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Clinical Operations Excellence Lead
Location:
Boston, MA
Description:
The Clinical Operations Excellence Lead (COEL) is responsible for the operational implementation of the clinical QMS in a consistent, effective and efficient way within the Global Clinical Operations organization (Global Trial Operations, Data Management, Medical Writing and Global Sourcing & Alliance Management), in accordance with the global quality strategy. The successful candidate will excel in leadership and establishing good and effective internal and external working relationships and communication. Roles and Responsibilities: Ensure oversight of the adequacy of processes in Global Clinical Operations. Ensure regulatory requirements and commitments are reflected in the procedural documentsIdentify and drive continuous improvement of processes and systems within Global Clinical Operations organisationEnsure quality risk management principles are integrated in all Global Clinical Operations processes and systems in order to support compliance and ensure inspection readiness throughoutDrive the investigations and development of CAPA plans related to process-level non-compliances, audit and inspection findings, within the Global Clinical Operations organisationActively contribute to a feedback culture on non-compliance, CAPA, inspection and audit findings. Identify opportunities to share knowledge and expertiseActively participate in defining and monitoring compliance and quality metrics to ensure compliance oversight in Global Clinical Operations processes and projectsEnsure proper focus and prioritization of clinical process improvement activities by consistently applying Quality Risk Management and Quality-by-Design principles Identify and implement leading edge technologies and methodologies to enable quality by design of clinical study activitiesActive member of the Global Clinical Operations leadership team to ensure alignment across functions and regular review of the inspection readiness statusLead and/or contribute to cross-functional and/or cross-company initiatives aiming to increase quality and compliance, while decreasing reworkEnsure alignment with the QA organizationAct as interface between Global Clinical Operations and stakeholder organizations/functions in clinical developmentFoster co-creative working relations with partnering organizations such as QA, BIS, Clinical Development, GPS, GRA Skills and Competencies: Extensive experience of GCP/Pharmacovigilance quality management systems, applicable regulatory rules and guidelines, medical terminology, clinical trials, and drug developmentExcellent interpersonal negotiation and leadership skillsStrong written and verbal communication skills, acting globally in a culturally-diverse dynamic teamAbility to act independently and effectively prioritizeRoot Cause Analysis, CAPA Development and Risk Management methodology expertise Education, Experience and Qualifications: Bachelor's degree or University degree - medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experienceMinimum of 10 years of experience in Clinical and/or Pharmacovigilance Quality ManagementWorking knowledge of the relationship and regulatory obligations of pharmaceutical/biotech companies and CROsGlobal Strategic Drug Development experience#LI-RemoteAt argenx we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at XXXX@argenx.com . Only inquiries related to an accommodation request will receive a response.PDN-9bff9f6d-30c5-4309-bbe1-52c553c7da2b
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Clinical Operations Excellence Lead is a Other Jobs Clinical Operations Excellence Job at Argenx located in Boston MA. Find other listings like Clinical Operations Excellence Lead by searching Oodle for Other Jobs Clinical Operations Excellence Jobs.
Clinical Operations Excellence Lead is a Other Jobs Clinical Operations Excellence Job at Argenx located in Boston MA. Find other listings like Clinical Operations Excellence Lead by searching Oodle for Other Jobs Clinical Operations Excellence Jobs.