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

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

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Herzliche Grüße,

Stefan Blöchl

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