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Clinical Trial Disclosure Manager

Synthorx

Synthorx

Budapest, Hungary
Posted on Wednesday, September 13, 2023

Our position

  • Job title: Clinical Trial Disclosure Manager (TDM)
  • Location: Budapest-Hungary
  • Flexible working: 60% home office/week
  • Job type: Permanent, full-time

About the job

Our Team:

In a context of increasing regulatory requirements worldwide and growing public expectations about clinical trial transparency, the Trial Disclosure Manager in the Clinical Documentation department ensures timely public disclosure of protocol information and study results, in line with regulatory requirements and Sanofi data sharing commitments. High attention to detail is needed due to externalization of company information and commercial sensitivity during product development, with strong summarizing skills. The TDM will interact closely with clinical, statistics, regulatory, medical marketing, patents, and pharmacovigilance colleagues, in order to get the best solutions to specific public disclosure challenges on behalf of Global Business Units while ensuring timeliness and quality of deliverables.

Main responsibilities:

  • Works with colleague TDMs, study and/or project teams, to plan, prepare, and release registrations and results on appropriate website/s within the required timelines. As well, participates or leads activity in related process areas such as redaction of documents, preparation of summaries, management of public queries and others.
  • Collaborates with colleagues and teams to drive resolution of specific disclosure challenges that may arise during product development and/or in relation to therapeutic specificities.
  • Identifies and follows up corrective action and preventive action (CAPA) in the event of deviations, for the assigned therapeutic or product area/s.
  • Supervises consultant and/or vendor/s on selected disclosure activity, ensuring in partnership the timely production of high-quality deliverables for Global Business Units or other Customers.
  • Participates in / contributes to / leads selected quality, technical, and/or process-driven activities in order to ensure complete and timely follow up of the defined deliverables.
  • Trains or participates in delivery of selected training of colleagues, or Vendor, and similar communications.
  • Has or develops knowledge of disclosure regulations, website standards, and company commitments / policy, and applies them appropriately in order to guide study, project teams, and colleagues, through appropriate communications.

About you

Experience:

  • Understanding of or exposure to the clinical development environment.

Soft Skills:

  • Ability to summarize scientific information and edit text for specific audiences.
  • Able to run working groups for large audiences.
  • More exposure to independent work and backgrounds.
  • Strong communication skills- effective speaking skills.
  • Quality consciousness, attention to detail, and an inquisitive mindset.
  • Good sense of organization, prioritization, adaptability.
  • Excellent interpersonal and ‘relational/oversight’ skills, team-player.
  • Ability to solve problems- solution led.
  • Demonstrate leadership approach.

Technical skills:

  • Study management, clinical Research or related skills desired although not essential.
  • Clinical background medical writing or regulatory submissions background will also be considered.
  • Comfortable with computer applications and ongoing innovations.

Education:

  • Scientific life-science or related background (master’s degree, PhD or equivalent).

Languages:

  • Excellent English, to support efficient decision-making.

When joining our team, you will experience:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
  • An attractive, market-oriented salary and cafeteria benefits.
  • Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days.
  • Work from an "Office of the Year 2020" finalist office.
  • Collective life and accident insurance.
  • Yearly medical check-up.
  • An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks.
  • Your own career path within Sanofi. Your professional and personal development will be supported purposefully.
  • Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs).

Pursue progress. Discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

#Sanofi

#WeNeverSettle

#SanofiCareers

#joinsanofi

#careerswithpurpose

#CSOBudapest

#clinicalsciencesoperations

#SanofiBudapestHub

#pursueprogress

#discoverextraordinary

#LI-EUR

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.