Trial Transparency Manager

il y a 2 semaines


Paris HôteldeVille, Île-de-France Cmed Temps plein
Cmed is seeking an EU based Trial Transparency Manager with disclosure and transparenct expreince for this client dedicated opportunity.

Responsibilities:

Drives the processes for assigned portfolio/s of disclosure activity (eg, therapeutic or regulatory area/s, vendor coordination) that result in timely, high-quality information posted on public websites, tracked appropriately

Works with study and/or project teams, ie, clinical, biostatistics, regulatory, marketing, patents and legal, to plan and prepare registrations and/or results for varied websites, according to current guidelines

Brings specialized knowledge of global disclosure requirements and standards to teams, in association with a scientific background, providing guidance on best practices to ensure quality of information shared publically, and compliance with defined requirements

Drives a strong focus in teams and partners on consistency of trial/product information across disclosures and associated areas such as publications and data-sharing

Provides careful oversight of activities managed in collaboration with Vendor partners

Understands data-sharing requirements and their relationship to trial disclosure

Due to the rapidly evolving nature of the disclosure landscape, leverages self-study, ongoing learning, etc. to remain abreast of developments in trial disclosure and related fields

Works effectively with disclosure and disclosure relevant tools used by the Platform

Depending on experience, may mentor more junior staff members and provide SME representation in varied disclosure-related projects both internal and transversal

Participate in or lead process improvement initiatives for disclosure

Required Education/Experience

Bachelors' degree in life sciences

3-5 years of experience in disclosure

Experience preparing clinical regulatory documents and/or experience in summarizing scientific information

Understand global regulatory requirements for clinical trial disclosure

Has working knowledge and familiarity with and EudraCT

Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.

Detail-oriented with excellent inter-personal and communication skills.

Ability to work effectively with a document management system and planning and tracking system.

Ability to work both independently and collaboratively with a team in a cross-cultural and geographically dispersed environment.

Excellent written and spoken English

Strong communication skills and ability to deliver clear messages to varied audiences

Demonstrated leadership, problem-solving, ability to work simultaneously on multiple projects, and ability to prioritize tasks

Preferred Education/Experience

Advanced degree (e.g., Masters or Ph.
D. in life sciences)

Project Management

Specific knowledge of company-targeted therapeutic area/s is strongly desirable.

Familiarity with applied biostatistics

Experience working on Sharepoint
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