Manager, Clinical Monitoring

🕒 Agosto 5

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $132.000 - $165.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

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Crinetics Pharmaceuticals

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2015

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Crinetics Pharmaceuticals é uma empresa de biotecnologia que desenvolve terapias inovadoras para doenças endócrinas. A empresa está focada em atender necessidades médicas não atendidas, criando tratamentos para condições como acromegalia, síndrome carcinoide, síndrome de Cushing dependente de ACTH, hiperplasia adrenal congênita e outros distúrbios endócrinos. A Crinetics está comprometida em melhorar a qualidade de vida dos pacientes através de ciência de ponta e ensaios clínicos robustos. Seu pipeline inclui candidatos promissores como paltusotina, que foi aceita pelo Food and Drug Administration dos EUA para o tratamento de pacientes adultos com acromegalia. A empresa colabora com profissionais de saúde e partes interessadas para garantir que suas terapias abordem problemas reais de forma eficaz e agreguem valor para os investidores ao entrar em nichos de mercado com necessidades significativas.

Descrição

• Support global and regional clinical trial operations and Clinical Monitoring management • Supervise Clinical Research Associates and support development of monitoring processes, procedures, and tools/templates • Develop and implement risk-based in-house and regional monitoring strategies for assigned studies • Lead monitoring activities, including review of protocols, CRFs, completion guidelines, study manuals, and related documents • Author or review Clinical Monitoring Plans and ensure CRA compliance • Manage CRA monitoring visit schedules based on risk indicators and site metrics • Review and finalize regional CRA visit reports and follow up on outstanding trip reports and letters • Track action items, queries, CRA performance metrics, site status, compliance, trends, and monitoring metrics • Support implementation of site corrective actions • Support TMF setup, maintenance, quality review, and final reconciliation • Develop and manage monitoring oversight strategies for CRO and FSP partners • Manage monitoring oversight visits and review CRO CRA monitoring reports • Mentor and provide leadership and direction to CRA team members from study startup through closure • Provide management and oversight of Crinetics and FSP CRAs • Conduct monitoring assessment and FSP oversight visits and direct support, training, or performance management • Ensure adequate CRA resourcing and plan reassignments or additional resources • Conduct annual performance assessments, salary recommendations, and promotion justifications • Participate in interviewing, hiring, onboarding, and orientation processes • Conduct or arrange training on SOPs, WIs, ICH-GCP, local regulations, and role-specific topics • Resolve training gaps and oversee team administration, including expenses, travel approvals, and time-off requests • Escalate performance, resourcing, training, and study-related issues to senior leadership • Support responses to audits and inspections • Perform other duties as assigned • Travel up to 30% of the time may be required

🎯 Requisitos

• BS in biological sciences or related discipline • At least 7 years of experience working in the biotechnology/pharmaceutical industry • Minimum of 2 years in a supervisory role • Experience in endocrine disorders preferred • Critical thinking, root cause analysis, and problem-solving skills • Understanding and demonstrated application of Good Clinical Practices, ICH Guidelines, and regulatory requirements • Ability to comply with safety standards and respect privacy and confidentiality • In-depth cross-functional drug development experience • Prior regulatory inspection experience preferred • Excellent writing skills for clinical trial documents • Excellent interpersonal, oral/written communication, and presentation skills • Excellent negotiation skills and tactful approach • Demonstrated leadership and management skills • Ability to assess risks, analyze options, and manage outcomes • Knowledge of current clinical trial industry trends • Monitoring experience in startup, execution, and closeout activities preferred • Experience with risk-based monitoring processes strongly preferred • Previous experience as a Lead CRA, Trial Manager, or equivalent strongly preferred • Ability to sit at a desk for long periods and use a telephone and keyboard • Ability to walk and lift up to 25 lbs. as required

🏖️ Benefícios

• Discretionary annual target bonus • Stock options • ESPP • 401k match • Medical insurance • Dental insurance • Vision insurance • Basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown • Equal employment opportunities • Reasonable accommodations for individuals with disabilities