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Wir haben zum nächstmöglichen Zeitpunkt folgende Position zu besetzen:

Clinical Trial Leader (m/f)

Referenznummer 179-2018

Ihre Verantwortungsbereiche:

  • Leads Clinical Trial Team (CTT) in operationalizing protocol
  • Creates trial level timelines and ensures all trial deliverables are met with high quality on time and within budget
  • Ensures all trial related documents including operational plans and systems (e.g. clinical database, IRT and etc.) required for Ethics/Regulatory submissions and trial initiation are developed by the CTT and vendors within the specified timelines
  • Manages trial allocation and coordination/management of activities leading to selection and initiation of sites
  • Ensures trial-level and site-level readiness for first site initiation
    Plans, drives and facilitates investigator meetings or equivalent investigator training with CTT and vendors
  • Prepares, implements and manages vendors including their sub-contractors and ensures oversight of trial activities outsourced to the vendors in collaboration with CTT
  • Manages and coordinates Investigational Medicinal Products (IMP) and non-drug supplies across regions and countries and ensures final drug accountability
  • Manages overall trial conduct to trial close out in coordination with CTT and vendors 
    Collects, tracks, and communicates trial status for enrollment, timelines, data entry/queries, trial materials; provides updates to relevant internal/external boards
  • Manages trial budget including completion of grant plan specifications, obtains relevant internal board approvals, revises budget when applicable, and reconciles at trial close out
  • Collaborates with Clinical Program Leader to define the scope of responsibilities of operational and medical/clinical data review within the data management plan or equivalent to ensure ongoing quality data review
  • Provides operational support for clinical study report (e.g. appendices)
  • Ensures complete close out of all sites (vendor materials, budget)
  • Ensures inspection/audit readiness including trial master file documentation

Sie bringen idealerweise folgende Voraussetzungen mit:

  • Ideally min. 5 years operational experience in planning/executing/reporting clinical trials
  • Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical development process
  • Experience with health authority inspections (FDA and/or EMEA) preferred
  • Demonstrated ability to effectively manage trial budget
  • Strong leadership and project management skills
  • Excellent in negotiation and conflict resolution
  • Ability to influence without authority
  • Ability to lead a global cross-functional team (including external partner) in a matrix environment
  • Strong interpersonal skills
  • Ability to work under pressure
  • Resolve issues independently and understand when to escalate
  • Fluent English (oral and written)

Wir bieten Ihnen:
  • Kreatives Arbeiten in X-functional Teams
  • Offene und wertschätzende Unternehmenskultur
  • Multikulturelles Umfeld
  • Arbeiten in einem attraktiven, hochwertig ausgestatteten Gebäude mit Betriebsrestaurant
  • Kostenfreie Sportangebote und Sprachkurse

Über Ihr Interesse und auf Ihre aussage­kräftigen Unter­lagen freuen wir uns! Bitte be­wer­ben Sie sich direkt über unser Karriere­portal www.morphosys.de/karriere. Wir bieten Ihnen nicht nur aus­ge­zeichnete Ent­wicklungs­möglich­keiten, sondern unter­stützen Sie von Anfang an – auch bei Ihrem Umzug.
MorphoSys AG, Semmelweisstraße 7, 82152 Planegg