Clinical Research Director - Rare Diseases SanofiClinical Research Director - Rare DiseasesMorristown, NJ$178,500–$257,833.33 / yearExperience / Skills: MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization. On Clinical Development, the CRD: Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes.
NewClinical Research Study Manager - Oncology VitaliefClinical Research Study Manager - OncologySomerset, NJFull timeBy combining deep subject matter expertise with the experience of senior research practitioners, we help organizations accelerate study activation, optimize operations, improve financial performance, and build scalable workforce solutions that reduce costs, increase efficiency, and advance clinical breakthroughs for patients. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.
Senior Clinical Scientist SanofiSenior Clinical ScientistMorristown, NJ$148.50–$214.50 / hourBut progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Contract, Clinical Trial Associate PTC Therapeutics IncContract, Clinical Trial AssociateNJ$35–$47 / hourMinimum level of education and years of relevant work experience: Bachelor's degree in a relevant life science or healthcare-related discipline and minimum 2 years of clinical research support experience in a pharmaceutical, biotechnology, or related environment or a recognized equivalent of education and experience. This involves supporting Clinical Trial Managers (CTMs) with activities related to: study start-up investigator site feasibility and selection essential document review related to investigator site initiation and investigational product release and patient enrollment.
NewClinical Pharmacist – Emergency Department - Per Diem Capital HealthClinical Pharmacist – Emergency Department - Per DiemPennington, New JerseyOccasional physical demands include: Climbing (e.g., stairs or ladders), Carry objects, Push/Pull, Twisting, Bending, Reaching forward, Reaching overhead, Squat/kneel/crawl, Wrist position deviation, Pinching/fine motor activities, Talk or Hear. Demonstrates teamwork within Pharmacy Department and participate in group approach to patient care by providing support to peers and other practice areas as needed in addition to daily assignments.
Associate Director, Clinical Operations Protagonist TherapeuticsAssociate Director, Clinical OperationsNewark, New JerseyThe Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. The base pay range for this position at commencement of employment is expected to be between $185K and $205K / year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
Clinical Research Associate Rutgers The State University of New JerseyClinical Research AssociateNewark, NJAligned with Rutgers University-New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and five centers and institutes that focus on cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research. Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption.
Clinical Research Director SanofiClinical Research DirectorMorristown, NJ$206,250–$343,750 / yearParticipates and contributes to regulatory and safety documents and discussions: Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
Manager Clinical Data and Reporting Standards - SDTM Programming Hybrid AbbVie IncManager Clinical Data and Reporting Standards - SDTM Programming HybridFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Senior Manager, Clinical Programming Genmab ASSenior Manager, Clinical ProgrammingPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Clinical Trial Liaison Manager Recordati SpAClinical Trial Liaison ManagerBridgewater, NJHighly desirable but not required: Experience supporting regulatory submissions, previous roles working as a CTLM, study coordinator, research nurse, or in Med Affairs Operations, formal Project Management training or certification, and working with rare diseases. The CTLM represents RRD in site relations, supports study teams with startup and recruitment, and manages in-field activities of the contracted CRO, focusing on the CRA team.
Clinical Research Nurse Coordinator Actalent IncClinical Research Nurse CoordinatorLivingston, NJ$55–$63 / hourThis role involves assisting investigators in the preparation and implementation of new clinical trials, screening and enrolling study participants, and providing protocol-related clinical management to participants while on study. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
NewManager, Companion Animals Global On-market Clinical Studies & Outcomes Research Zoetis IncManager, Companion Animals Global On-market Clinical Studies & Outcomes ResearchNJ$93,000–$148,000 / yearThe role will ensure alignment of research with the Global Pet Care Strategy and foster close collaboration with regional colleagues, Technical Services, Marketing, Veterinary Medical Research & Development (VMRD), Regulatory Affairs, Global Medical Portfolio Support (GMPS) and Global Portfolio Marketing (GPM). Proven track record designing and executing outcomes and real world evidence studies in companion animals (e.g., comparative effectiveness, PRO/HRQoL, adherence, utilization), including economic analyses and decision modeling.
Sr. Manager, Clinical Trial Operations Planning & Analytics Legend Biotech CorpSr. Manager, Clinical Trial Operations Planning & AnalyticsSomerset, NJ$127,313–$167,099 / yearHeadquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. The position partners closely with Clinical Operations leadership and cross-functional stakeholders to determine and assess assumptions, refine strategy, and translate data into actionable operational decisions across the study lifecycle.
NewClinical Manager Integrated Resources, IncClinical ManagerEast Hanover, New JerseyContractorSupport the development, management and tracking of trial budget working closely with the appropriate partners in OGD.• Participate in the organization and logistics of various oversight and Advisory boards; attend meetings.• QualificationsInvolvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities.
