Project Manager - Berlin, Deutschland - Oracle

Beschreibung

Job Scope:

Support the Principal Investigator

Co-leader of the Study Team

Manage the study according to epidemiological and medical standards within the timeframe and budget presented in the study protocol/contract

Ensure the study is successfully executed, from creating the study protocol until the final study report

– all within budget and time constraints

Obtain and manage resources to execute the study successfully

Primary Duties:

Coordinate internal resources and contractors for the flawless execution of projects

The creation and the approval procedure of the study protocol and the process in compliance with the SOP PM01 Study Protocols (cf. 'Project Management' section).

Organize the various professional people working on a project.

Provide study-specific training to internal and external study staff in compliance with the SOP ADM10 Investigator and Study Staff Training (cf. 'Administration' section).

Compile and submit documents to IRBs/ECs

Ensure that efficient study logistics are in place that are suitable for meeting the timelines and milestones agreed with the MAH and the Safety Monitoring and Advisory Council

Oversee the accounting, costing and billing of the investigation and managing the study budget

Inform the members of the Study Team regarding study-related information

First contact for the MAH and subcontractors

Career Level - IC3

University degree in relevant field

Excellent organizational skills

Experience in conducting epidemiological studies in multinational setting in the respective therapeutic/diagnostic area

Experience in protocol and report generation

Acknowledged team orientation

Strong communication, interpersonal and presentation skills