Clinical Study Manager

il y a 1 semaine


Brussels, Belgique Thermo Fisher Scientific Temps plein

**Who is PPD Clinical Research Services?**

PPD is a leading global contract research organization. Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers. PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine

**The PPD FSP Solution**:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

The CSM is responsible for all operational aspects of the assigned clinical studies from initiation till closure. The CSM will have clinical study operational experience in phase I, II and III drug development phases and is an operational expert in the clinical study activities from start-up, execution until closure and its underlying activities. The CSM will be the “operational clinical study voice” for the assigned studies, both internally and externally, he

The CSM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure. The study responsibilities include:
Responsible for leading, guiding and overseeing the CROs and responsible for overseeing vendors involved in the assigned clinical studies based upon metrics and plans
Leading CRO contracts negotiations together with the Director Vendor Management
Providing input into and/or developing study related materials such as Clinical Study Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, Patient Information and Informed Consent, site instructions for specimen collections, and study drug order forms etc.
Ensuring that study Trial Master File is maintained and up to date
Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations
Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns

**Education and Experience**:
Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study

Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, eCRF databases)

Bachelor’s degree or University degree - medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience

Minimum of 5 years of experience in Clinical Operations and managing CROs and vendors

Biotech experience is a plus

**kidney disease / nephropathy** clinical study background

**Our 4i values**:

- Integrity - Innovation - Intensity - Involvement

**Work Environment Requirements**:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
- LI-MP1


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