Manager/Sr. Manager Global Monitoring US West Coast

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)

The Manager of Global Monitoring is responsible for the oversight and management of CRAs to ensure they are meeting expectations of core monitoring responsibilities for assigned clinical development programs in order to meet corporate objectives. Duties include, but are not limited to: (1) Ensuring monitoring activities are performed in compliance with ICH-GCP regulations and guidances; Declaration of Helsinki; Global Monitoring SOPs, processes and guidances; and all other applicable regulatory regulations and local laws; (2) Partnering with internal/external stakeholders to ensure CRAs deliver high quality study data and monitoring visit reports within requirement timelines; and (3) Collaborating with Country teams to manage and support monitoring resourcing, providing ongoing training, coaching, and feedback. If there is need and/or interest, the Manager may be assigned study sites to monitor, may co-monitor with other CRAs and may cover study sites for a short period of time, performing all duties noted above.

The Manager is a seasoned professional with wide-ranging CRA and CRA management experience and a thorough understanding of GCP and ICH principles. The experienced Manager identifies and resolves complex issues where an analysis of situations and data requires an in-depth evaluation of multiple factors. Exercising sound judgement in selecting methods and techniques and evaluating criteria for resolving issues, the Manager will establish strong, positive relationships with both internal and external partners. This individual contributes to the determination, development and/or implementation of efficient and effective approaches to managing clinical trials

Essential Functions of the Job (Key responsibilities)• Recruits, screens, interviews, hires, and supervises clinical monitors (Senior CRAs and CRAs).• Oversee daily operations of CRAs Reviews and approves CRA/Senior CRA leave requests, expense reports and other administration items, in countries where applicable.• Set and enforce project timelines with the assigned CRA team.• Schedule and manage 1:1 Meetings with assigned CRAs.• Reviews and approves CRA/Senior CRA leave requests, expense reports and other administration items, in countries where applicable.• Leads career talks with direct reports at designated time points throughout the year and supports staff's professional development, in countries where applicable.• Responsible for conducting CRA performance evaluations, setting goals and providing counsel when appropriate, in countries where applicable.• Motivates, guides and coaches CRA Team, identifies areas for new training or skill checks, and develops strategies to promote team member adherence to company procedures, standards and performance goals.• Conducts Monitoring Oversight Visits/Performance Assessment Visits to ensure CRAs are trained appropriately and to identify potential training or development needs.• Ensures CRAs assigned to team receive therapeutic and project-specific training.• Oversees the Corrective Actions/Preventative Actions (CAPAs) of assigned CRAs to ensure timely and adequate resolution.• Ensures that Global Monitoring SOPs, processes and guidances are aligned with ICH-GCP, Declaration of Helsinki, local and global requirements, remaining current with local laws, regulations and guidances.• Responsible for or assists ADCO (for EU sites) in resourcing / allocating CRAs to studies to ensure project needs are met.• Reviews CRA and Sr. CRA monitoring metrics to ensure they are meeting Key Performance Indicators (KPIs).

o Site management activities

o Assist in site selection.

o Regulatory document collection and review.

o Overall scheduling and management of all site visits. o Development of site/monitoring tools and training materials.• Assists in identifying trends in enrollment and data entry at sites and proactively interface with clinical monitoring team to identify solutions• Proposes and collaborates on department initiatives and strategies.• Develops and maintains collaborative relationships with internal and external partners.

Qualifications (Minimal acceptable level of education, work experience, and competency)• BA/BS, preferably in the Life Sciences or RN with 8 years of experience in Clinical Research, or equivalent, including at least 3-5 years in a role of primary clinical trial monitoring, execution and management• Strong organizational and communication skills• Extensive knowledge of Monitoring, including FDA and international regulations, GCPs, clinical trial design and documentation, and conduct of clinical trials• Demonstrated leadership and management skills• Experience in working in a global matrix organization• Excellent interpersonal, organizational, and problem-solving skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel• Goal oriented, self-starter with proven ability to work independently• Able to proactively identify issues and provide solutions for resolution• Excellent working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience• Ability to handle multiple tasks to meet deadlines in a dynamic environment• Must be able to travel (domestic or international) up to 2-3 days /month• Ex-US: Proficient in speaking and writing English and the country language when applicable• Possess a valid driving license

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.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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