Clinical Trial Assistant

Clinical Trial Assistant – Clinical Studies
(external contract – 1 year)

Purpose:
The Clinical Trial Assistant (CTA) contributes locally to the organization’s drive for business quality and efficiency by being responsible for facilitating and providing efficient study support and expertise to teams under the Clinical Development TEAM operating model in clinical studies.
CTA will collaborate with the dedicated country teams and other key stake holders for the trial initiation, conduct, and reporting of trial progress by coordinating and performing assigned development and operational activities.

YOUR TASKS AND RESPONSIBILITIES

- Prepare and/or coordinate the preparation of project / study materials for internal and / or with vendors such as:
- Creation and sending communications materials to study sites;
- Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return;
- Submission of EC documents for approval
- Coordination of communication of project/study status to various levels of management;
- Managing and maintaining study information documents & trial supplies;
- Support the team with ongoing conduct of studies, at all milestones.

- Organization, maintenance, reconciles and archiving of paper or/and electronic Trial Master Files (eTMF) and assistance with eTMF administrative support activities.
- Participate and support audits, inspections and verification of TMF.
- Maintain operational tracking and reporting systems and tools.
- Provide meeting coordination for the local clinical team members in scheduling agenda, presentations, minutes and action item tracking including global and regional investigator meetings, global/regional monitor training meetings (if applicable).
- Provide expertise in non-project activities.

WHO YOU ARE

• PROFESSIONAL EXPERIENCE: previous experience in the field represents an advantage
• EDUCATION: Student or graduated of relevant university
• Excellent communication and attention to details abilities
• Solid time management, prioritization, and organization skills
• Strong analytical skills
• Autonomy
• Team spirit
• Very good interpersonal skills, strong customer focus
• IT skills: MS Office
• Language skills: Local language and English fluently

THE OFFER:

• Opportunity to work in a researched based company with high ethical standards
• Dynamic and involving job;
• Opportunities for training and development;
• Company benefits package;
• Fixed monthly salary.

Application time: until 30 October 2020

Reference Code: Clinical Operations_CTA

Division: Bayer

Location: RO-Bucharest

Confidentiality is guaranteed! Only short listed candidates will be contacted!

Deadline for submitting applications: 30 October 2020