Senior Clinical Scientist

Senior Clinical Scientist

Job Type: contract
Sector: Clinical
Region: East Coast
Location: Pennsylvania
Posted: 12th July 2019
Ref: WB12072019

My client is currently recruiting for a contract Sr. Clinical Scientist, on a full time contract basis. The successful candidate will provide scientific leadership for oversight and development of clinical studies. The candidate will also support drug development projects, including the planning and implementation of global clinical research programs across all phases.

Key Activities:

  • Supply scientific and technical leadership for successful study-related documents and correspondence, ensuring accordance with relevant SOPs and compliance to regulatory review
  • Coordinate with clinical supply personnel to ensure adequate clinical supply availability
  • Contribute and author documents for IND/NDA/CTA and other regulatory documents (e.g. briefing documents, protocols, IBs)
  • Co-lead Clinical study team meetings, and represent the Clinical function for the Project Team
  • Communicate study progression and deliverable to the Project team or senior management
  • Provide a platform of support for juniors, including study-related training and respond to protocol-related questions
  • Liaise with data management on data capture development, including case report forms and other activities to ensure adequate data capture
  • Provide input vendor selection and management, as well as on site selection activities ensuring selection of qualified investigators to meet the study objectives

 

Requirements:

  • Clinical Scientific Lead across all phases of Clinical Trials
  • Experience in working directly with cross functional teams including; Clinical Operations, Data Management and Bio statistics Teams
  • Ability to progress from Concept Development to Proof of Concept
  • 505b2 NDA Experience
  • Experience in CSR, CTD Modules 4/5
  • Journal article abstract/manuscript writing.
  • Clinical Pharmacology knowledge/experience
  • At least 5 years of experience in the clinical sciences within Industry
  • Working knowledge of all relevant regulatory guidelines and standards (e.g. GCP, ICH, and FDA/EMA Guidance documents), as well as practices and expectations of Quality within GCP

This opportunity is on a part remote basis, in office 3 days out of 5 in Pennsylvania.

About Your Consultant

Email: WBackshall@barringtonjames.com Telephone: +1 646 415 8221

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