Site Management Associate I Bucharest

Site Management Associate I
Bucureşti
Bucharest, Bucharest, Romania

Job Description

Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.

Communication and Site Management

• Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team, and with other PSI departments
• Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
• Ensures proper administration of sites and vendors payments, as applicable
• Ensures regulatory and ethics committee submissions and notifications
• Coordinates preparation for and
  - up on site, TMF and systems´ audits and inspections
• Supports the organization of internal team meetings including preparation of agendas and minutes, and also of Investigator’s Meetings
• Maintains
  - specific and corporate tracking systems

Document Management

• Maintains Trial Master File (TMF)
• Performs TMF review and oversight at country and site level
• Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
• Revises and checks translation status

Safety Management

• Ensures proper safety information flow with investigative sites

• College/University Degree (preferably Life Sciences)
• Proficiency in standard MS Office applications
• Proficiency in English
• Good organizational and planning skills,
  - solving abilities, and flexibility
• Detail-oriented, able to
  - task and work effectively in a
  - paced environment
• Team-oriented with excellent customer service and interpersonal skills, including a positive attitude to tasks and projects

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.