Senior PV Case Manager - Clinical Trial Compliance Lead
CSL
CSL is seeking an experienced Pharmacovigilance professional to act as a case management expert, ensuring regulatory compliance across multinational trials and safety data processing. The role involves managing safety reporting plans, overseeing vendor activities, and preparing for PV inspections within a GxP framework. You will maintain required PV documents, monitor KPIs, and contribute to process improvements and CAPA/SOP initiatives for timely regulatory reporting. #J-18808-Ljbffr CSL
- ...experienced Pharmacovigilance professional to act as a Case Management SME across clinical trials, ensuring compliance with global regulations and GxP guidelines. You... ...with external vendors, delivering study-specific PV training, supporting inspections, and driving CAPA...Senior
- Acts as Case Management subject matter expert in cross-functional... ...teams for assigned clinical trials. Manages case... ...clinical studies to ensure compliance with national and... ...preparation and conduct of PV and other GxP... ...for case evaluations. Leads or oversees ICSR reporting...SeniorLocal area
- Connections Health Solutions in King of Prussia, PA, is seeking a Lead Licensed Case Manager for nights (7pm-7:30am) with every-other-weekend shifts.... ...person-centered treatment plans, ensure documentation compliance, and mentor junior staff while upholding recovery-focused...SuggestedShift workNight shiftWeekend work
- ...Role Senior Director of Clinical Operations overseeing global Phase I-IV trials in a biopharma focused on metabolic liver disease... ...time, within budget, and in compliance with regulatory standards. Responsibilities... ...CRO/vendor oversight, risk management, and cross-functional...Senior
- ...commercialization. The Senior Director for clinical operations will... ...Leads Certara Clinical... ...Operations and Study Management activities. Leads... ...conducted in compliance with SOPs,... ...oversight of clinical trials. Provides... ...Reviews and critiques case report forms/...SeniorLocal area
$262.06k - $306.73k
...our shared purpose: leading the fight against MASH... ...Phase 3 outcomes trial is evaluating Rezdiffra... .... Role Overview The Senior Director, Clinical Operations provides... ...while maintaining compliance with global regulatory... ...leadership, line management, and mentorship to Clinical...SeniorMinimum wageFull timeLocal areaFlexible hours- ...consulting throughout all phases of drug development, ensuring compliance with regulatory requirements. The ideal candidate will have... ...experience. The role involves close collaboration with senior management, mentoring junior staff, and presenting findings at industry...Senior
- ACL Digital is seeking a Clinical Data Manager in the United States (King of Prussia, PA area) to lead the data management lifecycle for clinical trials. You will oversee start-up through database... ..., and maintain regulatory compliance across studies. The role involves...SeniorRemote job
- HNTB is seeking an environmental scientist to lead NEPA documentation for major transportation projects across PA/NJ/DE/MD... ...supervise and guide junior staff, coordinate with project managers, and ensure compliance with environmental regulations. The role involves client-...Senior
- Connections Health Solutions is seeking a Lead Licensed Case Manager for Night shifts in King of Prussia, PA. You will coordinate... ...units, ensuring timely documentation and regulatory compliance, while acting as a clinical resource for the team. The role emphasizes recovery...Night shift
$199k - $343.85k
...Function: Discovery & Pre-Clinical/Clinical Development... ...and cures. We lead where medicine is going... ...disciplines, including GCO, Data Management, Statistics, Regulatory... ..., in concert with senior clinical staff, credible... ...emerging from clinical trial results. May interact...SeniorFull timeContract workWork experience placementImmediate start$143.01k - $168.47k
...connected by our shared purpose: leading the fight against MASH.... ...ongoing Phase 3 outcomes trial is evaluating Rezdiffra for... ...time, in the right way.The Clinical Trial Manager is an experienced clinical... ...efficiency while ensuring compliance with ICH-GCP, applicable regulatory...Minimum wageFull timeWork at officeLocal areaFlexible hours- ...Opportunity:In collaboration with the Lead Counsel, Global Clinical Development, as the Associate Director, Senior Counsel, Clinical, you will... ..., that are not otherwise managed by CRO, procurement, or... ...are not limited to clinical trial research agreements, clinical...SeniorFull timePrivate practiceWork at office
- ...BARDS division of the R&D group, seeks a senior biostatistician to lead statistical activities for drug/... ...development. The role involves designing trials, leading teams, and coordinating... ...statistical analyses across regulatory and clinical units. Ideal candidates hold a PhD or...Senior
- Radial, Inc. in King of Prussia, PA, is seeking a Senior Manager of Payroll & Time and Attendance to oversee all payroll operations for North America, including ADP platforms, time tracking, and compliance across the US and Canada. This role partners with HR, Finance, and...Senior
