Clinical Trial Manager - CTM

Clinical Trial Manager - CTM

Ryvu Therapeutics

Kraków, Poland

The goal of Junior/Mid Clinical Trial Manager is to support Global Study Leader with managing the clinical study, vendors, and clinical operations teams.

KEY RESPONSIBILITIES

• Facilitate cooperation with CRO, sites, 3rd party vendors, and Ryvu study team members to deliver the clinical studies;
• Support the Global Study Leader in developing study budgets;
• Guides in the development and/or review of the key study documents and reports, e.g. study plans, manuals, and guidelines;
• Support in protocol development, CRF design, and clinical study report writing;
• Leads the CRAs in conducting pre-study, initiation, monitoring, and closing visits to study sites performed;
• Provide overall support to the clinical team members in order to manage the investigator sites and study data;
• Guides CRAs to ensure compliance with the study protocol and applicable regulations, integrity of the source data, and completion of all applicable source documents;
• Support Global Study Leader in study team meetings can independently run some study team meetings;
• Responsible for ensuring clean study data in eCRF and investigational site/data issues resolved;
• In cooperation with the delegated team ensures the amount of investigational product and supplies at clinical sites is sufficient for study conduct;
• Support Global Study Leader to ensure successful clinical trial planning, execution, and delivery;
• Provide the Global Study Leader with reports, trackers, and summaries as required in the study;
• Other responsibilities related to the employee’s specialization & competencies delegated by Supervisor;
• Adherence to departmental and company-wide health and safety regulations, applicable work rules, Standard Operating Procedures (SOP), and Q&A policies.

YOUR BACKGROUND

• Master's degree in the life sciences, chemistry or health-related fields;
• Minimum 3-year experience in clinical research (pharma/biotech/CRO) in Lead-CRA/Clinical Trial Manager/Global Study leader (or equivalent) role in international studies;
• Knowledge and active use of Ms Office (Excel, Word, Powerpoint, Outlook);
• High level communication, collaboration and problem-solving skills;
• Fluent English (speaking, reading, writing, comprehension);
• Current GCP training (must have).

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