Clinical Research Coordinator- Warren, NJ (Temp to Perm) The IMA GroupClinical Research Coordinator- Warren, NJ (Temp to Perm)Warren, New JerseyOur Payer Services Division meets the evaluation and screening needs of Carriers, TPAs, Public Entities and Employers and includes behavioral health and physical medicine specialty services, working with a wide range of organizations within the workers' compensation, disability, liability, and auto markets. Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities.
NewClinical Data Manager ( multiple positions) Integrated Resources, IncClinical Data Manager ( multiple positions)Parsippany-Troy Hills, New JerseyContractorClinical Data ManagerNEURO/GENERAL MEDICINEThe Clinical Data Manager of Data Management at is a DM Generalist; will need to have a grasp on all aspects of DM from study start up, interpretation of study protocols, CRF design, UAT study conduct tasks, managing of off shore DMs and all processes related to DM lock. The Data Management group requires an operational Clinical Data Manager DM due to an increased number of new studies (15 or more) We are requesting a new hire (Contractor) in order to minimize the impact to the programs, study start-up and DM lock timelines.
Clinical Trial Manager in Princeton, New Jersey, United States of America | Development Operations at Genmab Government of DenmarkClinical Trial Manager in Princeton, New Jersey, United States of America | Development Operations at GenmabPrinceton, NJClinical Trial Manager in Princeton, New Jersey, United States of America | Development Operations at Genmab Skip to main content Skip to main content Healthcare Professionals Patients & Care Partners Partnerships Contact Working at Genmab Career Areas Application Process Locations Talent Community Job Search Corporate Sign in Close the popup Sign in to Phenom Careers Enjoy a personalized jobs search Sign in with Google Employee Login Sign in with Google Sign up Saved jobs (0) Healthcare Professionals Patients & Care Partners Partnerships Contact Saved jobs (0) Toggle navigation - - Recruitment Fraud Warning: Please note that Genmab never requests payment, banking details, or Social Security numbers during the recruitment process. Close Covid-19 banner Clinical Trial Manager Category Development Operations Job Id R16058 Hybrid This job available in 3 locations Princeton, New Jersey, United States of America Copenhagen, Capital, Denmark Utrecht, Netherlands Save Apply Now We are extra[not]ordinary*(ex· tra· not· or· di· nary |\ ik- str-not- r-d - ner- ) Adjective: A unique word for Genmab meaning to go way beyond what is usual; to be remarkable; proudly unique and authentic Back to search results Previous job Next job JOB DESCRIPTION At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases.
Clinical Research Associate - Part Time Saint Peter's Healthcare System IncClinical Research Associate - Part TimeNew Brunswick, NJMaintain oversight of designated research project study activities including performing the following functions: Subject recruitment, Consenting and Enrollment/Randomization, Perform study procedures/assessments in accordance with clinical trial guidelines, Complete Data Entry into Case Report Forms and Query Resolution, Process/Ship Specimens per trial requirements, Maintain Regulatory files including delegation logs, FDA form 1572, training logs and other trial documents in compliance with federal and local regulations, Process IRB amendments, annual renewals, closures, etc, Attend regular meetings with members of the project at partnering institutions and sponsors to report on study progress. Initiation / implementation of the observational or clinical research projects assigned including: Maintenance of Investigator and Research Staff CVs, Licensure and Training Records, Drafting and updating the Informed Consent Form with CIRB Boilerplate, Completion of Institutional Review Board (IRB) modifications with supporting documentation.
Senior Manager, Global Clinical Scientist - Psychiatry Bristol Myers SquibbSenior Manager, Global Clinical Scientist - PsychiatryPrinceton, NJ$173,390–$210,110 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Registered Nurse – Clinical Research - Warren, NJ The IMA GroupRegistered Nurse – Clinical Research - Warren, NJWarren, New Jersey$70,000–$85,000 / yearOur Payer Services Division meets the evaluation and screening needs of Carriers, TPAs, Public Entities and Employers and includes behavioral health and physical medicine specialty services, working with a wide range of organizations within the workers' compensation, disability, liability, and auto markets. Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities. .
Clinical Data Strategy, Manager Novartis AGClinical Data Strategy, ManagerEast Hanover, NJKey Responsibilities:Execute/support end-to-end data strategy activities at the trial and program level, including a) development of Data Strategy Plans to support early data planning and risk assessment, and b) downstream data oversight through subject matter guidance around data visualization and exploration to ensure high-quality outputs that support clinical trial teams and enable data-driven decision-making. #LI-HybridInternal Title: Senior Associate, Clinical Data StrategyLocation: London (The Westworks)Responsible for implementing high-quality, data strategy planning within clinical programs, supporting downstream clinical assessment identification and selection, data collection consistency and facilitating robust, rapid decision-making across the Translational Medicine portfolio.
