Licensing Project Manager

Licensing Project Manager

Bucharest, Romania; Iasi, Romania; Remote - Romania

Suvoda is a global clinical trial technology company shaping digital experiences that enable clinical trial sponsor and site professionals to take full command over the inherent logistical complexity behind mission-critical and time-sensitive patient interactions in life-sustaining studies for therapeutic areas such as oncology, central nervous system, and rare disease.

Supporting clinical trials means supporting unique experiments that are inherently complex, high-stakes, and dynamic. It is imperative that Suvoda staff working with clients, end-users, or the systems that client and end-users interact with understand the clinical trial industry, regulations, Suvoda's software products and processes, and especially the specificities of the unique trial in question before taking any actions they may alter the data of the system in question.

Responsibilities:

• Manage communication between Suvoda's internal eCOA teams and instrument developers/license holders for questionnaires;
• Manage communication between Suvoda's internal Technical Solutions and Design teams and 3rd party translation vendors regarding development needs and client translation requirements;
• Research license, translation, and eCOA requirements including layout, formatting, and appearance on devices. Determine the license holder is and how to get in contact;
• Take ownership over the development of information gathering form to be collected at project outset to assist in license research;
• Communicate and implement all translation and eCOA requirements, and timelines to correct internal eCOA teams;
• Design, manage and update internal reference master guide as needed with license holder requirements for future reference;
• Coordinate license holder reviews, as needed;
• Supply translation vendor with English.json files and screen reports for translation;
• Receive translated.json files from translation vendor and provide to the Technical Solutions team for implementation;
• Create screen report documents for each questionnaire by copying and pasting individual screenshot images of each question for a particular questionnaire. The individual screenshot images will be generated by the Technical Solutions team;
• Perform a basic proofread of the screen report documents to ensure all required screen content is present and in the correct order;
• Coordinate revisions to the screen report documents and.json files between the Technical Solutions team and translation vendor, as needed;
• Collaborate with Lead Project Managers regarding translation timelines in order for Lead Project Managers to communicate this information to the client;

Requirements:

• 2-3 years of experience in pharmaceutical industry;
• Strong licensing experience;
• Bachelor's degree required;
• Strong interest in language, research and desire to join the pharmaceutical industry;
• Experience in management of multiple simultaneous projects;
• Ability to multitask;
• Strong organization and detail orientation skills;
• Self-motivated;
• Professional communication skills;

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