- ...Health and Safety professional to serve as the primary resource for safety expertise in our Berwyn operations. You will manage local safety compliance, develop procedures, and share information to protect employees 24/7/365, including incident analysis and root cause...SeniorLocal area
- Merck is seeking an experienced Clinical Trials Operations Lead to drive planning and execution of one or more clinical trials within the Tulisokibart... ...feasibility assessment, country/site selection, data management deliverables, trial level plans and timelines, and...Senior
- Delmarva Power & Light Co. is seeking a primary Health and Safety resource to lead safety programs, ensure compliance with OSHA and DOT, and support operations 24/7. The role includes incident analysis, root-cause investigations, and building safety awareness across regions...Senior
- ...is seeking an experienced Associate Director, Senior Counsel, Clinical to provide practical, timely legal support to its... ...for clinical contracting queries and help manage high-risk, complex agreements like clinical trial and vendor contracts. This hybrid role requires...Senior
- West Pharmaceutical Services seeks a Senior Director, Global Logistics, Warehousing & Distribution to design... ...across regions and businesses. You will lead the global distribution network, balance regulatory compliance with cost efficiency, and drive OTIF and service...Senior
- Honeywell Aerospace in Lansdale, PA seeks a Sr CAD Designer to lead CAD design, develop standards, and guide CAD engineers on complex projects. You will review drawings for quality, ensure compliance, and collaborate across teams to drive innovation and process improvements...Senior
- ...Healthcare Financial/Actuarial Senior DirectorAs a Healthcare Financial/Actuarial Senior... ...Analytics (FAA) Community of Expertise. You will lead financial and actuarial engagements for a... ....The Role:Lead Client Engagements: Manage financial and actuarial deliverables for...SeniorContract workTemporary workLocal areaFlexible hours
- ...As a Healthcare Financial/Actuarial Senior Director, you will be a key member of the... ...Analytics (FAA) Community of Expertise. You will lead financial and actuarial engagements for a... ...Role: Lead Client Engagements: Manage financial and actuarial deliverables for...SeniorContract workTemporary workLocal areaVisa sponsorshipWork visaFlexible hours
$274.5k
...Power for Purpose This position is for a Senior Medical Director within the... ...position will be responsible for supporting clinical trial(s) and lead subteams in clinical development. The... ...Qualifications): Leadership or management experience Board certified/eligible in...SeniorPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$258.83k - $293.48k
...our shared purpose: leading the fight against... ...Phase 3 outcomes trial is evaluating Rezdiffra... ...the right way.The Senior Director of... ...leadership to support clinical trial applications... ..., along with managing the day-to-day regulatory... ...a scientific case to effectively communicate...SeniorMinimum wageFull timeWork at officeLocal areaFlexible hours3 days per week$88.6k - $246.6k
...programs, with a strong focus on clinical research, clinical... ...oversight of quality systems and compliance programs.Lead and coordinate QA... ...readiness programs, and quality management systems at a regional and/or... ..., ICH guidelines, clinical trial regulations, and pharmaceutical...Full timePart timeWork at officeImmediate startWorldwide- ...About the Job Case Manager - Homeless Services Lansdale, PA Full-Time Bonus... ...recovery plans. Partner with participants, clinical staff, and community stakeholders to... ...plans, and required documentation in compliance with organizational and regulatory standards...Permanent employmentFull timeLocal area
- ...Research is a full-service clinical research organization, providing... ...and reporting of clinical trial data for all phases of drug... ...upon request. Interacts with senior management of pharmaceutical and... ...biostatistics department. Ensures compliance with Good Clinical Practices...Contract workWork at officeWorldwide
$96.01k
...Job title: SR. Clinical Data Manager Location: King of Prussia, PA RATE OF PAY: Up to $96,013.00 per year Mode: All On-site... ...external data transfer agreements, ensuring external clinical trial data are aligned with company Standards and specifications to...SeniorFull time$1,000 - $2,000 per month
...Connections Health Solutions is a leading provider of immediate-access behavioral... ...Days What You'll Do The Lead Case Manager provides direct clinical case management services while serving... ...planning. Documentation & Compliance Maintain accurate, timely, and complete...Hourly payFull timeTemporary workPart timeImmediate startFlexible hoursShift workNight shiftWeekend work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior PV Case Manager - Clinical Trial Compliance Lead. Be the first to apply!
- director case management King of Prussia, PA
- case manager - criminal justice King of Prussia, PA
- foster care case manager King of Prussia, PA
- case manager supervisor King of Prussia, PA
- targeted case manager King of Prussia, PA
- developmental disabilities case manager King of Prussia, PA
- rehab case manager King of Prussia, PA
- case manager King of Prussia, PA
- health services director King of Prussia, PA
- senior director clinical development King of Prussia, PA

