Clinical Affairs Lead

Posted Date: 27-Jul-2022

Location: Chicago, IL, US, 60607

Company: Quotient

CLINICAL AFFAIRS LEAD

                                         

Quotient are recruiting for a Clinical Affairs Lead to join their Scientific and Medical Affairs Team. This is a remote working role with some travel across the US. The position is full time, permanent, with flexible working hours. The primary objective of the Clinical Affairs Associate is to lead and manage the conceptualisation, planning, design, execution and monitoring of multiple clinical field trials required as part of the licensing and registration of the medical device instrument and consumable products in development by Quotient.

 

JOB DESCRIPTION
The main responsibilities will include:

  • Responsible for leading the planning and management of assigned Quotient clinical field trials related to MosaiQ including management of potential Contracted Research Organizations field trials in foreign countries.
  • Leads site co-ordination, initiations, monitoring visits and close out visits as required.
  • Develops and reviews clinical case report forms, final reports, clinical investigator brochures and clinical trial protocols.
  • Responsible for the completion, compliance and assessment of safety / efficacy reports as required by the FDA and international regulatory bodies, clinical development plans, and research strategies.
  • Collaborates with Finance team to negotiate and execute investigator agreements and administer contracts.
  • Collaborates with the Sales team, providing visibility of trial status.
  • Prepares & reviews monthly reports and project updates for submission to management.

 

QUALIFICATIONS & EXPERIENCE REQUIRED

  • Relevant Degree or professional qualification is essential e.g., Scientific or Medical Technology. Clinical Affairs Professional Society Certification is desirable.
  • Significant experience (approx. 5-10 yrs) in a lead clinical affairs role with specialist knowledge of clinical affairs applied to in vitro diagnostic medical devices.
  • Must have a working knowledge of ISO 13485 and IVDD requirement. Experience in filing BLA, 510(k) and BLA/ PMA submissions, CE marks is desirable.
  • Understanding and experience of working in a regulated manufacturing environment (GMP, GDP, GLP).
  • Has the ability to manage and motivate team members.
  • High degree of technical competence with strong team working and project management skills.
  • Confident and customer focused with strong verbal and written communication skills.

 

ADDITIONAL INFORMATION

  • Competitive salary on offer with range of company benefits including healthcare, 401k plan and various insurances.
  • Up to 25-30% travel across US, with occasional European Travel.


Nearest Major Market: Chicago