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Clinical Operations Specialist
4 days ago
Rothman Orthopaedics Blue Bell, United StatesThe _Clinical Operations Specialist _provides a blend of clinical and administrative support to the office. Clinically, the COS will function as a Medical Assistant or Non-Surgical Clinical Assistant working alongside Physicians or Physician Assistants. In this capacity they will ...
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Vice President of Clinical Operations
1 week ago
i-Pharm Consulting Trenton, United StatesPosition Overview: As the Vice President of Clinical Operations, you will play a pivotal role in driving our client's clinical programs forward. You will be responsible for overseeing all aspects of clinical operations, from Phase I through Phase III trials. Your expertise in bui ...
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Vice President of Clinical Operations
5 days ago
i-Pharm Consulting Trenton, United StatesPosition Overview: · As the Vice President of Clinical Operations, you will play a pivotal role in driving our client's clinical programs forward. You will be responsible for overseeing all aspects of clinical operations, from Phase I through Phase III trials. Your expertise in ...
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Lpn, Home Care
1 week ago
SpiriTrust Lutheran Home Care & Hospice Chambersburg, United States**SpiriTrust Lutheran seeks a LPN** · **Up to a $5,000 Sign On Bonus** · **Education/Training**: Graduate of a school of nursing with current license(s) to practice as a professional nurse in the state(s) served by SpiriTrust Lutheran Home Care & Hospice; current CPR certificatio ...
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Behavioral Consultant
5 days ago
Momentum Services Chambersburg, United StatesMomentum Services, LLC was established in 2006 by experienced professionals in response to the ever-changing needs of demanding mental health community. Momentum Services' goal are to assist our consumers in developing the skills necessary for an improved lifestyle by providing t ...
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Social Worker
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Grane Home Health & Hospice Chambersburg, United StatesOur Company: · Grane Home Health & Hospice · Overview: · Our Hospice Social Workers are the heart of our organization who support patients by providing medical social work services and coordinating with the interdisciplinary team to ensure that both patients and their families ha ...
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Behavioral Health Technician
4 days ago
Momentum Services Chambersburg, United StatesMomentum Services, LLC was established in 2006 by experienced professionals in response to the ever-changing needs of demanding mental health community. Momentum Services' goal are to assist our consumers in developing the skills necessary for an improved lifestyle by providing t ...
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Revvity Trenton, United StatesAt Revvity, "impossible" is inspiration and "can't be done" is a call to action. Revvity provides health science solutions, technologies, expertise, and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what' ...
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Administrative Assistant
5 days ago
Gateway Foundation Inc Trenton, United StatesAre you looking to find personal and professional fulfillment, and align your career with your values? · At Gateway Foundation, our employees have an opportunity to make a difference every day by helping people with substance abuse issues gain control of their lives. · Gateway Fo ...
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Nexus Solutions Mercer, United StatesDual Study Program Bachelor of Business Administration - Health Management WS 2025 · Full-time · 97688 Bad Kissingen, Germany · No work experience required · Company Description: · We are a value-oriented psychosomatic and somatic clinic group based in Bad Kissingen. We operate 8 ...
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Strategic Purchaser
1 week ago
Eclipse Enterprises Trenton, United StatesStrategic Purchaser (m/f/d) · Full-time or part-time at Klinikum Darmstadt · Municipal maximum care provider: KLINIKUM DARMSTADT GmbH is the growing healthcare provider and emergency care provider of the highest level of care in southern Hesse. On the campus in the heart of the c ...
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Skyline Enterprises Trenton, United StatesTeaching Hospital / Major Care Hospital · Location: · North Rhine-Westphalia · Employer: · We are currently seeking a Senior Physician in Gynecology and Obstetrics (m/f/d) for a highly reputable client in North Rhine-Westphalia. · The teaching hospital / major care hospital has N ...
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Manager Clinical Operations FT
2 weeks ago
Capital Health Medical Group Pennington, United StatesOversees the operation of Capital Health's Administrative Nursing Coordinators and Clinical Staffing office to provide seamless 24/7 coverage of all nursing units at both the Regional Medical Center and Hopewell Medical Center. Assumes the responsibi Clinical, Operations, Manager ...
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Director of Clinical Operations
1 week ago
Prelude Fertility Philadelphia, United StatesWe are actively interviewing for a Director of Clinical Operations, who will be overseeing the details of our practice clinical operations for IVF treatment including patient care and customer service. This individual will have both IVF and leadership experience and will establis ...
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director, clinical operations
1 week ago
Legend Biotech Corp Somerset, NJ, United StatesCompany Information · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ...
