Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
Responsibilities
Oversee site interactions post activation through site closeout
Identify critical data and process risks
Review study scope, budget and protocol content
Escalate risks to project manager
Propose and implement risk mitigations
Requirements
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Clinical Research Associate responsible for monitoring investigator sites, ensuring compliance with ICH GCP and protocol, conducting remote or on-site visits, managing documentation, and facilitating communication between sites and the project team.
Responsibilities
Monitors investigator sites with a risk-based monitoring approach
Ensures data accuracy through SDR, SDV and CRF review
Documents observations in reports and letters
Escalates deficiencies and follows issues to resolution
Maintains regular contact with investigative sites
Requirements
Bachelor's degree in a life sciences related field
Clinical Research Associate – responsible for monitoring investigator sites, ensuring compliance with ICH-GCP, managing documentation, and coordinating with sponsors and investigational sites.
Responsibilities
Monitors investigator sites with a risk-based monitoring approach
Ensures data accuracy through SDR, SDV and CRF review
Assesses investigational product through physical inventory and records review
Documents observations in reports and letters
Escalates deficiencies and issues to clinical management
Requirements
Bachelor's degree in a life sciences related field
Lead and oversee GCP quality strategy and compliance across Denali’s clinical trial portfolio.
Compensation
Salary Range: $171,000.00 to $223,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience.
Responsibilities
Lead GCP quality strategy on assigned Study Execution Teams (SETs)
Partner with the Zurich Site Lead and cross-functional leaders to drive site-level quality maturity and operational excellence
Lead proactive quality risk assessments and drive risk mitigation strategies throughout study execution
Own risk-based monitoring and analysis of quality issues, delivering strategic guidance aligned with ICH-GCP and applicable global regulations
Lead Sponsor inspection strategy, inspection management, regulatory interactions, inspection response activities, and CAPA effectiveness
Considered as the primary sponsor point of contact for the investigative site. Advanced level of competency in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning.
Responsibilities
Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards
Align, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles
Support, guide, and mentor junior personnel on Site Management activities
Customize site engagement strategy for assigned study/ies
Gather local/site insights and utilize site engagement tools to report/track progress and measure impact
Requirements
Medical
Scientific
Pharmacy
Nursing
Nice to have: 2 years in independent clinical research monitoring of investigational drug or device trials
FSP Associate Manager Project DeliveryLifelancer · Remote, US