Technical Project Manager – Clinical Systems Canfield Scientific, Inc.Technical Project Manager – Clinical SystemsParsippany-Troy Hills, NJFull timeThe right candidate will possess strong organizational and problem-solving skills with attention to detail and excellent communication skills, who can translate between technical and non-technical stakeholders. This role sits at the intersection of information systems, software development, and operations, driving delivery of web-based clinical platforms used for medical imaging review and data workflows.
Clinical Study Manager, Clinical Operations Daiichi Sankyo, Inc.Clinical Study Manager, Clinical OperationsBasking Ridge, NJ$136,080–$204,120 / yearFull timeCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
NewClinical Study Manager, Global Clinical Operations Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical OperationsBasking Ridge, NJ$136,080–$204,120 / yearFull timeCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
Sr Clinical Study Assoc CO Daiichi Sankyo, Inc.Sr Clinical Study Assoc COBasking Ridge, NJ$100,960–$151,440 / yearFull timeKey focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Job Description. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
NewManager Data Management Daiichi Sankyo, Inc.Manager Data ManagementBasking Ridge, NJ$127,280–$190,920 / yearFull timeThe Manager, Data Management is accountable for end-to-end delivery of clinical data management services for assigned studies, collaborating with study teams, CROs, external vendors, and partners to ensure high quality deliverables are on time to support drug development processes and global submissions. Study Conduct: Ensures DM activities are executed according to timelines and quality expectations through collaboration with internal and external stakeholders (i.e., clinical data cleaning, external data transfers, SAE reconciliation, local lab data processing, medical coding, report specification review, study files management) .
NewExecutive Director, Oncology R&D, Global Clinical Lead Daiichi Sankyo, Inc.Executive Director, Oncology R&D, Global Clinical LeadBasking Ridge, NJ$329,025–$548,375 / yearFull timeClinical Monitoring Planning: Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL) Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines or contributes to department level surveillance activities across projects Study strategy: Interacts with leaders of each function to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level Study Outputs: For large-studies/programs, consults on responses to IRBs and HA; Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions External collaboration: Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KEEs for advice on complex development or safety issues; Maintains and leads external collaborations and advisory panels at department level People Management: Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; Monitor and manage direct report’s performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks; Participate in department’s planning for staff and cross-functional staffing plans for the Therapeutic Area. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.
Associate Director, Clinical Science Daiichi Sankyo, Inc.Associate Director, Clinical ScienceBasking Ridge, NJ$162,400–$243,600 / yearFull timeUnder supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred.
NewManager, EDC Database Programming Daiichi Sankyo, Inc.Manager, EDC Database ProgrammingBasking Ridge, NJ$127,280–$190,920 / yearFull timeThe Manager, EDC Database Programming is a member of the Biostatistics and Data Management team and serves as a subject matter expert for the oversight, guidance, and design of study build activities for all clinical studies Electronic Data Capture systems and other related technologies, Clinical Data Programming and Reporting. Manage and maintain administrative, operational deliverables, and timelines pertaining to study build activities, edit check programming, custom function development - including proactive review, testing, and supporting documentation to ensure high quality study builds for all studies.
Publication Manager I Daiichi SankyoPublication Manager IBasking Ridge, NJRemoteContractorGMA Publications Manager will help develop, deliver, and drive the execution of internal and external scientific communication strategy and related tactics including global publications (e.g., abstracts, posters, manuscripts) and scientific materials. Manage publication development activities in Datavision publication management software, including internal and external review and collection of authorship agreements, financial disclosures and author approvals.
Executive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
Director, Risk Based Quality Management (RBQM) Daiichi Sankyo, Inc.Director, Risk Based Quality Management (RBQM)Basking Ridge, NJ$201,840–$302,760 / yearFull timeOversee RBQM activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee Central Risk Managers to ensure proper implementation and execution of RBQM and inspection readiness. Interacts with and influences internal and external executive level and study level stakeholders on risk based quality management principles, process improvement, metrics design and application and other key drivers of enhanced quality.
