(Senior) Clinical Project Manager (m/f/d)

50667 Köln
20.02.2019

Daten dieser Anzeige

Job-ID: 009677954
(Senior) Clinical Project Manager (m/f/d)

via OPTARES GmbH & Co. KG

Germany

https://www.bewerbung2go.de/erstellen/apply/1BO/009677954

Lead on or more multi-functional Clinical Study Teams/ Joint Clincal Study Teams Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless and timely access to bioanalytical and/ or safety data for review meetings and so allowing prompt decision making Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence Work with CRO partners to define a study specific monitoring strategy. Review Monitoring Plans, and CRA generated reports (as appropriate) Provide input to aid in the development of the clinical database, and clinical operations focused review of the clinical database specifications during set-up, and support data cleaning and data evaluation meetings and Results Interpretation Meetings (RIMs) Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices Visit investigational sites and Phase I Units to build and maintain relationships as well as to understand opportunities and challenges to study conduct, including enrollment, when needed for assigned clinical studies

We are searching as soon as possible for our pharmaceutical client for a dedicated and highly motivated (Senior) Clinical Project Manager (m/f/d) Late Stage Standort: Großraum Köln Kennziffer: 25172 Your responsibilities Lead on or more multi-functional Clinical Study Teams/ Joint Clincal Study Teams Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless and timely access to bioanalytical and/ or safety data for review meetings and so allowing prompt decision making Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence Work with CRO partners to define a study specific monitoring strategy. Review Monitoring Plans, and CRA generated reports (as appropriate) Provide input to aid in the development of the clinical database, and clinical operations focused review of the clinical database specifications during set-up, and support data cleaning and data evaluation meetings and Results Interpretation Meetings (RIMs) Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices Visit investigational sites and Phase I Units to build and maintain relationships as well as to understand opportunities and challenges to study conduct, including enrollment, when needed for assigned clinical studies Your qualifications At least three years' relevant experience an project management skills Capability to manage in- house and/ or outsourced regional or global late phase studies Substancial experience in study management in different indications and proven ability to manage complex multinational studies or mutliple simultaneous studies from start to end Motivation, mentoring and integration of individuals on multi-functional international teams Scientific and technical knowledge GCP and regulatory environment Medical knowledge and research expertise Basic principles of data management and statistics Ability to handle detailed technical matters and team dynamics Reconciliation of conflicting priorities Delivery of scientific/medical presentations and training to both large and small audiences Good interpersonal skills Proficiency in the Microsoft office suite About us Seit 2003 vermittelt Optares Medical erfolgreich Fach- und Führungskräfte an Unternehmen der pharmazeutischen, biotechnologischen und medizin­technischen Industrie. Dabei profitieren Sie als Kandidat durch unsere langjährige Branchenexpertise und unser weit reichendes Netzwerk zu den jeweiligen Entscheidungsträgern. Wir ermöglichen Ihnen somit den Zugang zu pass­genauen Positionen inklusive echten Heraus­forderungen und entsprechenden Weiter­entwicklungs­möglich­keiten. Die professionelle, diskrete und transparente Betreuung unserer Kandidaten während des gesamten Bewerbungsprozesses steht dabei für uns im Mittelpunkt. Your application Ihre Ansprechpartnerin Frau Bettina Cöppicus Senior Personalberaterin Tel. +49 5272 3931505 bettina.coeppicus@optares.de   Optares GmbH & Co. KG Personalberatung und -vermittlung Heiligengeist Höfe 8 26121 Oldenburg www.optares.de Folgen Sie uns auf Folgen Sie uns auf Xing LinkedIn Twitter

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Forschung & Entwicklung

Medizinische Tätigkeiten/ Gesundheits-/ Sozialwesen

Chemie/ Pharma/ Biotechnologie

Bereichs-/ Abteilungs-/ Gruppenleitung

Projektleitung/ Stabstelle/ Spezialist

Vollzeit

50667 Köln