Senior PV Case Manager - Clinical Trials
CSL Plasma Inc.
CSL Plasma Inc. is seeking a Senior Pharmacovigilance professional to serve as a case-management SME for ongoing clinical trials. You will ensure compliance with GxP and PV processes, manage safety reporting plans, and coordinate inspections and audits. Lead vendor oversight for PV activities, develop training for external vendors, and drive continuous improvements in pharmacovigilance procedures and reporting. Strong regulatory knowledge and data management expertise are essential. #J-18808-Ljbffr CSL Plasma Inc.
- ...experienced Pharmacovigilance professional to act as a case management expert, ensuring regulatory compliance across multinational trials and safety data processing. The role involves... ...vendor activities, and preparing for PV inspections within a GxP framework. You will maintain...Senior
- ...\n \n \n The Role: \n \n \n Acts as Case Management subject matter expert in cross-functional teams for assigned clinical trials. \n \n Manages case management activities... ...n Supports the preparation and conduct of PV and other GxP inspections and audits, as...SeniorLocal area
- ...The Role: Acts as Case Management subject matter expert in cross-functional teams for assigned clinical trials. Manages case management activities for assigned clinical studies... ...Supports the preparation and conduct of PV and other GxP inspections and audits, as required...SeniorFull timeLocal area
- CSL Behring is seeking a Case Management Subject Matter Expert to lead pharmacovigilance activities within cross-functional teams for assigned clinical trials. You will manage case management activities to ensure compliance with GxP guidelines and international regulations...Senior
- CSL is seeking a Senior Clinical Trial Case Manager to lead end-to-end case management for global biotechnology and pharmaceutical studies. In this role, you will oversee case processing, data review, and safety documentation, ensuring accuracy, patient safety, and adherence...Senior
$170k - $201k
The Senior Manager, Clinical Operations FSP Resource & Vendor Management sits within the Clinical Operations organization and is accountable for... ...Clinical Operations. Strong understanding of clinical trial execution and Clinical Operations functional models. Proven...SeniorRelocation package- CSL Behring is seeking a Pharmacovigilance Case Management specialist to act as SME in cross-functional clinical trials. You will manage case management activities to ensure PV compliance with GxP guidelines and national and international regulations, and you will oversee...Senior
$260k - $318k
...to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment... ...the right time, in the right way.The Senior Director, Clinical Scientist, will support the... ...Collaborate with clinical operations, data management, biostatistics, and medical writing to...SeniorMinimum wageFull timeLocal areaFlexible hours- ...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 clinical... ...but are not limited to clinical trial research agreements, clinical vendor...SeniorFull timePrivate practiceWork at office
$262.06k - $306.73k
...to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment... ...right time, in the right way. The Senior Director, Clinical Operations provides strategic and... ...provides organizational leadership, line management, and mentorship to Clinical...SeniorMinimum wageFull timeLocal areaFlexible hours- ...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
$274.5k
...Power for Purpose This position is for a Senior Medical Director within the Hematology... ...will be responsible for supporting clinical trial(s) and lead subteams in clinical development... ...Qualifications): Leadership or management experience Board certified/eligible in...SeniorPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week- ...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 clinical... ...but are not limited to clinical trial research agreements, clinical vendor...SeniorPrivate practiceWork at office
$199k - $343.85k
...Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub... ...disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC... ...develops, in concert with senior clinical staff, credible relationships... ...emerging from clinical trial results.May interact with...SeniorFull timeContract workWork experience placementImmediate start- CSL Behring in the United States seeks a Senior Manager, Clinical Operations FSP Resource & Vendor Management to lead end‑to‑end FSP resourcing across Clinical Operations, ensuring right capacity and capabilities to support portfolio delivery. You will partner with Global...Senior
$274.5k
