Alexion Pharmaceuticals Study Lead Country Operations in Boston, Massachusetts
This position can be based at any US Alexion office location, OR remote
The Study Lead Country Operations (SLCO) is the primary point of contact for the Country Operations (CO) team at the global study level and will act as a core study team member. The SLCO will be accountable for coordinating and driving activities performed by country operations including start up, monitoring, site oversight, quality, and specific study deliverables. The SLCO will, therefore, be involved in study documentation review, coordinating CO activities globally, and will act as a liaison for other key stakeholders for relevant site and monitoring issues at country level.
The SLCO be responsible for liaising with Country Operations personnel to conduct the feasibility process, providing feedback to the study team regarding potential site and patient numbers.
The SLCO is responsible for utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.
The SLCO may be required to visit sites with the CRAs (CRO, FSP or in-house as applicable), or with other Alexion personnel (e.g. CO, Global Medical Affairs, etc.) for Sponsor Oversight, Inspection Readiness or Engagement Visits.
Job Accountabilities & Responsibilities
Monitoring and site oversight globally assigned study(ies), representing the monitoring function on the Global Study Team
Aggregation and communication of deliverables for assigned study(ies), globally, to the Clinical Program Lead (CPL)
Resourcing and training of Functional Service Provider (FSP) CRAs for assigned study(ies) Validating local CRO resources, as necessary, to support execution of the study(ies)
Developing and/or reviewing applicable study documents including training materials and reports
Delivery of appropriate protocol and indication training to Country Operations teams
Coordination of start up and recruitment activities at the study level, across all countries
Ensuring deployment of inspection readiness measures: including preparation of tools and required documentation
Liaison between Country Operations (CO) teams and the Global Study Team: act as the central point of contact for the CO team for assigned studies
Standardization of study conduct and clinical monitoring processes across study(ies)
Collection of site nominations and communications thereof to the CPL
Track trends occurring within the study that may impact other studies and communicate to the SLCO team and other key stakeholders
Together with the SLCO team, standardize processes across the studies to improve efficiencies in CO activities
Define monitoring requirements including components of Risk Based Monitoring (RBM)
Support risk management and signal detection at a study level
Act as a Subject Matter Expert for Sponsor Inspections by Regulatory Agencies or during audits
Review quality metrics and provide solutions for continuous improvement
Maintain a thorough knowledge of disease area and protocols
Extensive clinical trial experience across a range of highly complex disease areas
Demonstrated capability of effective CRA and site oversight
Solid knowledge of clinical development processes with strong emphasis on monitoring
Track record of establishing effective relationships with investigator sites
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
Ability to travel as required internationally and domestically. Demonstrates flexibility in schedule and willingness to travel up to 25%.
Bachelor's Degree or equivalent in one of the disciplines related 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.
8+ years of clinical research experience in biopharma or CRO
Demonstrated project management skills across multiple highly complex clinical studies
Experience of managing multiple studies including extensive experience in the management and oversight of CROs
Experience of ultra rare disease clinical research is beneficial
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: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.