Sr. Manager, Global Clinical Compliance THV
Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: February 22, 2021
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Job Description:
We have made changes to enhance your experience. If you have
applied for a job previously, you will need to create a new
account. Thank you for your patience. Sr. Manager, Global Clinical
Compliance THV USA - California - Irvine The THV clinical
organization is a multi-functional team supporting the product
development lifecycle through groundbreaking clinical trial design
and execution from first in man through post market surveillance,
leading clinical evidence in THV worldwide. As the Sr Manager of
Global Clinical Compliance, you will lead the development,
implementation, and continuous improvement of Clinical Compliance
processes. Essential Job Functions/Key Responsibilities: -- ---
Develop and manage global comprehensive BU clinical compliance
processes and workflows to ensure clinical compliance in accordance
with regulatory and company requirements. ----- Lead internal
cross-functional compliance assessments focusing on adherence with
applicable global regulatory and company guidelines (e.g., internal
Standard Operating Procedures and Instructions, GCP, and best
practices.) Investigate and identify any risk areas within Clinical
Affairs (and Medical Affairs as applicable) and provide
recommendations for process improvements. ----- Identify, lead, and
provide global business improvement solutions for Clinical study
processes, including creating, reviewing, and recommend changes to
procedures and processes to improve operation, efficiencies, and
drive clinical compliance ----- Lead strategic discussions and
determine preventative actions on risk area(s) with stakeholders
while leading the implementation of broad and more complex
strategies, including advising internal and external stakeholders.
----- Develop appropriate corrective actions in partnership with
the cross-functional audit finding owners promptly in accordance
with applicable regulatory and company guidelines ----- Lead the
development and delivery of global training programs for
stakeholders (e.g, clinical groups and Clinical Compliance) on best
practices, trends, regulatory requirements and updates, and
published guidance, policy and procedure updates ----- Lead
compliance assessments of external research partners (e.g.,
research institutions, clinical vendors). Develop and lead the
global implementation of corrective action in partnership with
stakeholders (e.g., clinical research, vendor management, clinical
safety) ----- Develop a program for the ongoing review of external
regulatory audit findings (e.g., FDA warning letters, 483's, CAPA)
and conduct risk assessments and provide recommendations for
corrective actions ----- Develop training, coach, and guide team
members on highly complex clinical compliance procedures and
regulations ----- Provide recommendations, identify, gain buy-in
from, and present findings to senior management to support new
clinical compliance projects, initiatives, and/or programs.
Keywords: Edwards Lifesciences Gruppe, Irvine , Sr. Manager, Global Clinical Compliance THV, Healthcare , Irvine, California
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