...Job SummaryThis position is for a Clinical Development Senior Medical Director within the atirmociclib program. This individual contributor will be responsible for supporting clinical trial(s) and lead sub teams in clinical development. The successful candidate should...SeniorPermanent employmentFull timeH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week- ...Senior Clinical Data Manager The Senior Clinical Data Manager plays a pivotal role within Ocugen's clinical... ...to critical aspects of clinical trial data handling, including database design... ...and study-specific electronic Case Report Forms (eCRFs). Partner with...SeniorWork at officeRemote work
$70 - $85 per hour
...Job Description Job Description Job Title: Senior Clinical Study Manager Job Description The Clinical Study Manager oversees end-to-end clinical trial activities across phases 1 through 4, ensuring high-quality execution, regulatory compliance, and alignment...SeniorContract workTemporary work1 day per week$285k - $315k
...Job Title Senior Director, Clinical Development Requisition JR000015848 Senior Director,... ...will be responsible for oversight and management of the clinical development execution... ...etc. Ensure CD contributions to trial-related documents such as the IBs, ICF...SeniorWork at officeFlexible hours$117k - $184.2k
...is responsible for providing end-to-end COA systems project management support including, but not limited to: Gathering study-specific... ...for problem resolution between COA vendors and our Company's Clinical Trial Team. May participate in training and education for...SeniorFor contractorsWork experience placementLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...Senior Medical Director, Oncology Clinical Development - GU For candidates seeking to be located at our Stevenage... ...will also have a leading role in managing effective relationships with Key... ...developing and executing oncology clinical trials in support of the successful...SeniorWorldwideRelocation
$284.63k
Senior Medical Director, Clinical Development, Neurodegeneration GSK is seeking a highly skilled Senior Medical Director, Clinical Development... ...indication(s) and provide strategic oversight and management of clinical trials. Identify and highlight transformational...SeniorWork at officeLocal area2 days per week$232k - $401.35k
...Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub... ...& Johnson (J&J) is seeking a Senior Director, Clinical Lead - Neuropsychiatry... ...plans (including life-cycle management, geographic expansion, and... ...for the design of clinical trials and for the content of...SeniorFull timeLocal areaImmediate start$97k - $117k
...ongoing Phase 3 outcomes trial is evaluating... ...Director, Postmarketing PV, the Senior PV Associate II is responsible... ...review of Individual Case Safety Reports [ICSRs]... ...discipline. Clinical experience (e.g. RN, BSN... ...Pharmaceuticals’ Hiring Managers, seeking to engage with...SeniorMinimum wageFull timeLocal areaFlexible hours- ...service plan. Responsibilities include service planning, providing case management, and coordination of services with other agency providers to... ..., Psychology or related fieldOne or more years of direct clinical experience working with children, youth and familiesManage a...Hourly payTemporary workMonday to FridayAfternoon shift
$213k - $260k
...F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment... ...Reporting to the Vice President, Clinical Safety & Aggregate Reporting, the... ...in designing safety and PV processes highly desirableExperience in managing external teamsExperience leading...Minimum wageFull timeLocal areaFlexible hours- ...Transplant and Immunology) based in King of Prussia, PA or Waltham, MA in a hybrid onsite three days a week role, reporting to the Senior Director, Medical Affairs, Transplant & Immunology. You will develop medical strategy for inline products in Transplant & Immunology...Senior3 days per week
$143.01k - $168.47k
...to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated... ...have the right talent, at the right time, in the right way.The Clinical Trial Manager is an experienced clinical operations professional responsible...Minimum wageFull timeWork at officeLocal areaFlexible hours- ...candidate will have a Ph.D. in Biostatistics or an MS with considerable experience. The role involves close collaboration with senior management, mentoring junior staff, and presenting findings at industry meetings. Strong knowledge in FDA/ICH regulations and statistical...Senior
- ...lead and the primary point of contact for clinical study teams and external partners, (e.g.... ...data vendors and CROs) for multiple trials within a given TA. • Lead all aspects... ...within the program • Collaborate with data management peers and other cross functional...SeniorLocal area
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