Clinical Research Coordinator I SGS SAClinical Research Coordinator IUnion, NJ$22–$23 / hourPrepares, completes, organizes and maintains of all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study specific documents. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
NewClinical Trial Nurse - Per Diem Austin, TX IQVIAClinical Trial Nurse - Per Diem Austin, TXParsippany, TexasIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We are seeking experienced Registered Nurses (RNs) to support clinical trial patients through in-home visits in the Walnut Creek area.
Clinical Research Director - Immunology and Inflammation SanofiClinical Research Director - Immunology and InflammationMorristown, NJ$206,250–$343,750 / yearThe Clinical Research Director (CRD), Immunology and Inflammation Therapeutic Area, Solid Organ Transplant focus, is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy. In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees.
Clinical Research Director - Immunology And Inflammation SanofiClinical Research Director - Immunology And InflammationMorristown, NJ$206,250–$343,750 / yearThe Clinical Research Director (CRD), Immunology and Inflammation Therapeutic Area, Solid Organ Transplant focus, is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the clinical strategy. In addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees.
Clinical Research Director, I&I SanofiClinical Research Director, I&IMorristown, NJ$206,250–$343,750 / yearIn addition, the CRD is responsible for the development of abbreviated protocol and clinical protocol, participates to the review process for protocols, study reports, labeling, and contributes/supports interactions with regulatory agencies and ethics committees. The role requires a self-starting, creative, well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability to deliver on multiple operational tasks.
Payer STARS/Quality Clinical Consultant, Senior Manager PricewaterhouseCoopers LLPPayer STARS/Quality Clinical Consultant, Senior ManagerFlorham Park, NJ$124,000–$280,000 / yearAs a Payer STARS/Quality Clinical Consultant, Senior Manager, you will engage with clients in the health services sector, providing strategic guidance and operational consulting to enhance their clinical quality and performance metrics. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy .
Payer Stars/Quality Clinical Consultant, Senior Manager PwCPayer Stars/Quality Clinical Consultant, Senior ManagerFlorham Park, NJ$124,000–$280,000 / yearAs a Payer STARS/Quality Clinical Consultant, Senior Manager, you will engage with clients in the health services sector, providing strategic guidance and operational consulting to enhance their clinical quality and performance metrics. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy .
Prin. Scientist, Clinical Research Merck & Co IncPrin. Scientist, Clinical ResearchRahway, NJ$190,800–$300,300 / yearInterface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout research sites around the world. Contributing to the identification of novel targets by partnering with discovery research teams to bring a clinical perspective into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human disease in order to justify investment in clinical development programs.
Senior Principal Scientist, Clinical Research, Breast Cancer Merck & Co IncSenior Principal Scientist, Clinical Research, Breast CancerRahway, NJ$282,200–$444,200 / yearMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs; Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and. Assist the Senior/Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our Company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.
Associate Director, Global Clinical Data Standards Vocabulary Specialist Merck & Co IncAssociate Director, Global Clinical Data Standards Vocabulary SpecialistRahway, NJ$142,400–$224,100 / yearMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
Spanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - Washington IQVIASpanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - WashingtonParsippany, WashingtonRemoteThe potential base pay range for this role is The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Registered Dietician Clinical Trials Telehealth - Per Diem - Kentucky IQVIARegistered Dietician Clinical Trials Telehealth - Per Diem - KentuckyParsippany, KentuckyRemoteThe potential base pay range for this role is The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Spanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - Idaho IQVIASpanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - IdahoParsippany, IdahoRemoteThe potential base pay range for this role is The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Spanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - Missouri IQVIASpanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - MissouriParsippany, MissouriRemoteThe potential base pay range for this role is The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Spanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - North Carolina IQVIASpanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - North CarolinaParsippany, North CarolinaRemoteThe potential base pay range for this role is The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Registered Dietician Clinical Trials Telehealth - Per Diem - Tennessee IQVIARegistered Dietician Clinical Trials Telehealth - Per Diem - TennesseeParsippany, TennesseeRemoteThe potential base pay range for this role is The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Registered Dietician Clinical Trials Telehealth - Per Diem - New York IQVIARegistered Dietician Clinical Trials Telehealth - Per Diem - New YorkParsippany, New JerseyRemoteIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA, a global leader in advancing healthcare and clinical research, is seeking experienced Registered Dietitians to support patients participating in clinical trials.
Spanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - Nevada IQVIASpanish Bilingual Registered Dietician Clinical Trials Telehealth - Per Diem - NevadaParsippany, NevadaRemoteThe potential base pay range for this role is The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Senior Clinical Research Scientist Legend Biotech CorpSenior Clinical Research ScientistSomerset, NJ$127,313–$167,099 / yearHeadquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. Contribute to the planning and execution of external meetings and internal stakeholder meetings (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations.
