Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

This role is hybrid - Based in Bucharest

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 departmentsEnsures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical suppliesEnsures proper administration of sites and vendors payments, as applicableEnsures regulatory and ethics committee submissions and notificationsCoordinates preparation for and follow-up on site, TMF and systems´ audits and inspectionsSupports the organization of internal team meetings including preparation of agendas and minutes, and also of Investigator’s MeetingsMaintains study-specific and corporate tracking systems

Document Management

Maintains Trial Master File (TMF)Performs TMF review and oversight at country and site levelPrepares, distributes, and updates Investigator Site Files (ISF) and ISF checklistsRevises and checks translation status

Safety Management

Ensures proper safety information flow with investigative sites

QualificationsCollege/University Degree (preferably Life Sciences)Proficiency in standard MS Office applicationsProficiency in EnglishGood organizational and planning skills, problem-solving abilities, and flexibilityDetail-oriented, able to multi-task and work effectively in a fast-paced environmentTeam-oriented with excellent customer service and interpersonal skills, including a positive attitude to tasks and projects

Additional Information

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.