Clinical Study Coordinator

hace 7 días

Madrid, España Mabxience A tiempo completo

Overview:
At MabXience, ensure the seamless execution and oversight of clinical trials under your responsibility, delegated to CROs. Guarantee that all trials are conducted within the established timelines and quality standards.

**Responsibilities**:

- **Manage the clinical trial plan**, communicate any timeline deviations to the Medical Director, and participate in creating contingency plans and corrective measures.
- ** Select and oversee CROs and external vendors**, ensuring all activities are executed according to plan (cost, quality, and time).
- ** Collaborate with study partners and the Medical Director** to identify centers and researchers, ensuring trial performance criteria are met.
- ** Review necessary documentation** to obtain approvals from CEICs and Health Authorities.
- ** Create and update the monitoring plan** for the study.
- ** Review and approve all trial materials and guidelines**.
- ** Supervise IMP control**, including distribution, handling, stock management, and destruction.
- ** Oversee blood sample control** for pharmacokinetic/pharmacodynamic studies, ensuring timely shipment for analysis and storage.
- ** Inform and update researchers** on all relevant aspects of the clinical trials.
- ** Ensure the quality of participating centers** in the monitored studies.
- ** Participate in forming and coordinating Independent Committees** (IDMC, IRC, etc.), maintaining documentation traceability.
- ** Prepare materials for initial visits** to supervised centers.
- ** Draft and coordinate protocol amendments**, ensuring new versions are edited as needed.
- ** Review trial documentation** (monitoring reports, teleconference minutes, etc.) to ensure alignment with plans.
- ** Maintain communication with potential partners**, providing monthly updates and organizing kick-off meetings.
- ** Create and maintain files for CROs and mAbxience centers**, organizing study file transfers and final quality control.
- ** Conduct co-selection, monitoring, and closing visits** as required, and perform monitoring tasks if assigned.
- ** Organize and participate in researcher meetings** for the clinical trial.
- ** Create and maintain a tracking system** for CRO activities, country-specific activities, recruitment, and vendor management.
- ** Participate in audits**.
- ** Ensure compliance** with company procedures, Good Clinical Practices, and applicable legislation for all clinical trials under your responsibility

Qualifications:

- ** Education**: Degree in Health Sciences; a Master’s degree is a plus.

**Languages**: Fluent in Spanish and English; additional languages are an asset.

**Experience**: Over 4 years in a similar role, managing international clinical trials.

**Specific Knowledge**: Must have knowledge of applicable laws in international clinical trials.

**Travel**: Willingness to travel.

**Personal Skills**:

- Strong organizational and prioritization skills
- Detail-oriented
- Proficient in database and literature searches
- Excellent interpersonal skills and effective in a team environment
- Clear and effective written and verbal communication skills
- Ability to work under pressure and meet tight deadlines
- Client-focused approach to work

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