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Senior Global Clinical Trial Manager (m/f/d) #26548
Zum Unternehmen

Optares GmbH & Co. KG
Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort

Zur Position
Senior Global Clinical Trial Manager (m/f/d) #26548
 [Referenznr. 26548]
Aufgaben
Lead cross-functional teams and supervise vendors to ensure clinical trials are executed

Provide operational expertise to meet scientific objectives of the clinical studies

Partner closely with clinical development functions to design and write clinical trial protocols

Independently draft, review and implement study management plans and vendor oversight plans; ensure CROs and other vendors adhere to study plans

Provide direction and oversight of CROs and vendors to ensure delivery against scope of work; manage vendors by key performance indicators

Lead the identification and selection of study CROs and vendors, including negotiation of scope of work and budgets

Conduct study feasibility assessments; partnering with team and program lead on final country and site selection

Plan and execute investigator meetings and train vendors/ internal staff on study protocol and processes

Work with external partners to ensure that clinical data from a variety of sources is appropriately captured and of high quality

Participate in the ongoing and final review of study data and assessment of the impact of the data to the clinical development program

Proactively identify and mitigate study-specific risks; effectively communicate study status, risks, and changes that may impact quality, timelines, and cost to internal and external stakeholders

Manage study budget; identify and communicate variances

Participate in and lead department process improvement initiatives and system implementation

Review and provide input on cross functional SOPs, working practices and assist in the creation and improvement of department infrastructure as directed

Support preparation for Regulatory inspections
Anforderungen
Advanced scientific degree (MS/MSc/PhD) in life sciences or related discipline is prefered however can be replaced by a strong, proven experience in comparable positions or responsibilities

5+ years of experience in clinical development in the biotech, pharma or CRO industry

Experience in immunology or related therapeutic area

Proven ability to successfully plan, implement, and manage global clinical trials

Ability to manage cross functional clinical study teams to high performance

Proven ability to effectively manage and negotiate with CROs and clinical study vendors

Strategic thinking and project management skills

Agility and flexibility

Strong working knowledge of FDA, EMA & ICH/GCP regulations and guidelines

Highly effective verbal and written communication and presentation skills in English

Ability to travel
Wir bieten
Seit 2003 vermittelt Optares Medical erfolgreich Fach- und Führungskräfte an Unternehmen der pharmazeutischen, biotechnologischen und medizintechnischen Industrie. Dabei profitieren Sie als Kandidat (m/w/d) 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 (m/w/d) während des gesamten Bewerbungsprozesses steht dabei für uns im Mittelpunkt
Gewünschte Qualifikationen

Anstellung
Vollzeit
Funktionsbereich
Marketing/Werbung/Marktforschung
Marketing/Werbung/Marktforschung --Marketing/Service
Branche
Pharma/Biotechnologie
Einsatzort (Freitext)
München
Einsatzort (Region)
(Deutschland) Bayern
Einstellungsdatum
k.A.
Kontakt für Bewerber

Herr Tilman Grumbd
Geschäftsführer
Tel. +49 441 21879-34

eMail

mailto:tilman.grumbd@optares.de

 

 
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