Clinical Trial Disclosure / Transparency Manager

Job description

The Clinical Trial Disclosure / Transparency Manager (TTM) is a key member of the global Trial Transparency team in the Clinical Documentation department, CSO Platform. The TTM is responsible for overseeing or carrying out operations which together result in timely and complete disclosure of Sanofi trial information on publically accessible websites. Trial Transparency deliverables will meet the disclosure requirements of Health Agencies, Industry Associations, and the Sanofi company transparency commitments, all of which evolve regularly.

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
·  Proficiency with Microsoft Word, Excel, Power Point, and other Office applications

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

Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.