Clinical Operational Manager (gn) (PR-32916025)

Ort: München, Bayern, Deutschland
Gehalt: €60000 - €80000 per annum + Vergütung aller Überstunden
Spezialisierungen: Life Sciences
Vertragsart: Festanstellung
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Sie bringen mehrjährige Erfahungen als CRA oder Study Manager mit und suchen den Sprung zu einem innovativen Sponsor-Unternehmen? Dann ist folgende Position bestimmt sehr interessant für Sie: Wir suchen für einen unserer Kunden - ein Biotechnologieunternehmen in München - einen

Clinical Operational Manager (gn)

Your Responsibilities:

  • Organizes the Clinical Trial Team meetings including agenda preparation, actions tracking and follow-up
  • Ensures assigned operational trial deliverables and their associated project plans are met according to timelines, budget, operational procedures and quality standards
  • Oversees the interfaces between the trial vendors and the established processes/systems to ensure accurate data or information flow including data integration, data transfer and reconciliation of information at the agreed time intervals
  • Manages and coordinates Investigational Medicinal Products (IMP) and non-drug supplies across regions and countries in collaboration with Clinical Trial Supply Manager
  • Prepares trial outsourcing specifications with input from the CTT, and coordinate the vendor selection process including business process walkthrough together with the Purchasing Manager
  • Collects and tracks trial status such as enrollment and timelines to monitor the trial progress and to update the relevant internal/external boards (e.g., Global Program Team)
  • In collaboration with other CTT functions, set-up and maintains trial-related processes/ systems and their key performance indicators (e.g., regional Contract Research Organizations (CROs), central laboratories, interactive response technologies (IRT), Clinical Trial Management Systems (CTMS), data analytics tools, clinical supplies) with the vendors as per protocol requirements and internal standards
  • Manages and oversees vendor activities and interactions during the conduct of the trial to ensure adherence to the agreed contract, timelines and budget
  • Accesses and addresses vendor performance ongoing during the trial conduct and escalate (if required) to the CTT for further actions
  • Takes the role of a CTL as assigned in clinical trial and leads the cross-functional CTT to
    operationalize the protocol
  • Ensures inspection/audit readiness including TMF documentation and participates in internal audits and inspections as required
  • Contributes to process improvement or acts as Subject Matter Experts for training or SOPs

Job Qualifications:

  • Master's / Bachelor's degree or equivalent qualification in life science/healthcare
  • Ideally at least five years of clinical research experience
  • Previous involvement with clinical trial development, implementation or reporting activities preferred
  • Through knowledge of Good Clinical Practice and familiar with the end-to-end clinical trial process including the interfaces
  • Fluent English (oral and written)

Haben Sie Interesse an dieser Stelle? Dann freue ich mich auf Ihre Bewerbung!

Herzliche Grüße,

Stefan Blöchl

Pharmazie, Pharma, Medizin, Freelance, freiberuflich, befristet, Medical, Biologie, Onkologie, Orphan, drug, Master, Bachelor, GCP, GxP, Clinical, CRO, Studien, klinisch, TMF, Prüfplan, Prüfbogen, Monitor, CRA, CTA, Clinical Research Associate. Trial Master File; GCP, GxP, Clinical

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