Senior Clinical Trial Administrator

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 2,300 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Site Management/Other Communication:

• Exchanges data, documents and other project relevant information between investigative sites, site vendors and project team
• May assist with clinical supplies (including medication) order, receipt, inventory storage, distribution, return/recall and reconciliation
• Supports CA submissions and notifications; when given PC role, coordinates this process
• Assists with handling financial and contractual tasks; when given PC role, coordinates this process
• Under supervision, assists with preparation and follow-up of site, and systems´ audits and inspections
• Exchanges data, documents, and other information with the project team, other departments and vendors
• Provides assistance with organization of internal team meetings
• Prepares draft agendas for, and minutes of, internal team meetings 
• Under supervision, may prepare draft agendas for, and minutes of, project meetings
• Maintains study-specific and corporate tracking systems

Training

• Under supervision, may be involved in on-the-job coaching of CTAs
• Assists the PM with the overview of project-specific training compliance of the study team members

Document Management

• Maintains Trial Master File (TMF)
• May perform TMF review and oversight at country and site level; when given PC role, prepares TMF checklists
• Under supervision, assists in preparation and follow-up of TMF audits
• Prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklists; when given PC role, coordinates this process
• Provides assistance with translations; when given PC role, supervises and coordinates this process

Additional Responsibilities:

• Assists/coordinates the safety information flow within the project team, and between investigative sites and the project team
• May be assigned as Project Assistant or, under supervision, Project Coordinator. If assigned as a Project Coordinator, the Clinical Trial Coordinator job description will apply.
• Provides administrative assistance with feasibility research
• May be involved in the development of practices and training initiatives related to project administration at a regional level

Qualifications

College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient. Minimum of 12 months´ experience as Clinical Trial Administrator II at PSI, or a similar position in clinical research.

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. You will lead dedicated startup teams and work closely with cross-functional experts to drive your startup projects forward.