# Clinical Research Lead

**Company**: Syneos Health
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/DEU-Client/Clinical-Research-Lead---single-client---Germany_25112224?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_f0d9624c-72d

## 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

## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- clinical research
- German
- English
- communication skills
- problem-solving skills

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/DEU-Client/Clinical-Research-Lead---single-client---Germany_25112224?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)