NewContracts Specialist JouléContracts SpecialistPlainsboro Township, NJRemote$95,000–$95,000 / yearSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Review clinical trial protocols and develop investigator-specific budgets and site contracts for North American Clinical Operations.
Associate Director PV Quality, Americas Daiichi Sankyo, Inc.Associate Director PV Quality, AmericasBasking Ridge, NJ$153,600–$230,400 / yearFull timeProvide operational QA leadership for the respective CSPV teams, including Quality Oversight for the Quality Plan execution, review of key CSPV regulatory documents, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective CSPV functional areas. Interact with senior CSPV leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process.
Head of Global Biostatistics Daiichi Sankyo, Inc.Head of Global BiostatisticsBasking Ridge, NJ$271,500–$452,500 / yearFull timeProvides regular status updates on projects, metrics and KPIs to Head of BDM and BDM LT External Vendor Oversight: Provides oversight of and is accountable for the quality/performance and budget, resources and timelines across the department and ensures timely delivery of high-quality deliverables at reasonable cost. This role also serves as a key member of the BDM leadership team, contributing to BDM broader organizational strategy, cross-functional decision-making, and the advancement of BDM objectives beyond the Biostatistics function.
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timeAs a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval.
Clinical Trial Manager Impulse Dynamics Germany GmbHClinical Trial ManagerMarlton, NJ$95,000–$115,000 / yearFor Associate CTM: Minimum of 2 years of progressive experience in clinical operations, clinical trial management, or project management within the pharmaceutical, biotechnology, medical device, or contract research organization (CRO) industries. Lead study startup processes, including but not limited to conduct of the clinical trial Investigator meeting together with clinical and medical leadership, site selection, and finalization of site clinical trial site agreements and budgets.
NewClinical Trial Manager Impulse DynamicsClinical Trial ManagerNew JerseyFor Associate CTM: Minimum of 2 years of progressive experience in clinical operations, clinical trial management, or project management within the pharmaceutical, biotechnology, medical device, or contract research organization (CRO) industries. Lead study startup processes, including but not limited to conduct of the clinical trial Investigator meeting together with clinical and medical leadership, site selection, and finalization of site clinical trial site agreements and budgets.
NewClinical Trial Manager KardiganClinical Trial ManagerPrinceton, New JerseyThis position will be responsible for the oversight and management of Clinical Research Organizations (CROs) and vendors and will work cross-functionally on the trial operations’ strategy and related initiatives. Supports the Clinical Trial Lead (CTL) in the oversight and management of study CROs to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
Senior Clinical Trial Manager Rocket Pharmaceuticals IncSenior Clinical Trial ManagerCranbury, NJ$148,000–$197,000 / yearPartner cross-functionally with Clinical, Regulatory, Quality, Supply Chain, Biospecimen Operations, Legal, Procurement, and external vendors to support successful study execution and delivery of study milestones and clinical documents. Serve as the primary Clinical Operations lead and key point of contact for cross-functional study teams, investigators, CROs, vendors, and clinical sites.
Senior Clinical Trial Manager Rocket PharmaceuticalsSenior Clinical Trial ManagerCranbury, New Jersey$148,000–$197,000 / yearFull timePartner cross-functionally with Clinical, Regulatory, Quality, Supply Chain, Biospecimen Operations, Legal, Procurement, and external vendors to support successful study execution and delivery of study milestones and clinical documents. Serve as the primary Clinical Operations lead and key point of contact for cross-functional study teams, investigators, CROs, vendors, and clinical sites.
Clinical Trial Manager, Oncology, Asia Eikon Therapeutics IncClinical Trial Manager, Oncology, AsiaJersey City, NJ$130,000–$142,500 / yearCollaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines. In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international in-sourced clinical trials, delivering high quality study data, on time and on budget.
NewSr. Manager, Clinical Trial Lead KardiganSr. Manager, Clinical Trial LeadPrinceton, New JerseyMulti-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc. The CTL may lead trials at a global level (overseeing multi-regional execution) or at a regional level (driving operational delivery in assigned countries/territories), depending on business needs.
