Overview
Job Summary (Primary function)
Clinical Research Lead (CRL) is responsible to provide operational delivery and strategic Country inputs for clinical studies in the territory assigned (Australia and New Zealand) (Territory) 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), Regional Clinical Operation (ReCO) in the Territory to ensure corporate/country goals for patient recruitment and completion of key R&D; deliverables are met.
Responsibilities
- Supports ADCO through the following actions:
- Oversees local CRO activities in the Territory, for CRO Outsourced Study, to ensure corporate and country objectives are reached and potential country issues properly followed-up.
- Collaborates with Global Clinical Study Teams and Global Monitoring Teams, for In-House Model Study conducted in the Territory to ensure key Country project milestones and high quality are delivered.
- Collaborates with Country Study Start-up Management (SSM) Specialist or Clinical Research Associates (CRAs) in the Territory to ensure consistency and accuracy of all core documents for local EC submission, as applicable, for In-House Model Study (i.e. submission pack, document customization, translations, quality check).
- Supports site feasibility process to:
- Acts as the central point of contact for feasibilities in the Territory, for both In-House Model and CRO Outsourced Studies when feasibilities are requested or deferred by Global Study Teams or Global SSM Teams.
- Conducts site feasibilities to collect key information on competitive clinical studies, marketed and non-marketed drugs, co-medications and regulatory concerns, Standard of care, etc. in the Territory.
- Builds up professional relationships with investigators and key opinion leaders/thought leaders in the Territory.
- Once trained, supports Global Monitoring Teams to conduct co-monitoring and CRA assessment visits in the Territory, when needed and requested.
- Supports ADCO to prepare internal initiatives, meetings and training (as required).
- Supports ADCO to implement local SOPs/WIs, quality/compliance review and initiatives to ensure inspection readiness in the Territory.
- Acts as a Site Relationship Partner for specific studies to build and retain relationships through the lifecycle of Incyte clinical studies, to ensure an effective clinical study implementation and completion.
- Acts in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies.
- Collaborates with Medical Affairs Teams as well as internal stakeholders in the Territory, when necessary, for Country level external stakeholder management in the Territory.
- Collaborates with Global Monitoring Teams, Global SSM Teams, Global Clinical Trial Managers (CTMs), Global Regulatory and others as work needs.
Qualifications
- Education
- Minimum Bachelor of Science degree or equivalent degree.
- Experience
- Minimum of 5 years clinical research experience as CRA or Lead CRA or Project Manager.
- Operational and direct managerial experience in the planning, executing and reporting of clinical studies.
- Have experience in appropriate therapeutic areas; Oncology, Hematology, Inflammatory Diseases (preferable).
- Experience in developing effective relationships with key investigators.
- Language Proficiency
- Have capabilities of business level languages: English.
- Others
- Proven ability to establish and maintain effective working relationships with team members or managers, internal and external stakeholders
- Good knowledge of GCP, clinical study design, statistics, regulatory processes, inspection readiness and drug development process.
- Proven ability to work in a matrix organization.
- Excellent organizational, problem-solving, and written/verbal communication/presentation skills.
- Effective organizational and time management skills.
- Goal oriented, self-starter with proven ability to work independently in accordance with stated timelines and quality.
- Proven flexibility and adaptability.
- Available for domestic and international travel.
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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