Clinical Trial Disclosure Manager

Clinical Trial Disclosure Manager

Sanofi

Budapest, Hungary

Join our global Clinical Sciences and Operation (CSO)’s Clinical Documentation department as a Trial Disclosure Manager (TDM) and you’ll ensure 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.

You will interact closely with clinical, statistics, regulatory, medical marketing, patents, and pharmacovigilance colleagues, to get the best solutions to specific public disclosure challenges on behalf of Global Business Units while ensuring timeliness and quality of deliverables. The working environment is undergoing constant evolution, and you can work with newest technologies.

Main responsibilities:

• Work with colleague TDMs, study and/or project teams in order to plan, prepare, and release registrations and results on specific website/s within the required timelines. You will also participate or lead activity in related process areas such as redaction of documents, preparation of summaries and management of public queries;
• Collaborate with colleagues and teams to drive resolution of specific disclosure challenges that may arise during product development and/or in relation to therapeutic specificities;
• Identify and follow-up CAPA in the event of deviations, for the assigned therapeutic or product areas;
• Supervise consultant and/or vendors on selected disclosure activity, ensuring in partnership the timely production of high-quality deliverables for Global Business Units or other Customers;
• Participate, contribute or lead selected quality, technical, and/or process-driven activities to ensure complete and timely follow up of the defined deliverables;
• Train or participate in delivery of selected training of colleagues, or Vendor, and similar communications;
• Have or develop knowledge of disclosure regulations, website standards, and company commitments/policy, and apply them to guide study, project teams, and colleagues.

About you

Experience:

• Understanding of or exposure to the clinical development environment;
• Clinical background, medical writing or regulatory submissions background will also be considered;
• Study management, clinical research or related skills desired although not essential.

Soft skills:

• Ability to summarize scientific information and edit text for specific audiences;
• Quality consciousness, attention to detail, and an inquisitive mindset;
• Comfortable with computer applications and ongoing innovations;
• Good sense of organization, prioritization, adaptability;
• Excellent interpersonal and ‘relational/oversight’ skills, team-player.

Technical skills:

• Good knowledge of MS Office Suite (Word, Excel, PowerPoint);
• Comfortable with computer applications and ongoing innovations.

Education:

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

Languages:

• With excellent English, to support efficient decision-making.

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