Consider this role if you are an experienced Project Manager within Clinical Operation 

Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd^® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2 and 3 Type 1 Diabetes.

A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd^®. 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 the 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.

Key responsibilities

• Oversee and follow up on activities of the contracted External Service Providers (ESPs) i.e Clinical Research Organization (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.

• Primary contact with assigned counterparts at ESPs 

• Provide clinical study status updates and escalate issues to the Clinical Program Lead

Qualifications

• 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

Welcome to apply via haegercarlsson.com
Questions are answered by:

Lena Sörskog +46 (0)70-692 45 70, lena@haegercarlsson.com

Anna Freese +46 (0)76-174 75 81, anna.f@haegercarlsson.com