Description
We are seeking a Clinical Research Lead to join our team in Germany. As a Clinical Research Lead, you will be highly integrated into our client's organization and will require extensive collaboration with a broad range of internal and external stakeholders.
Responsibilities:
- Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
- Oversees site interactions post activation through site closeout.
- May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
- Reviews the study scope of work, budget and protocol content and ensures the clinical project team is aware of the contractual obligations and parameters.
- Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
- Escalates to the project manager any risks to clinical trial management deliverables.
- Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
- Participates and presents in key meetings.
- Serves as an escalation point for communications with investigator site staff.
- Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
- Responsible for development and ongoing maintenance of clinical study tools and templates.
- Coordinates initial and ongoing training to the study team.
- Oversees resourcing allocations for CRAs and Central Monitors.
- Ensures quality of the clinical monitoring, central monitoring and site management deliverables.
- Reviews the project oversight dashboards and other clinical trial systems.
- Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan.
- Reviews the content and quality of site and central monitoring documentation.
- Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
- Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
- Oversees CRAs and Central Monitors assigned to the study.
- Provides feedback to line managers on staff performance.
Qualifications:
- Strong scientific background
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Experience overseeing trials in Germany
- Background as a CRA
- Excellent communication, presentation and interpersonal skills
- Fluency in German and proficient in English
- Ability to manage required travel