Position: Site Management Lead Country Operations Germany (m/f/d)
Reports to: Acting Head of Country Operations (HCO) Germany
Location: This position can be remote/virtual, based in Germany (ideally close to an airport) and may require up to 70 % travel
The Site Management Lead Country Operations (SML) is accountable for overseeing outsourced (to CRO), FSP or in house CRAs (as applicable) including start up and monitoring activities to ensure the quality execution of protocol procedures, adherence to good clinical practices (GCP), evolving regulatory requirements and consistency of monitoring activities.
The SML is accountable for ensuring the CRO, FSP or in house CRAs monitoring study sites results in effective identification and problem solving of issues. Findings and solutions will be communicated to both Alexion and the CRO as applicable.
The SML supports the CRO staff, particularly CRAs as well as FSP or in house CRAs to understand complex protocol processes and procedures Job Duties & Responsibilities
Reporting to the Head of Country Operations (HCO) the SML is
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: .
Job ID: 22912
Job Area: Clinical Operations
Function: Healthcare - Other
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