Executive Director, Clinical Research (Medical Director) Eikon Therapeutics, Inc.Executive Director, Clinical Research (Medical Director)Jersey City, NJ$304,000–$367,500 / yearThis role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. Collaborate closely with Clinical Science and other relevant functions within Eikon and potential partners including discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, regulatory representatives, as well as personnel from Global Clinical Operations, and other support functions.
Sr. Clinical Trial Associate Allen SpoldenSr. Clinical Trial AssociateNew Brunswick, New JerseyFor assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including: Approval of study documentation, including essential document packets, study plans, informed consent forms, etc. Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
Clinical Trial Associate Allen SpoldenClinical Trial AssociateNew Brunswick, New JerseyFor assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including: Approval of study documentation, including essential document packets, study plans, informed consent forms, etc. Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
Senior Principal Scientist, Clinical Research, Immunology Merck & Co IncSenior Principal Scientist, Clinical Research, ImmunologyRahway, NJ$282,200–$444,200 / yearWork closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility. Required Skills: Clinical Development, Clinical Medicine, Clinical Research Management, Clinical Studies, Clinical Trial Development, Clinical Trials, Dermatology, Drug Development, Gastroenterology, Inflammatory Bowel Diseases, Pharmaceutical Industry, Regulatory Compliance, Rheumatology.
Clinical Outcome Assessment (COA) Lead SanofiClinical Outcome Assessment (COA) LeadMorristown, NJ$148,500–$214,500 / yearExample research activities for the COA team include the development of a disease conceptual model; the selection of COA instruments to measure specific concepts of interest; the psychometric assessment of the measurement properties of a COA instruments; the development and validation of new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs. Minimum 3 years of relevant experience in COA in Pharma/CRO/Consultancy: ideally proven track record from scientific publications in core COA disciplines such as COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation.
Director, Clinical Supply Chain IRT Summit Therapeutics plcDirector, Clinical Supply Chain IRTPrinceton, NJ$203,000–$253,000 / yearThe role will partner closely with Clinical Supply Chain, Clinical Operations, Quality, IT, external vendors, and study teams to deliver fit-for-purpose IRT solutions that support efficient study start-up, reliable execution, compliant change management, and scalable clinical supply operations. HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
NewClinical Trial Associate Integrated Resources, IncClinical Trial AssociateWoodcliff Lake, New JerseyContractorOur methods include applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective. Job DescriptionJob Title: Clinical Trials Disclosure Associate Duration: 1 year+ Location: Woodcliff Lake, NJ JOB DESCRIPTION: The Clinical Disclosure Associate will work across multiple disciplines within and outside Regulatory Affairs to drive departmental and project objectives.
NewClinical Imaging Specialist Integrated Resources, IncClinical Imaging SpecialistWoodcliff Lake, New JerseyContractorJob DescriptionJob SummaryContribute to, review and approve imaging core lab documents:Data Transfer SpecificationsCommunication PlansImaging Core Lab RFPs and proposalsImaging Core Lab forms and study-related documentsReview and design tumor assessment Case Report Forms in eCRFReview data derived from imaging aspects of protocols, collaborating with Clinical Operations, Biostatistics and Data ManagementReview tumor assessment sections of Patient Profiles from site CRF data and provide feedback to Data Management for site queriesAct as the Imaging representative on teleconferences with CROs and imaging core labsAssess, analyze and proactively develop corrective action plans when neededManage ongoing tumor assessment scan reconciliation between eCRF and Imaging Core Lab to ensure that all scans are received in a timely mannerDescription of Required Skill Set:Scientific background with understanding of clinical development and drug development process together with a broad understanding and experience of clinical operations or data management with clinical trials using medical imaging. RECIST 1.1, mRECIST for HCC, irRECIST)Ability to work semi-autonomously with strong organizational, prioritization and analytical skillsQualificationsQualificationsBachelor's degree required in associated scientific discipline, Imaging Technologist experience preferred; Master's degree strongly preferred3+ years of pharmaceutical experience, with 3 years of experience with clinical trials with imaging aspects desiredONCOLOGY REQUIREDClinical Trial Imaging experiencePHARMA or CRO (Pharma) Imaging on clinical trialsOncology RequiredRECIST experienceFamiliar with review of patient profiles to review tumor assessment dataAdditional InformationFeel free to forward my email to your friends/colleagues who might be available.
Associate Director, Oncology Clinical Biomarker Asset Lead, Translational Development Bristol Myers SquibbAssociate Director, Oncology Clinical Biomarker Asset Lead, Translational DevelopmentPrinceton, NJ$214,020–$259,344 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Key responsibilities of this role are to act as a lead scientist to implement and deliver on biomarker strategies for clinical programs, develop reports and publications on translational data generated to support asset development and contribute to regulatory submissions.