Clinical Safety and Regulatory Compliance Manager

1 day left

Recruiter
Morgan Jones
Location
Sandwich
Salary
,
Posted
21 Jun 2019
Closes
19 Jul 2019
Contract Type
Permanent
Hours
Full Time
Sandwich
GBP100,000 - GBP135,000 DOE
Benefits Package
Our client, a national medical device specialist, is looking for a Clinical Safety and Regulatory Compliance Manager EU/UK to join them.
This role is responsible for managing all clinical safety activities for a Global Clinical program.
This will include reporting safety events in the EU/UK, communicating with EU/UK regulatory authorities and providing regulatory document support to notified bodies.
Working closely with the Global Clinical and Regulatory team (Headquartered in USA) this role reports directly to the VP.
Overview of Duties & responsibilities:
  • Support timely submission of all clinical regulatory documents to ethics committees and regulatory authorities as required.
  • Contribute to the development of a global safety database.
  • Collaborate with Study Managers and Clinical Research Associates to ensure comprehensive safety information is available and translated for full review, coding and reporting.
  • Ensure timely reporting in compliance with MEDDEV regulatory guidance documents.
  • Collaborate with the Global Clinical Safety team on the coding of adverse events in an electronic database system with query generation as needed; and query reconciliation through partnering with the Clinical Affairs team and the study sites.
  • Assist with new clinical study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.
  • Evaluate clinical data and contribute to annual, interim and final reports of clinical information.
Requirements:
  • Minimum of a Bachelors' degree, health related or other scientific discipline; Advanced degree (MD, DVM) preferred.
  • Minimum of 3-5 years cardiovascular industry and global clinical trial experience
  • Knowledge of clinical trial and regulatory process required, including FDA, ICH, MEDDEV Guidance and ISO Regulatory Processes.
  • Ability to work cross-functionally and across time zones.
  • Self-motivated with excellent time management skills.
  • Ability to demonstrate competence and credibility to build relationships of trust with DSMB, CEC, CROs, physicians, statisticians and research staff at clinical sites.
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