables from ESPs
• Support with writing and reviewing study specific documents such as CSPs, ICFs, monitoring plans, data management plan, risk management plan, study specific procedural manuals etc.
• Support regulatory activities
• Support safety management

• BSc/MSc from a relevant scientific field
• Broad experience as a Clinical Trial Manger or Project Manager and thereby able to work autonomous to a large extent
• Experience from working in phase II-III trials
• Good knowledge and understanding of clinical trials and ICH-GCP
• Medical and scientific writing skills
• Highly proficient in spoken and written English and Swedish
  

Please apply through Haeger & Carlsson
Questions are answered by:
Lena Sörskog +46(0)70- 692 45 70, lena@haegercarlsson.com
orJulia Erginöz +46(0)70- 864 77 17 julia@haegercarlsson.com
Apply