Project Manager, Clinical Trials Hackensack University Medical CenterProject Manager, Clinical TrialsNJThe Project Manager, Clinical Trials develops and implements comprehensive workflows and project/patient tracking procedures and tools to ensure ongoing clinical trial compliance across the assigned Research Program or Division. In addition, this role will be responsible for coordinating all aspects of clinical trial feasibility, start-up, conduct and close-out of all Clinical Trials being conducted within their assigned Research Program or Division.
Senior Clinical Trial Manager GenmabSenior Clinical Trial ManagerPrinceton, NJFull timeFor 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 Manager GenmabClinical Trial ManagerPrinceton, NJFull timeFor 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.
Senior Manager, Clinical Trial Materials Acadia Pharmaceuticals IncSenior Manager, Clinical Trial MaterialsPrinceton, NJ$124,200–$155,200 / yearIncludes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
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.
Project Manager - Clinical Trial & Medidata Roth Staffing CompaniesProject Manager - Clinical Trial & MedidataMahwah, New JerseyRemote$50–$55.69 / hourThis role focuses on leading cross-functional initiatives tied to clinical trial processes and Medidata implementation, ensuring project delivery from initiation through execution while maintaining timelines and budgets. The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive.
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.
Associate Director, Clinical Trial Lead (Princeton, NJ/ South San Francisco) KardiganAssociate Director, Clinical Trial Lead (Princeton, NJ/ South San Francisco)Princeton, New JerseyMulti-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
Clinical Trial Management Associate, Oncology EMEA/LATAM Eikon Therapeutics IncClinical Trial Management Associate, Oncology EMEA/LATAMJersey City, NJ$122,000–$133,000 / yearEikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. You are looking to grow beyond a CTA role and take on more direct responsibility for study deliverables, bringing with you valuable clinical research experience and a strong passion to contribute meaningfully to drug development through consistent operational excellence.
Contract - Clinical Trial Associate, Clinical Operations Shionogi Inc.Contract - Clinical Trial Associate, Clinical OperationsFlorham Park, New Jersey$40–$60 / hourSupport the Clinical Operations team with ongoing conduct of studies including specific allocated study management tasks as defined by the Clinical Trial Manager (CTM). Schedule Project related meetings, attend operational team meetings, write and/or review meeting minutes, distribute minutes and follow-up actions.
Clinical Trials Contracts Manager VitaliefClinical Trials Contracts ManagerNew Brunswick, NJRemoteFull timeIMPORTANT 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. #LI-DNP. KEY RESPONSIBILITIESIndependently review, interpret, negotiate, and process clinical trial agreements, nondisclosure agreements, and related contracts from legal, business, and technical perspectives, ensuring alignment with institutional policies and sponsor requirements.
Contract Clinical Trial Associate, Clinical Operations Shionogi & Co LtdContract Clinical Trial Associate, Clinical OperationsFlorham Park, NJ$40–$60 / hourSupport the Clinical Operations team with ongoing conduct of studies including specific allocated study management tasks as defined by the Clinical Trial Manager (CTM). Schedule Project related meetings, attend operational team meetings, write and/or review meeting minutes, distribute minutes and follow-up actions.
Director Communications Clinical Trials Merck & Co IncDirector Communications Clinical TrialsRahway, NJ$173,200–$272,600 / yearRequired Skills: Accountability, Collaborative Spirit, Content Creation, Data Analysis, Event Management, Internal Communications, Leadership, Management Process, Marketing Communications Planning, Media Publishing, Media Relations, Medical Communications, Online Content Development, Public Health Communications, Public Speaking, Reputation Management, Strategic Planning, Trade Media Relations. Summary: This role would support our Research and Development Division's BD&L Communications with clinical trial communications to help accelerate recruitment across priority clinical trials and to help increase representation of participants in clinical trials.
NewClinical Trial Associate II Allen SpoldenClinical Trial Associate IINew Brunswick, New JerseyWork with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model. The remote -based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.
NewSr. Clinical Trial Associate Allen SpoldenSr. Clinical Trial AssociateNew Brunswick, New JerseyWork with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model. The remote -based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.
