Trial Transparency Manager
il y a 7 jours
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 ClinicalTrials.gov 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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