Clinical Monitoring Manager (Sponsor - homebased) (PR-32916025)

Ort: Bayern, Deutschland
Gehalt: €60000 - €80000 per annum + Vergütung aller Überstunden
Spezialisierungen: Life Sciences
Vertragsart: Arbeitnehmerüberlassung
Jetzt bewerben

Sie bringen mehrjährige Erfahungen als 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 Monitoring Manager (gn)

Your Responsibilities:

  • Plans and designs site management processes from study start-up to closure in collaboration with CRO and Clinical Team meeting the requirements of the protocol
  • Set-up of performance metrics to oversee and monitor the performance of CRO and site activities
  • Participates in trial risk assessment and management activities; recognizes potential challenges within the protocol and operational aspects of the trial
  • Serves as main sponsor contact to CRO site management team
  • Participates in the CRO selection process and approves key CRO site management staff
  • Maintains a strong knowledge of the protocol and study procedures to be able to answer operational questions from the CRO
  • Contributes to and reviews study plans and documents (e. g. Drug Handling Manual, trial-level Informed Consent Forms (ICFs))
  • Approves local ICF customizations prepared by CRO and oversees timely ICF implementation on site level
  • Reviews and approves CRO monitoring plan, monitoring visit report annotations and Investigator Site File templates prepared by CRO
  • Develops and implements the Sponsor Site Management Oversight Plan
  • Supports operational trial feasibility and approves sites recommended by CRO for trial participation
  • Ensures that all essential documents are in place for approval of site initiation and release of Investigational Medicinal Products (IMP) to the sites
  • Performs periodic review of protocol deviations, site issues and monitoring visit reports to identify trends, quality / compliance concerns or any other areas for improvement and initiates appropriate actions with CRO site management team
  • Performs Sponsor Onsite Oversight Visits (co-monitoring visits) with the CRO Site Monitor
  • Provides governance on site-specific TMFs maintained by the CRO
  • Communicates with CRO site management team on a regular basis to assure proper adherence to protocol, study plans, timelines and other trial related topics
  • Participates in internal audits and Health Authority inspections as required
  • Contributes to the development and operationalization of clinical trial strategies
  • Performs ongoing review of established processes, identifies gaps, and implements actions to drive operational excellence
  • Acts as the primary reviewer of the CRO Monitoring Plan and is responsible for SMOP
  • Ensures consistency in the implementation of SMOP and other sponsor oversight activities across all (including standard way of working e.g., documentation of oversight activities)
  • Oversees the overall trial status as well as quality and escalates any identified issues that potentially impact the trial deliverables/timelines, data integrity or patient safety
  • Responsible for vendor relationship management; addresses any conflicts, observations, or areas for improvement with the CRO and facilitates communication; involves Trial Monitoring Leader for consultation or further escalation as required and if timely resolution with CRO is not possible

Job Qualifications:

  • Bachelor's degree or equivalent qualification in life science / healthcare, Master's degree is preferred
  • Ideally more than five years pharmaceutical industry experience with three to five years strong experience in clinical research in a field monitor role or a role overseeing clinical trials
  • Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical trial process
  • Previous experience in overseeing site management activities on a global level preferred
  • Experience with health authority inspections (FDA and/or EMA) preferred
  • Strong Project Management and leadership skills
  • Strong interpersonal and communication skills

Location: Homeoffice

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

Dieser Geschäftszweig der SThree GmbH betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.

Jetzt bewerben