Clinical Operations Manager
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Clinical Operations Manager overseeing monitoring, risk-based processes, and trial deliverables for AbbVie, an innovative medicines company. Supporting immunology studies, site oversight, training, and clinical team coordination.
Responsibilities:
- Manage day-to-day monitoring activities on assigned studies to ensure deliverables are met
- Track and maintain project metrics and deliverable status
- Communicate and escalate issues, risks, and staffing needs to Program Leads, RSMs, and the Clinical Trial Team
- Answer study questions and provide guidance as Allergan standard study process experts
- Review Site Feasibility Questionnaires and Site Qualification Visit reports
- Maintain tracking reports for SIV, IMV, RMV, and COV
- Develop monitoring documents and toolkits, including Protocol Specific Monitoring Plans, amendments, report annotation, visit checklists, and toolkits
- Provide PSMP training and assist with GSMO orientation sessions
- Conduct teleconferences with RSMs to deliver training and information
- Attend team meetings and disseminate information
- Collaborate with CTT and GSMO PL on study-specific eCRFs, completion guidelines, protocol deviation specifications, and user acceptance testing
- Serve as a Risk Based Monitoring ambassador and ensure RBM implementation and adherence
- Maintain the monitoring portion of the study portal
- Maintain knowledge of ICH/GCP, regulatory requirements, Allergan SOPs, and therapeutic-area protocols and amendments
- Monitor or co-monitor/oversee assigned trial sites
- Mentor new LSMs and assist with LSM orientation training
- Contribute to process development, improvement, and documentation to drive consistency
- Train RSMs on trial specifics
Requirements:
- Allied Health Professions degree (PA, RN, RPh), relevant clinical experience, or four-year life science degree
- Minimum 5 years monitoring experience in a pharmaceutical or medical device company or clinical research organization
- More than 5 years of industry experience
- Prefer candidates that have functioned as a lead monitor or have equivalent experience
- Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, and Microsoft OneNote
- Excellent written and oral communication skills
- Planning, organizing, metrics tracking, controlling, directing, and promoting innovation
- Decision making, judgment, and problem solving
- People relationships, influencing others, motivating employees, team building, and developing people
- Initiative and accountability
- Assigning work, reviewing work, and planning others' work
- Maintaining and coordinating activities
- Ability to train RSMs on trial specifics
Benefits:
- Equal opportunity employer
- Operating with integrity, driving innovation, transforming lives and serving the community
Similar Jobs
Clinical Operations Manager
Clinical Operations Manager overseeing customer delivery, compliance, revenue targets, and people leadership for Syneos Health’s India-based clinical trial teams.
Clinical Program Manager
Clinical Program Manager leading telehealth, remote monitoring, and digital health implementation for UAMS’s rural Arkansas initiative. Coordinating clinical workflows, training, quality improvement, and partner collaboration.
Senior Clinical Project Manager
Senior Clinical Project Manager overseeing oncology Investigator Initiated Studies, Collaborative Research, and Expanded Access Programs. Coordinating clinical operations, budgets, regulatory compliance, and cross-functional stakeholders.
Clinical Operations Intern
Clinical Operations Intern supporting documentation, data, and reporting for a biotechnology company developing therapies for severe medical conditions. Fully remote role designed around a university schedule.
Clinical Project Manager
Clinical Project Manager overseeing pharmaceutical, biotechnology, and CRO research studies for Alira Health. Leading sponsors, clinical teams, compliance, budgets, and trial milestones.
Clinical Operations Manager
Clinical Operations Manager overseeing country budgets, submissions, compliance and site readiness in Madrid. Supporting ICON’s sponsor-dedicated clinical research operations and trial start-up.
Clinical Project Manager – Clinical Research, IT
Clinical Project Manager leading U.S. clinical research projects and digital trial technology for Alcedis, a contract research organization. Managing regulatory submissions, budgets, sites, and international teams.
Clinical Operations Strategy Lead
Clinical strategy lead shaping CenterWell’s senior-focused primary care strategy. Evaluating opportunities, building business cases, and aligning leaders across Humana’s healthcare services organization.
IT Program Manager – Clinical Applications, Strategic Initiatives, AI
Technical Program Manager developing Advocate Health’s Epic Factory AI Program and clinical application strategy. Leading complex healthcare technology initiatives, workflows, and change adoption.
VP, Clinical Operations – Transitions of Care
Clinical operations VP building Urrly’s post-discharge service line. Designing care pathways, scaling distributed clinicians, and improving outcomes for health-plan members.
Manager, Clinical Study Operations
Clinical Study Operations Manager leading teams and device-based clinical trials at Beacon Biosignals, a brain precision-medicine company. Overseeing study execution, compliance, KPIs, sponsors, and ClinOps initiatives.
Associate Director, Clinical Operations
Clinical operations leader overseeing oncology clinical trials, budgets, vendors, and cross-functional teams at Gilead. Driving development of therapies for serious diseases.
Clinical Operations Specialist
Clinical Operations Specialist managing regulatory intelligence, dashboards, and accreditation data. Supporting healthcare programs at Capella University and Strayer University.
Senior Consultant – Clinical Operations
Senior Consultant leading clinical and regulatory consulting engagements for Lumanity, a global healthcare strategy and evidence partner. Integrating analyses, managing clients and budgets, and shaping recommendations.
Manager, Clinical Operations
Clinical operations manager scaling Daymark Health’s value-based oncology care platform. Designing launch infrastructure, care workflows, and reliable execution across markets and teams.
Head of Technical Operations – Clinical Engineering
Head of Technical Operations deploying Cardiosense’s medical AI and wearable cardiac monitoring solutions. Leading hospital integrations, manufacturing operations, clinical studies, and usage analytics.
Vice President – Clinical Operations
Vice President leading clinical operations for Pyramid Healthcare’s behavioral healthcare programs. Driving compliant care, clinical strategy, performance improvement, and multi-program leadership.
Senior Manager, Clinical Quality Assurance
Clinical Quality Assurance Manager supporting GCP compliance, audits, CAPAs, and inspections. Helping Summit Therapeutics advance global oncology clinical studies and investigational therapies.
Country Clinical Quality Manager
Clinical Quality Manager overseeing quality, compliance, audits, and GCP processes for Merck’s US clinical trials. Coordinating QC, investigations, training, suppliers, and regulatory responses.
Senior Manager, Clinical Operations – Clinical Process Owner
Senior Manager owning Clinical Operations processes, SOPs, and governance at a global precision medicine research organization. Driving compliant, scalable process improvement across clinical research functions.