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Supervisor Clinic Operations
1 week ago
Pennsylvania Medicine Philadelphia, United StatesPenn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, ...
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Supervisor Clinic Operations
6 days ago
Penn Medicine Philadelphia, United States**Description** · Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration w ...
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Clinical Operations Specialist
6 days ago
Collabera West Point, United StatesJob Description · Job DescriptionQualifications: · Title: Operations Planner-II · Education: High School/Associate degree/Bachelor's degree/Master's degree. · Work Experience Requirements: · • 3-5 years' experience in the pharmaceutical industry and/or clinical supply knowled ...
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Director of Clinical Operations
4 days ago
Assure Fertility Partners of Philadelphi Philadelphia, United StatesJob Description · Job DescriptionWe are actively interviewing for a Director of Clinical Operations, who will be overseeing the details of our practice clinical operations for IVF treatment including patient care and customer service. This individual will have both IVF and leader ...
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Director, Clinical Operations
1 week ago
InsideHigherEd Philadelphia, United States· Director, Clinical Operations · University Overview · The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universit ...
Director, Clinical Operations - Trenton, United States - Legend Biotech
Description
Legend Biotech is seekingDirector, Clinical Operations
as part of the
Clinical Operations
team based in
Somerset, NJ.
Role Overview
The Director, Clinical Operations is responsible for leading the planning and management and oversight of the Legend Biotech pipeline studies.
The Director, Clinical Operations will be responsible for all aspects of study conduct and CRO oversight and a point of contact for clinical study project management, communications and daily operations for the clinical INDs being held by Legend Biotech USA, Inc.
Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements is essential.
The position involves working closely with the Sr.Director of Clinical Research Operations and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, manufacture, supply chain, regulatory, project management, medical affairs, and quality.
This position requires the collaborating with project management to support the creation of study project plans, and end-to end-study timelines for execution of clinical trials from IND submission activities to first site activation.
In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, and represent the clinical trial operation function at internal and external meetings.
Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, cellular/gene industry landscape, clinical trials operations and FDA/ICH regulatory requirements is essential.
Key Responsibilities
Direct end-to-end clinical trial management activities domestically and globally: i.e. lead and take ownership in all aspects of study planning, start-up and oversight of study execution within clinical operations.
Lead clinical operation execution of complex protocols within a matrix environment (Project Management, Safety, outsourcing and vendor alliance management Data Management, Statistics, Clinical Supplies, Safety, etc.).
Collaborate with PM to create study project plans, end-to end-study timelines for execution of clinical trials from IND submission activities to first site activation
Collaborate with tech ops, procurement, legal, project management, finance, and other cross-functional team members to lead monthly process improvement meetings for optimal clinical operation performance.
Report on all aspects of the study progress at a granular level to operations management. Effective, consistent & regular tracking of project (s). Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Study Management Meetings).
Experience in working with and overseeing Contract Research Organizations (CROs) and other external vendors is required.
Oversee vendor selection process, negotiates contracts and budgets with sites and vendors and presents to the executive study team for approval.
Collaborate with Sr. Director of Operations and study leadership team to create preferred vendor list for clinical development. Lead vendor performance assessment for continuous process improvement
Management/oversight of external vendor deliverables reports and budgets. Study invoice payment tracking and projections.
Participates in all CRO study related calls and meeting, tracks actions, escalates issues and oversees all aspects of daily study operations.
Collaborates in the preparation and/or review of study-related documents (e.g., Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals).
Ensures audit-ready condition of clinical trial documentation including central clinical files. Prepare and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections.
Collaborates in the writing and review of study protocols, informed consents and amendments.
Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs.
Provides study-specific training and leadership to clinical research staff, including CRO, sites and other contract personnel.
Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.
Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
Excellent team player; willingness and ability to fill functional gaps in a small organization.
Working closely with the Sr.
Director of Clinical Research Operations and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, manufacture, supply chain, regulatory, project management, medical affairs, and quality.
Mentoring and management of Clinical Trial Managers (CTM).Requirements
Minimum degree requirements of a Bachelor's Degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred
Experience leading the planning and management of CAR-T studies preferred.
Demonstrated ability to multi-task and manage high performance demands
10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience. (15+ years preferred)
Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
CRO/Vendor oversight experience required
Project Management (CRO/biotech) experience a plus
Regulatory authority inspection experience a plus
Ability to travel as necessary (approximately 10 – 15 %)
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Director, Clinical Operations professionals in Trenton
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Kerry Nulman
Lead generation/business development consultant