Alexion Pharmaceuticals Associate Director, Project Management Country Operations in Boston, Massachusetts
Position Summary The AD Project Management Country Operations (AD PMCO) is responsible for the successful execution of study deliverables and the quality execution of high priority and/or complex protocol procedures through adherence to good clinical practices (GCP), evolving regulatory requirements, and ensuring quality and consistency of monitoring activities. The AD PMCO is accountable for coordinating rapid start-up activities across assigned countries together with the CRO. The AD PMCO will also drive adherence to timelines and milestones of study goals as well as identifying and communicating risks to the study team. The AD PMCO will ensure that the CRO assigned, FSP or in house CRA monitoring activities at study, sites results in the effective identification and problem solving of issues. Works with the CRO to revise study-specific country plans and timelines. Accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations Ensure that the studies assigned in the country are appropriately resourced. The AD PMCO will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocol-specific training. Attendance at site visits as required together with the CRO, FSP CRA or in house CRA as applicable or with Global Medical Affairs personnel for Sponsor Oversight, Inspection Readiness or Engagement Visits.
Job Accountabilities & Responsibilities
Reporting to the Head Country Operations the AD PMCO is
Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies)
Proactive reporting of study-specific issues (including monitoring metrics) to the study team via the Study Lead Country Operations (SLCO)
Quality of monitoring oversight in the country for assigned study(ies)
Meeting recruitment targets for assigned study(ies)
CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party)
Negotiation of site study budgets
Oversight of FSP and /or contingent workers on assigned study(ies)
Review if local regulatory documentation and oversight of local regulatory activities
Relationship management with the national coordinating investigator as applicable
Timely and accurate responses to queries from the study team
Working with Medical Affairs to coordinate site feasibility and engagement activities
Scheduling and leading effective country calls with the local study team and/ or CRO
Resolving ICF issues in-country
Oversight of EC submissions and facilitate the resolution of queries
Proposing potential investigator sites (HCO accountable for selection)
Conduct training of CRAs
Review of Clinical Monitoring Documentation
Inspection readiness activities
Relationship management with sites
Provide feedback to Internal and External Stakeholders as appropriate
Develop and maintain tracking tools
Drives quality efforts to proactively identify and manage risks to study quality
- Proven experience in the oversight and delivery of operational aspects of all stages of of clinical trial process
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.