Manager, Clinical Monitoring

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Crinetics Pharmaceuticals

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201 - 500 Mitarbeiter

Gegründet 2015

🏥 Gesundheitswesen

🧬 Biotechnologie

💊 Pharmazie

Healthcare • Biotechnology • Pharmaceuticals

Crinetics Pharmaceuticals ist ein Biotechnologieunternehmen, das innovative Therapien für endokrine Erkrankungen entwickelt. Das Unternehmen konzentriert sich darauf, ungedeckte medizinische Bedürfnisse zu adressieren, indem es Behandlungen für Zustände wie Akromegalie, Karzinoid-Syndrom, ACTH-abhängiges Cushing-Syndrom, kongenitale Nebennierenhyperplasie und andere endokrine Störungen schafft. Crinetics engagiert sich für die Verbesserung der Lebensqualität von Patienten durch modernste Wissenschaft und robuste klinische Studien. Ihre Pipeline umfasst vielversprechende Kandidaten wie Paltusotin, das von der US-amerikanischen Food and Drug Administration für die Behandlung von erwachsenen Patienten mit Akromegalie akzeptiert wurde. Das Unternehmen arbeitet mit Leistungserbringern im Gesundheitswesen und Stakeholdern zusammen, um sicherzustellen, dass ihre Therapien reale Probleme effektiv angehen und für Investoren Wert schaffen, indem sie Marktnischen mit signifikanten Bedürfnissen betreten.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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