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R&D Operations

Trial Management and Regulatory Affairs Specialist (TM&RS)

  • 标题 Trial Management and Regulatory Affairs Specialist (TM&RS)
  • 功能 R&D Operations
  • 子功能 Clinical Trial Support
  • 类别 Experienced Analyst, Clinical Trial Support (P5)
  • 工作地 Bucharest, Bucuresti, Romania
  • 发布时间
  • 申请ID 2406190439W
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描述

Trial Management and Regulatory Affairs Specialist (TM&RS)

Location.: Bucharest, Romania

Full time job 

TM&RS is responsible for supporting the Global Clinical Operations (GCO) local country team, ensuring regulatory compliance in particular, while also providing operational support to ensure efficient management of trial-related processes and documentation.

Principal Responsibilities:

- Operational Trial Management:

- Provide comprehensive support to the local GCO roles/functions, including office management, financial oversight, and vendor coordination;

- Manage financial reporting through corporate systems and handle non-investigator related payments, contracting, and purchasing;

- Collaborate with local study teams on investigator payments and financial requirements;

- Serve as the Local Archiving Coordinator, overseeing archiving activities, maintaining documentation, and liaising with the Records Manager;

- Support training of new employees in finance, expense reporting, archiving, and destruction;

- Coordinate safety reports distribution;

- Manage travel-meeting organization for clinical trial-related activities;

- Comply with requests from Quality Assurance (QA) and auditors;

- Perform periodic TMF checks, as needed/applicable.

· Regulatory Affairs:

- Oversee the collection of Clinical Trial Application documents and prepare submission packages;

- Communicate with Regulatory Authorities/Ethics Committee, and internal and external stakeholders regarding submission procedures and requirements;

- Maintain expertise in local and EU clinical trial regulations and recommend modifications to local procedures;

- Administer insurance and sponsor document activities;

- Continuously suggest improvements to local procedures related to regulatory compliance.

  • Management of CTA Group:

- Provide coordination and day-to-day support to Clinical Trial Assistants (CTAs);

- Act as a mentor for new CTAs and provide training and support;

- Participate in CTAs' onboarding, training sessions, and discussion forums;

- Collaborate with other local departments and trial teams in relation to CTA scope of work.

Please note that this job description provides a summary of key responsibilities and qualifications. Additional tasks and duties may be assigned based on specific project needs and organizational requirements.

资格

Qualifications:

- Bachelor's degree or equivalent in a relevant field;

- Solid understanding of the drug development process, ICH/GCP guidelines, and local regulatory requirements;

- Previous experience in clinical operations, regulatory affairs, and administrative support within the pharmaceutical or clinical research industry;

- Strong organizational, communication, and interpersonal skills;

- Proficiency in Microsoft Office applications and other relevant software packages;

- Fluency in both the country language and English, with excellent written and oral communication skills.

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