Clinical Research Lead
vor 5 Monaten
The country Clinical Research Lead (CRL) responsibilities include operational delivery of strategic clinical studies assigned to the country, to support client';s pipeline, in accordance with ICH/GCP, client SOPs, local operating guidelines and local requirements, as applicable.
CRL works locally, supporting Associate Director Clinical Operations (ADCO) / Director Clinical Operations (DCO), to ensure corporate/country goals for recruitment and completion of key R&D sponsor deliverables are met.
**Essential Functions**:
- Support ADCO / DCO to oversee local CRO activities, acting as Single Point of Contact for key and strategic outsourced clinical studies, to ensure corporate and country objectives are reached and potential country issues properly followed-up.
- Collaborate and liaise with Clinical Study Teams and Global Monitoring, for in-house clinical studies conducted within country/ies ensuring key project milestones and high quality are delivered.
- Partner with local Study Startup Specialist (SSS) or Clinical Research Associates (CRAs) to ensure consistency and accuracy of all core documents for local EC submission, as applicable, for in-house clinical studies (i.e. submission pack, document customization, translations, quality check).
- Support Feasibility process to act as the central point of contact for feasibilities in the country/ies, for both in-house and outsourced clinical studies when feasibilities are requested or deferred to country/ies by Global Teams
- Carry out top Level feasibilities, to collect key information on competitive clinical studies, marketed and non-marketed drugs, regulatory concerns, Standard of care
- Build up professional relationship with the investigators and Key Opinion Leaders.
- Liaise with Country, ADCO/DCA and EU CRA Manager for CRAs assignment
- Once trained, support the Global Monitoring team to conduct co-monitoring and CRA assessment visits, when needed and requested
- Supports ADCO / DCO to prepare internal initiatives, meetings and trainings (as required)
- Support the ADCO / DCO to implement local SOPs / WIs, quality/compliance review and initiatives, to ensure inspection readiness
- Act as a Site Relationship Partner for specific studies, to build and retain relationships through the lifecycle of the clinical study, to ensure an effective clinical study conduction and completion
- Act in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
- Collaborates with Medical Affairs Department, as well as all country internal stakeholders
- Collaborates and interact with QA, Global Monitoring, clinical Study Start-Up teams, Global Clinical Trial Managers (CTMs), Global Regulatory and other as work needs.
**Qualifications**:
- Bachelor';s Degree required
- At least 5 years clinical research experience as CRA or Lead CRA or Project Manager - will serve as a mentor to local CRAs
- Oncology Experience required. Dermatology experience also preferred.
- Demonstrated knowledge of clinical trial methodology and drug development process, related to monitoring clinical trials, GCP, SOP and country-specific regulatory requirements
- Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology
- Demonstrated attitude to teamwork and cross-functional collaboration
- Ability to establish and maintain effective working relationships with co-workers, managers, internal and external stakeholders
- Available for domestic and international travel, including overnight stays up to approximately 20% of the working week
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