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Director, Clinical Operations
1 week ago
Sun Pharma (Taro Pharma) Princeton, NJ, United StatesDirector, Clinical Operations/CPM · Sun Pharma Advanced Research Company, Limited · Summary · The Director, Clinical Operations/CPM is responsible for the development of a Clinical Operations Team in the United States. Work with Function Head in Resource planning and assignme ...
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Director, Clinical Operations
1 day ago
Sun Pharma (Taro Pharma) Princeton, United StatesJob Description · Director, Clinical Operations/CPM · Sun Pharma Advanced Research Company, Limited · Summary · The Director, Clinical Operations/CPM is responsible for the development of a Clinical Operations Team in the United States. Work with Function Head in Resource planni ...
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Associate Director, Clinical Operations
1 day ago
Sun Pharma (Taro Pharma) Princeton, United StatesJob Description · Associate Director, Clinical Operations · Sun Pharma Advanced Research Company Limited Princeton, New Jersey · Summary · The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clini ...
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ACADIA Pharmaceuticals Princeton, United StatesPlease note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. · The Sr. Director, Vendor Management, DEI & FSP Operations plays a strategic and operational leadership role in delivering cl ...
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CLevelCrossing Princeton, United StatesExecutive Director Clinical Development amp Quality Operations · Location · Princeton, NJ, United States · Posted on · Jul 13, 2020 · Apply for this job · your email: · upload resume: · Profile · At Bristol Myers Squibb, we are inspired by a single vision - transforming patien ...
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Director Clinical Operations
6 days ago
Johnson & Johnson New Brunswick, United StatesDePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medic ...
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Clinical Operations Manager
3 weeks ago
MSD Malaysia Trenton, United StatesClinical Operations Manager page is loaded · Clinical Operations Manager · Apply · remote type · Hybrid · locations · GRC - Attica - Alimos · time type · Full time · posted on · Posted Yesterday · job requisition id · R290772 · Job Description · Position overview: · ...
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Director of Clinical Operations
4 days ago
EVOLUTION RESEARCH GROUP Staten Island, United StatesJob Details · Job Location · LOC022 RBA Richmond Behavioral Associates - Staten Island, NY · Director of Clinical Operations · Title: Director Clinical Operations · Location: Staten Island, NY · About us: · ERG is a leading U.S. based, privately held, independent clinical resear ...
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Clinical Study Manager, Clinical Operations
2 days ago
Daiichi Sankyo, Inc. Basking Ridge, United StatesJoin a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class sci ...
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Associate Clinical Operations Manager
3 weeks ago
MSD Malaysia Trenton, United StatesAssociate Clinical Operations Manager page is loaded · Associate Clinical Operations Manager · Apply · remote type · Not Applicable · locations · ARG - Buenos Aires - Munro · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · R294361 · Job D ...
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Scientist, Clinical Supply Operations
2 weeks ago
Bristol Myers Squibb New Brunswick, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
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Manager, Clinical Supply Operations
9 hours ago
PSG Global Solutions Careers Basking Ridge, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Manager, Clinical Supply Operations, working in Pharmaceuticals and Medical Products industry in 211 Mt Airy Rd, Basking Ridge, New Jersey, 079 ...
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Manager, Clinical Supply Operations
1 week ago
PSG Global Solutions Careers Basking Ridge, United StatesApply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Manager, Clinical Supply Operations, working in Pharmaceuticals and Medical Products industry in 211 Mt Airy Rd, Basking Ridge, New Je ...
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Director of Clinical Operations
2 weeks ago
ModivCare Trenton, United StatesModivcare · Director of Clinical Operations · Remote , · New Jersey · Apply Now · Are you passionate about making a difference in people's lives? Do you enjoy working in a service-oriented industry? If so, this opportunity may be the right fit for you · Modivcare is looking ...
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Director, Clinical Operations
2 weeks ago
Legend Biotech Trenton, United StatesLegend Biotech is seeking · Director, 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 p ...
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Clinic Operations Lead
2 weeks ago
Blackbird Health Jenkintown, United StatesAt Blackbird Health, our commitment is to provide precision care with powerful outcomes for children, adolescents, and young adults struggling with social developmental and school-related challenges. We believe that our youth deserve the very best care, not only for their physica ...
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Clinical Operations Manager Lead
3 weeks ago
MSD Malaysia Trenton, United StatesClinical Operations Manager Lead page is loaded · Clinical Operations Manager Lead · Apply · remote type · Not Applicable · locations · MYS - Selangor - Petaling Jaya (Ascent Paradigm) · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · R289 ...
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Business Analyst
2 weeks ago
SSi People Princeton, United StatesJob Description: · The Business Analyst, GDO Excellence will be part of a team committed to improving performance and productivity of trial delivery through system and process change initiatives. In this role, the Business Analyst will demonstrate key skills including process de ...
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Clinical Study Manager, Clinical Operations
4 days ago
Daiichi Sankyo, Inc. Basking Ridge, United StatesJoin a Legacy of Innovation 110 Years and Counting · - Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class sc ...
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Clinical Project Manager
1 week ago
Sun Pharma (Taro Pharma) Princeton, NJ, United StatesResponsibilities Assigned: · Lead pivotal development program(s). · Team Mentoring, Motivating, Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs). · Oversee and manage all operational aspects of phase I ...
Director, Clinical Operations - Princeton, United States - Klein Hersh
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Description
The Director, Clinical Operations will provide operational and implementation expertise to the project teams under the guidance of the Chief Medical Officer.
He or she will lead activities associated with the evaluation, initiation, and management of clinical studies ensuring compliance, managing timelines, budgets and review of all clinical data.
The Director, Clinical Operations will serve as the primary contact for the contract research organizations (CROs), laboratory vendors and clinical sites involved in the clinical trials.
The Director will need to execute effectively as a member of a cross-functional team, leveraging colleagues from many functions in the company, influencing and leading all clinical operations outcomes.
The right candidate willhave the depth of clinical research experience and regulatory knowledge necessary to make independent operational decisions and be comfortable in executing daily operational tasks.
JOB RESPONSIBILITIES
Oversight of clinical trial site management in conjunction with selected CRO and CRA's, oversight of clinical trial site monitoring and source documentation verification
Development of in-house operations SOPs, guidelines and systems
Lead development and maintain departmental/clinical trial budget
Assist the Chief Medical Officer in protocol design and provide advice on logistical issues
Input/prepare patient informed consent document (ICDs)
Ensure timelines and milestones relating to the clinical trial are being met including but not limited to site activations, enrollment, first patient in, last patient last visit, and reviews for data safety monitoring boards and data monitoring committees.
Preparation and updates of Investigational Drug Brochures (IBs)Preparation and management of clinical trial site budgets
Preparation of regulatory documents including INDs, IND annual updates, briefing documents, CTAs, and regulatory meeting briefing documents as requested
Guide clinical trial report preparation and data interpretation
Preparation of Investigator Alert letters and SAE reports as required and ensure reporting timelines are met
JOB REQUIREMENTS
Bachelor's degree in a scientific discipline; advanced degree preferred.
8 or more years of drug development experience, at least 4 of which in clinical operations in a pharmaceutical or biotech company
4 or more years of oncology drug experience
2 or more years immunotherapy experience
Strong working knowledge of the drug development process, with experience in clinical studies from Phase 1 to Phase 3
In-depth knowledge of ICH/GCP guidelines and FDA regulations.
Ability to work independently
Excellent oral and written communication skills
Travel requirements – international, approximately 20-25%
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