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Job Details

Global Clinical Trial - Submission Specialist

Company: Clintec
Location:
Reference: BE-GCT-06112017-SK
Closing Date: 20 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Planning, coordination, preparation and tracking of the documents needed for initial submission Start-up) and Substantial amendments (ongoing) of Clinical Study package for all countries (except US) in compliance with the Country Regulatory Requirements, EU clinical Trial directive, related Guidance, and the client processes.

Requirements:

Global Clinical Trial - Submission Specialist

Department Title and Description

Global Clinical Trial - Submission

Planning, coordination, preparation and tracking of the documents needed for initial submission Start-up) and Substantial amendments (ongoing) of Clinical Study package for all countries (except US) in compliance with the Country Regulatory Requirements, EU clinical Trial directive, related Guidance, and the client processes.

Purpose/Objective of the job

Creation and collection of the submission documentation and compilation of the core dossier for an application to Competent Authorities (CAs) and/or Ethics Committees (ECs) to start, conduct and close a client sponsored Interventional Phase I – Phase IV clinical study in any of the countries client or collaborative partners targets to conduct the study in, except the US.

Key Responsibilities and Major Duties

  • Determine the appropriate submission strategy and consistency of the Clinical Trial Application (CTAp) across projects, studies and countries.
  • Effectively Lead Clinical Trial Application Tracking Meetings for the preparation of the CTAp dossier during start-up with cross-functional team and assure timelines and dossier quality are managed according to expectations.
  • Liaise with local and central teams and CRO, as required, to ensure that study start up activities are in compliance with study timelines and local regulations.
  • Optimally compile and distribute the final Clinical Trial Application dossier (CTAp) and subsequent Substantial amendments to country applicants for submission to Ethics Committees and Competent Authorities.
  • Communicate information and escalates issues, liaise with country offices and CSO, Operation Leads, Protocol Managers, Medical Monitor, QP and CROs (for outsourced studies) to ensure that study start up activities are in compliance with study timelines, Client SOPs, local regulatory guidelines and regulations.
  • Comply with the use and maintenance of the available planning & tracking tools (e.g. IRIS - HA submission and approval Tracking system) to generate reports and track the CTAp content and associated dates.
  • Ensure Compliance with any revised Guidance & Regulations at EU and Country levels.

 

 

Experiences/ Knowledge Desired

  • Experience in Clinical Trial Application preparation and coordination, regulatory or equivalent in the pharmaceutical industry.
  • Demonstrated success in using oral and written communication and presentation skills to influence, inform or guide others.
  • Experience in effective implementation of clinical plans/documents and document preparation.
  • Previous experience working in an international team environment within a matrix organization.
  • Experience in planning and coordination of study initiation.
  • Knowledge equivalent to that attained with a Bachelor's degree in Life Sciences, Allied Health, Pharmacy, Nursing ,a Master's degree is preferable, and 2-4 years of clinically related or relevant experience.
  • Thorough understanding of ICH-GCP guidelines and local regulatory guidelines or regulations as they apply to protocol/site management.
  • Knowledge of general clinical research including project management issues, important milestones and strategies to ensure timelines are met.
  • Knowledge of the pharmaceutical industry and of the pre-clinical, clinical, regulatory and commercial components.
  • A detailed understanding of project planning and management methods.
  • Thorough understanding of the drug development process and the impact of the European Clinical Trial Directive on Client policies and procedures.
  • Proficient use of ECLIPSE and related systems i.e. entry and study management functionalities.
  • Capability to define process flows and procedures, to modify and improve them when and where necessary

Apply for this job: Global Clinical Trial - Submission Specialist

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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