Senior Clinical Study Specialist

In the context of a brand new project, we are looking for a consultant to join us asap on the following missions :

Responsabilities

Assistant to draft and update key documents
Detect opportunities for improvement
Answers to Competent Authorities administrative questions, in order they can be finalized within expected timelines.
In charge of following the update of the whole Product Information for the Reference Summary of Product Characteristics for
Investigational Medical Products/ Auxilliary Medicinal Product(s)initially identified, by preparing summary comparative tables for Product
Information and submitting an impact assessment for validation.
Notification to the ANSM of New Event/Urgent Safety Measure
Regulatory surveillance for CTs on World Health Organization database
Participates in the preparation of any inspection relating to a CT in which you are involved
In charge of training the employees to European CT Regulation
To ensure execution and delivery of the study as defined by the protocol and according to agreed timelines, quality standards and CT budget
To oversee and steer the conduct of the CT from the early preparation until the final CT closure (i.e. from CTsynopsis to CTarchiving)
To identify and anticipate any deviations on CT deliverables and put in place action plans to minimize impacts
To provide adequate reporting to the Core Team
To define the optimal operational strategy
To provide technical and practical regulatory input/expertise regarding protocol and amendments writing
To coordinate IMPD volumes and other regulatory documents availability (Cover letter, EudraCT...)To coordinate answers to CAs’ questions by expert of each topic, and to make them available to the Study Team
To oversee the submissions to regulatory authorities

Profile

Education : Life science degree, pharmacist education is a plus
Strong knowledge of ICH/GCP guidelines or other relevant guidelines
Good understanding of Clinical trial regulation and the Clinical trial information system
Ideally EU / Global experience (around 5/8 Years)
Proficiency with computer systems
Strong verbal and written communication skills in English, any other language is a plus
Strong organizational, time management, interpersonal skills.
Team player spirit
Ability to work both independently and in a team environment

Publish Date

20 December, 2021

Spontaneous Application

Senior Clinical Study Specialist

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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