Medical Director

hace 5 meses

Madrid, España Caidya A tiempo completo

Caidya is seeking an experienced Medical Director to oversee the medical and safety aspects of clinical trials. You'll ensure participant well-being and data integrity, collaborate with sponsors and cross-functional teams, and provide pivotal medical insights. Must have an MD, 5-10 years of research experience, strong communication skills, and be available for up to 20% travel. This role is integral to ensuring the medical credibility and success of our projects.
**Job Title**: Medical Director

**Job Location**: Madrid - Spain (Home-based, any Spanish location considered)

**Job Overview**:
Primary responsibilities include medical and safety oversight of clinical trials and corporate support for business opportunities. The Medical Director provides Medical Monitoring services to clinical trials with the aim of monitoring the safety and well-being of study participants, the integrity of the project data in accordance with the clinical trial protocol/clinical study protocol (or equivalent documents), standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable directives and regulatory requirements. Responsibilities include medical supervision of assigned projects from both a medical and scientific perspective. The Medical Director provides and/or oversees medical monitoring activities, including protocol development, development and/or review of project-specific Medical Monitoring Plan (MMP), review of other project-specific plans, responding to medically related questions, answering Medical questions arising at any stage of a clinical trial, and maintaining medical oversight for the conduct of a clinical trial. Reviews of medical data and/or safety information may be a regular part of the position. The Medical Director acts as the liaison between the Sponsor/Client who is responsible for medical decisions made in a project, the investigational sites and the project team. To perform functions, he/she may need to be available up to 24 hours / 7 days a week. The scope of responsibilities of the Medical Director depends on the contract with each Sponsor. The Medical Director also supports Business Development activities, as requested.

**Job Duties and Responsibilities**:
Job duties differ from project to project and are described in the contract, project-specific Plans (SMP; MMP), and/or other documents agreed with the Sponsor. Job duties also comprise any other tasks as defined by applicable Policies/SOPs/Work Procedures (WPs) and in general, include but are not limited to the following:

- Medical Monitoring:

- Provides Medical oversight of projects to ensure GCP/national and international regulatory requirements (as applicable), Policies/SOPs/WPs, and Sponsor directives are followed.
- Provides Medical consultation to Sponsors and project teams for protocol development and/or project activities, as indicated.
- Develops/updates the Medical Monitoring Plan (MMP), circulating it for approval within Caidya and externally (with Sponsor); maintaining the MMP up-to-date at all times during the project, escalating deviations from the MMP.
- Reviews project-specific plans, including the Safety Management Plan (SMP).
- Reviews and advises on project-related documents (e.g. study protocol, Informed Consent Form, clinical study report, etc.), as indicated.
- Develops and/or reviews project-related documents and reports, assesses and interprets project results.
- Reviews medical literature in the scope of preparation of project-related documents and provides input for the preparation of the respective documents.
- Reviews and assesses issues related to protocol compliance, including protocol deviations/violations, and development of the corrective and preventative actions.
- Trains CRAs and other team members on different topics, including medical and/or safety aspects of the project or therapeutic area/indication.
- May provide training to other medical monitors.
- Attends internal and external project meetings (e.g. Investigator meetings, Kick-off meetings, teleconferences, etc.).
- Attends data review meetings (interim analysis and final data analysis), as indicated.
- May participate in dose escalation meetings for early phase studies.
- May attend and provide review of documents for DSMB meetings.
- Reviews laboratory results and lab/ECG alerts, as required.
- Provides Medical review and assessment of SAEs, adverse events of special interest, SAE narratives, expedited and periodic safety reports, as requested.
- Prepares Analysis of Similar Events for expedited safety reports.
- May write Medical sections of periodic safety reports (e.g., risk-benefit assessments) and/or review safety data for trends.
- Provides Medical review of study data (presented e.g. in the format of listings, patient profiles, visual analytic templates, etc.), as per the MMP/Medical data review plan for clarifying and resolving data inconsistencies, query management, trend assessment, etc.
- May perform Med

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