Site Management Lead Country Operations Germany (m/f/d)

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27.10.2020

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Site Management Lead Country Operations Germany (m/f/d)

Germany

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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

Position Summary:

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

accountable for:

  • Act as Alexion point of contact  for the site: develop and maintain productive relationships
  • Assessment of site  monitoring activities undertaken by the CRO personnel, FSP and in house CRAs and any requisite escalation 
  • Identifying any site and/or CRA performance issues, quality events or any other quality issues at the patient and/or site level 

responsible for:

  • Proactively oversee start up processes to ensure expeditious start up of studies within geographical remit 
  • Support interactions between Medical Affairs and site
  • Addresss protocol-related training gaps for FSP CRAs
  • Communicate clinical site assessment information to the Project Manager Country Operations (PMCO) and/or the CRA
  • Conduct Sponsor Oversight Site Visits (SOSV) to assess site and CRA performance 
  • Maintain tools ot document and track clinical monitoring activities
  • Supporting inspection readiness activities at the site level, with geographical remit
  • Support implementation of CAPAs as necessary
  • CRA resourcing across allocated studies 
  • Provide feedback to Internal and External Stakeholders as appropriate

Essential Qualifications:

  • Extensive site management and monitoring experience across a range of highly complex disease areas
  • Demonstrated capability of effective monitoring and site oversight
  • Solid knowledge of clinical development processes with strong emphasis on monitoring
  • Ability to lead, troubleshoot and influence for quality and delivery
  • A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
  • Proven experience in effectively communicating with site staff including and including KOLs and thought leaders
  • Experience in all study phases and in rare medical conditions preferred
  • Previous oversight and regulatory inspection experience preferred
  • Comprehensive and current regulatory knowledge, including GCPs
  • Experience conducting GCP or other training is a plus
  • Demonstrates flexibility in schedule and willingness to travel frequently in assigned region (required travel may be as high as 70% during busy periods) 
  • Good organizational skills and ability to deal with competing priorities
  • Effective communication skills (written, verbal and presentation)
  • Creative thinker, curious and unafraid to ask questions
  • Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
  • Proficient with MS Office Suite (Excel, Word and PowerPoint). 

Preferred Qualifications:

  • Bachelor’s Degree or equivalent in one of the disciplines relatd to clinical practice/health care, life sciences or drug development is required.  A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred
  • 5+ years of relevant experience with 3+ years of direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred

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

Industry: Pharmaceutical/Pharmacology

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