Job description

Clinical Affairs Lead

United States

Job Title: Clinical Affairs Lead

Employment Status: Full Time, Permanent

Practice:  RAQACA

Location: US Based Remote, with travel within US and UK (Approx 25-50% travel depending on business needs)

Salary: Competitive

Company:                                            

Do you want to make a difference while advancing your career? Come join Osler.

We are a UK diagnostics company whose purpose is to enable anyone, anywhere, to access, understand, and act on their health, to live healthier, happier, and longer lives.

We are realising this through the development of the Osler Origin – a 'portable lab' capable of performing a wide range of testing, with lab-quality performance, in a portable, rapid, low-cost, and easy-to-use manner. The Osler Origin will offer a wide portfolio of diagnostic tests and serve all major healthcare settings, globally.

The Osler Origin is powered by a portfolio of novel techniques and approaches for sample addition, microfluidic sample preparation, and electrochemical biosensing, and Osler was formed out of the University of Oxford in 2017, following decades of research.

Having recently completed an $85m Series C fundraise, we are now entering a growth phase, where we are scaling our team as we take the Osler Origin product through regulatory activities, and towards market launch.

Join us and help build a better future.

About the role:

You will have responsibility for supporting development of clinical strategy, clinical plan and associated clinical protocols/reports.  The role will have responsibility for initiating, developing, and maintaining liaison among physicians/investigators, other applicable medical professionals including Contract Research Organizations (CRO's), hospitals and research institutions to manage clinical trials/Registries from initiation through completion. 

You will have responsibilities for the clinical aspects of IVD medical device projects through all product life cycle, clinical affairs activities, and special projects.

Main responsibilities:

  • Support the development of clinical strategy and clinical plan.
  • Select Clinical consultants and Clinical Research Organizations (CROs) and manage their contracts and activity.
  • Recruit, hire, train, manage Clinical staff and their career development (Future).
  • Prepare and track Clinical budget.
  • Allocate resources and budgets to various department projects and oversee their progress.
  • Participate in preparation of Clinical operating plans and objectives in alignment with company and department strategies.
  • Supervise and implement clinical programs and track their progress.
  • Oversee the planning of new clinical programs and the development of clinical protocols.
  • Author, review and approve submissions of protocols and reports to the relevant regulatory authorities and Institutional Review Boards (IRBs) or Ethics Committees (ECs).
  • Interact with Investigators and IRBs on financial and compliance issues.
  • Oversee the proper collection, analysis, and presentation of clinical data.
  • Review and approve final Case Report Forms, Edit Checks and Clinical Study Databases.
  • Create and maintain department SOPs.
  • Assure compliance of department activities to the relevant regulations, department SOPs, and corporate requirements.
  • Develop and manage the process for clinical regulatory document preparation and submissions for clinical studies (IRB/EC submissions, etc.)
  • Author, oversee and/or review Clinical Evaluation Plans, Clinical Evaluation reports, Post Market Clinical Follow Up plans and reports, SSCPs and any other clinical documentation required for continued CE Marking.
  • Ability and willingness to travel to sites within US and UK and visit the head office in Oxford, UK 1 in 8 weeks.

Skills, Experience, & Attributes

Essential

  • Bachelor’s degree in science or health-related field.
  • Experience in the IVD medical device industry.
  • Experience conducting and managing IVD clinical studies.
  • Strong knowledge of Good Clinical Practice (GCP) requirements/guidelines.
  • Strong knowledge of FDA regulations and International Conference Harmonization (ICH) clinical study requirements.
  • Strong knowledge of European clinical study requirements.
  • Experience in writing Clinical documents.
  • Ability to independently lead clinical research.
  • Ability to develop clinical strategies and a strategic approach.
  • Strong communications and collaboration skills.

Desired

  • ACRP or SoCRA certification.
  • Master’s degree in science or health-related field.

 

 

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Join us and build a better future.