Project Manager (m/f/d) with CTS experience
Posted on Apr 15, 2019 by CSM Clinical Supplies Management Europe GmbH
NEW CHALLENGES. NEW
Our growing company is currently seeking a highly motivated and enthusiasticPROJECT MANAGER (m/f/d) with CTS experience
Delivering First Class Clinical Packaging Solutions
CSM is a global company with five sites across the U.S. and Europe dedicated to clinical trial supplies. Our innovative solutions highlight our flexibility in managing our clients' clinical trials and allow us to efficiently and quickly deliver medicines to patients in need. Regardless of the size or complexity of the project, CSM will expertly manage the clinical supply chain.
CSM's only focus is clinical trial supplies, which means 100% of our infrastructure is dedicated to making sure our clients' investigational medical products are packaged, labeled, and shipped on time and with the highest regard for quality. CSM is designed to be agile, which for clients translates to confidence that CSM is ready to meet their clinical trial needs regardless of conditions.
We understand our work within the clinical trial process could not happen without our dedicated employees.
- To plan, coordinate and supervise packaging and labelling projects and shipping/distribution projects.
- To maintain the Clinical Supplies area in accordance with GMP/GCP and local guidelines.
- To collect all documents concerning packaging, labelling and shipping projects for QP release and to file and maintain them in the electronical warehouse system and electronic client files.
- Supervise the reconciliation of distributed and returned clinical trial materials (drug and non −drug−supplies) incl. arranging of destruction.
- Control of project budgets, monthly update of revenues and invoice control
- Coordinate projects effectively across the operational departments.
- Act as primary contact and final accountable person between the customer and CSM operational departments to ensure customer satisfaction.
- Ensure that CSM services are delivered on time, within budget and according to the agreed quality standards.
- Preparation of audits and/or inspections from clients / local authorities
- Follow up of CAPAs
- Take part in the overall improvements of internal processes and systems.
- Familiar with clinical trial processes.
- Knowledge of packaging & labelling or supply chain in clinical trials is desirable
- Excellent organizational and planning skills.
- Ability to work under time constraints without jeopardizing quality
- Fluent in German and English, French would be an additional benefit.
- Excellent verbal and written communication skills.
- GMP - GDP - GCP knowledge.
- Affinity to work with different electronic systems.
- Team worker and team spirit.
- Assertiveness and diplomacy.
- Customer oriented.
This position is based in Schwalbach a.Ts (Germany).
At CSM, we provide competitive compensation and a complete benefits package. If you have the desire to work hard and play your part in making a difference in the lives of patients participating in clinical trials, we want you to apply today by submitting your resume to:
CSM Clinical Supplies Management Europe GmbH
Am Kronberger Hang 3
65824 Schwalbach a.Ts.
Herrn Adam Belhanes
Misumi Europa GmbH
Samsung SDS Europe Ltd. German Branch