Clinical Trial Manager

Sector:
Pharmaceutical
Location:
Germany
Sub-location:
Any
Currency:
Job Type:
Any
Salary Description:
excellent
Posted:
30/07/2019
Ref No:
124277

We have an opening for a clinical trial manager to support development projects in phases I-III.

The role will focus on management and supervision of all processes and tasks related to clinical trials management, management of 3 rd parties suppliers and reporting all findings and results in compliant manner.

Tasks required:

Manage, implement, coordinate, and supervise all processes needed for clinical trial start-up, trial conduct and trial close-out from Sponsor’s perspective

Support trial centre and patient recruitment, take care of the cooperation with the trial centres being their central Sponsor contact person throughout the entire project

Contract management with trial centres and CROs as well as other external service providers

Supervise CRO and other external service providers performance with respect to implemented processes, quality, timelines, milestones and costs

Track and supervise trial budget and data quality

Data preparation and responsibility for the trail documentation and support the creation of presentations, trial documents and publications

Support audits at trial centres and external service providers

Work closely with internal functions such as medical affairs, regulatory affairs, pharmacovigilance, pharmacokinetics and external service providers (e.g., data management, statistics, monitoring, central laboratories)

Requirements:

University degree or experience in a medical profession such as Nurse

Knowledge of clinical trials management and operations

Prior experience in planning and conducting international clinical trials, preferably as Clinical Trial Manager, Project Manager or in a comparable position

Familiar with applicable local and international law and guidelines (e.g., ICH-GCP)

Familiar with EDC systems

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.

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