NewClinical Trial Associate Allen SpoldenClinical Trial AssociateNew Brunswick, New JerseyWork with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model. The remote -based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.
Trial Vendor Senior Manager Novartis AGTrial Vendor Senior ManagerEast Hanover, NJJoin our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network. To collaborate with the Vendor Start-up Manager (VSM) for the VSM's category specific responsibilities and be responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study.
Manager, Trial Supplies Management Bristol Myers SquibbManager, Trial Supplies ManagementPrinceton, NJ$96,940–$117,472 / yearIssues Manufacturing and Packaging/Labeling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines and based on collaboration with Clinical Development team, Chemistry, Manufacturing & Controls (CMC) team and CSO Packaging and Labeling to ensure package design and clinical label for investigational product meet protocol and regulatory requirements. Actively participates in internal Trial Supply Management and Clinical Supply Chain meetings, Study Team meetings, Clinical Supply Matrix Team meetings and any other relevant meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation strategies.
Senior Manager, Clinical Monitoring Oversight Shionogi Inc.Senior Manager, Clinical Monitoring OversightFlorham Park, New Jersey$135,000–$165,000 / yearThe role encompasses supporting study risk assessments and defining RBQM study needs and strategies, which include determining the frequency and requirements for onsite versus remote monitoring activities, targeted SDV and SDR, and fostering constructive collaboration with cross-functional teams such as biometrics/data management, eTMF, and medical/safety monitoring. Review and collaborate to develop fit-for-purpose study plans that define risk-based monitoring strategies and the related tasks necessary to oversee critical study data and process (e.g., clinical monitoring plan, centralized monitoring plan, protocol deviation management plan, and integrated quality risk management plan).
Senior Manager, Clinical Monitoring Oversight Shionogi & Co LtdSenior Manager, Clinical Monitoring OversightFlorham Park, NJ$135,000–$165,000 / yearThe role encompasses supporting study risk assessments and defining RBQM study needs and strategies, which include determining the frequency and requirements for onsite versus remote monitoring activities, targeted SDV and SDR, and fostering constructive collaboration with cross-functional teams such as biometrics/data management, eTMF, and medical/safety monitoring. Review and collaborate to develop fit-for-purpose study plans that define risk-based monitoring strategies and the related tasks necessary to oversee critical study data and process (e.g., clinical monitoring plan, centralized monitoring plan, protocol deviation management plan, and integrated quality risk management plan).
Senior Clinical Data Manager Everest Clinical ResearchSenior Clinical Data ManagerBridgewater, New JerseyRemoteTo drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Managers for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.
Clinical Trial Physician Bristol-Myers Squibb CoClinical Trial PhysicianPrinceton, NJ$210,572–$255,164 / 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. In collaboration with the CDL, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets.
Clinical Study Manager, Global Clinical Operations - 30014765 Daiichi Sankyo Co LtdClinical Study Manager, Global Clinical Operations - 30014765Basking Ridge, NJ$133,600–$200,400 / yearCRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level. Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables.
Manager, Clinical Contracts & Finance - II* ACL DigitalManager, Clinical Contracts & Finance - II*Parsippany, NJManages the contract negotiation process across the entire life cycle including RFI vendor identification RFP vendor selection decision contracting negotiation performance monitoring change orders and ensures proper closeout of agreements to maximize contract value and achieve target savings. As part of our rapidly growing science-driven organization colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of Virology Inflammation and Oncology conditions.
Clinical Project Manager Becton Dickinson and CoClinical Project ManagerFranklin Lakes, NJ$110,200–$176,400 / yearClinical Project Manager serves as a study and project manager for studies of moderate to high complexity from protocol development through study conduct and study closeout in compliance with Good Clinical Practices, and all National and Local Regulations. Manages essential study documents, maintains the trial master file, supports approvals, and leads final study reporting and closeout activities for complex trials.
Senior Manager, Global Clinical Scientist - Psychiatry Bristol-Myers Squibb CoSenior Manager, Global Clinical Scientist - PsychiatryMadison, 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.