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8 jobs similar to Senior Manager/Associate Director Clinical Monitoring Strategy & Optimization

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US

  • Provide operational oversight and support for multiple clinical research sites within the network.
  • Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
  • Build and maintain strong working relationships with Sponsors, CROs, and external partners.

Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.

$130,000–$150,000/yr
US 4w PTO

  • Partner with Clinical Operations leadership to support clinical trial execution.
  • Lead site feasibility, selection, initiation, and greenlight activities for clinical trial sites.
  • Provide guidance and oversight to CRAs, including trip report review and training support.

Immatics is dedicated to making a significant difference in the lives of cancer patients. They are a global frontrunner in precision targeting of PRAME, found in over 50 cancers, with cutting-edge science and a strong clinical pipeline.

Australia

  • Manage and motivate a team of CRAs to achieve Precision for Medicine’s quality standards.
  • Support the career development of the organization’s Clinical Research Associate (CRA) workforce.
  • Strengthen the quality and productivity of operations within the group.

Precision for Medicine is a Clinical Research Organization with a uniquely integrated offering. They combine novel clinical trial designs, industry-leading operational and medical experts, and advanced biomarker and data analytics solutions.

Canada

  • Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
  • Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
  • Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.

Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.

US Unlimited PTO

  • Serves as the medical monitor for clinical trials and assists in resolving major issues that may affect their assigned studies.
  • Partners with the Clinical Scientist, Data Manager, Pharmacovigilance Scientist, and other members of the study team to conduct the clinical studies.
  • Provides expert opinion and review for creation of key study documents, including clinical study protocols, safety and medical monitoring plans, charters, and informed consent forms.

Cullinan Therapeutics is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for cancer and autoimmune diseases. They have a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, and are advancing its mission to deliver new standards of care for patients.

US

  • Lead end-to-end Clinical Data Management activities for assigned clinical studies.
  • Ensure clinical data are accurate, complete, consistent, and inspection-ready.
  • Drive proactive risk identification, issue escalation, and resolution across study teams and vendors.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease, guided by core values and focused on innovation.

US

  • Oversees all aspects of study site management to ensure patient safety and data quality.
  • Independently conducts all forms of site visits and prepares monitoring reports.
  • Communicates effectively with site personnel and Precision Project and Clinical Trial Management.

Precision Medicine Group is a company that works in clinical research. They are an equal opportunity employer that values diversity and inclusion.

$300,000–$375,000/yr
US

  • Provide strategic leadership for biometrics across all clinical development programs.
  • Define and implement an integrated biometrics strategy supporting clinical trial design and data quality.
  • Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team and a strong financial foundation, they represent an outstanding opportunity for ambitious, mission-driven professionals.