**Summary**
The country Clinical Research Lead (CRL) responsibilities include operational delivery of strategic clinical studies assigned to the country, to support Incyte's pipeline, in accordance with ICH/GCP, Incyte 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.
**Responsibilities**
- 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, etc
- 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
**Requirements**:
- At least 5 years clinical research experience as CRA or Lead CRA or Project Manager
- Bachelor or higher University degree in life sciences, nursing or medical background 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 team work and cross-functional collaboration
- Ability to establish and maintain effective working relationships with co-workers, managers, internal and external stakeholders
- Effective oral, written and presentation skills, with the ability to communicate effectively with varied audiences
- Demonstrated professionalism and presentation of a positive image of the company
- Strong attitude to problem solving, effectively prioritize tasks and working independently
- Effective organizational and time management skills
- Proven flexibility and adaptability
- Available for domestic and international travel, including overnight stays up to approximately 20% of the working week
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.
Management reserves the right to change or modify such duties as required.
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