Daiichi Sankyo, Inc.Clinical Study Manager, Clinical Operations Daiichi Sankyo, Inc.Clinical Study Manager, Clinical OperationsBasking Ridge, NJ$136,080ā$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 Sankyoās 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.
Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical Operations - 30014765 Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical Operations - 30014765Basking Ridge, NJ$133,600ā$200,400 / 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 Sankyoās 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.
Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical Operations Daiichi Sankyo, Inc.Clinical Study Manager, Global Clinical OperationsBasking Ridge, NJ$133,600ā$200,400 / 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 Sankyoās 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.
Daiichi Sankyo, Inc.Senior Manager, Clinical Database Applications and Reporting (m/f/d) Daiichi Sankyo, Inc.Senior Manager, Clinical Database Applications and Reporting (m/f/d)Basking Ridge, NJThe Associate Director, Clinical Database Applications and Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert responsible for setting the overall programming strategy including the oversight, guidance, implementation, and management of clinical database applications and reporting. Work Experience: Minimum of 7 years of global clinical trial experience in the device/pharmaceutical/CRO industry with expertise in clinical database programming, methods, and techniques supporting Clinical Data Management systems and services required.
Daiichi Sankyo, Inc.NewManager, Clinical Adjudication Operations Daiichi Sankyo, Inc.Manager, Clinical Adjudication OperationsBasking Ridge, NJ$127,280ā$190,920 / yearFull timeBecome a Subject Matter Expert (SME) with the process currently in use; be able to describe to study teams and other key departments how their study will interact with the adjudication vendor; Describe the expectation and importance of adjudication between the vendor to the CRO; Become an active āextended team memberā to multiple studies at the same time; Being extremely organized to discuss with studies at different timepoints. Support analysis of study site ILD adjudication metrics reports to identify potential areas of concern, trends, missing eDC pages, issues with image uploading; bring to the attention of the Study Team / CRO; offer solutions.
AramarkNewClinical Nutrition Manager AramarkClinical Nutrition ManagerNew Brunswick, NJ$100,000ā$125,000Develops, implements and documents in-service education programs for Registered Dietitians, Dietetic Interns and other nutrition personnel, including hourly dietary staff, to provide continuing education and training. Recognizes and adopts activities appropriate to the specific needs of the patient population and demonstrates knowledge of specific issues directly related to age of patient population.
Company ConfidentialManager, Scientific Affairs Company ConfidentialManager, Scientific AffairsParsippany, NJ$100,000ā$130,000 / yearFull timeDirectly and effectively partner and collaborate with DSA and DSI Supply Chain, Field Support, Training, Marketing, Quality and Legal to strengthen relationships and mutual trust. Develop, with Director of Market Access, key metrics for staff to ensure project timeliness and manage staff adherence to timelines.
JobotNewVice President Clinical Development Ophthalmology JobotVice President Clinical Development OphthalmologyNew York, NY$350,000ā$400,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. 4. Collaborate with cross-functional teams including regulatory affairs, pharmacovigilance, and medical affairs to ensure a holistic approach to product development.
Daiichi Sankyo, Inc.Sr Clinical Study Assoc CO Daiichi Sankyo, Inc.Sr Clinical Study Assoc COBasking Ridge, NJ$100,960ā$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.
Daiichi Sankyo, Inc.Manager, Statistical Programming (m/f)d) Daiichi Sankyo, Inc.Manager, Statistical Programming (m/f)d)Basking Ridge, NJDevelop and validate datasets and Tables, Listings, and Figures (TLFs) to ensure high-quality deliverables for pivotal studies, as well as Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) for oncology regulatory submissions. This role ensures the quality, consistency, and timeliness of deliverables supporting oncology regulatory submissions by guiding programming strategies, reviewing key outputs, and driving issue resolution.
VNS HealthClinical Case Manager, Care Management VNS HealthClinical Case Manager, Care ManagementNew York, NY$93,400ā$116,800Weāre one of the largest nonprofit home- and community-based health care organizations in the country, and today, more than 11,500 team members work together to make a difference in the lives of more than 99,000 patients and members on any given day. Anticipate and prevent patient incidents by addressing potential care or service-related issues communicated by Clinical Case Managers (CCMs), supervisors, HHAs, RNFS, patients, and caregivers.
VNS HealthClinical Field Manager ā Home Care Case Management VNS HealthClinical Field Manager ā Home Care Case ManagementNew York, NY$93,400ā$116,800Weāre one of the largest nonprofit home- and community-based health care organizations in the country, and today, more than 11,500 team members work together to make a difference in the lives of more than 99,000 patients and members on any given day. Anticipate and prevent patient incidents by addressing potential care or service-related issues communicated by Clinical Case Managers (CCMs), supervisors, HHAs, RNFS, patients, and caregivers.
Daiichi Sankyo, Inc.Associate Director, Clinical Database Applications and Reporting Daiichi Sankyo, Inc.Associate Director, Clinical Database Applications and ReportingBasking Ridge, NJ$153,600ā$230,400 / yearFull timeThe Associate Director, Clinical Database Applications and Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert responsible for setting the overall programming strategy including the oversight, guidance, implementation, and management of clinical database applications and reporting. Project Management: Drive successful delivery of clinical data management programming objectives by aligning priorities, streamlining workflows, and optimizing resources in collaboration with cross-functional stakeholders.
Daiichi Sankyo, Inc.Dir Clinical Operations Non-MD Daiichi Sankyo, Inc.Dir Clinical Operations Non-MDBasking Ridge, NJ$201,840ā$302,760 / yearFull timeThey are accountable to ensure their direct reports are delivering to agreed upon study plans, properly identifying risks/mitigations, escalating as appropriate and utilizing data and metrics to put appropriate strategies and plans in place as well as measuring the status/variance of a study and putting appropriate measures in place to course correct where needed. They will ensure their direct reports are meeting required study deliverables including but not limited to oversight of CROs and Vendors and (as applicable) properly leading and ensuring delivery of milestones for the studies within assigned program(s).
AramarkClinical Nutrition Director - RWJBH Children's Specialized AramarkClinical Nutrition Director - RWJBH Children's SpecializedNew Brunswick, NJ$125,000ā$145,000The director is responsible for overseeing all aspects of nutritional care, ensuring that services meet the complex medical, developmental and psychosocial needs of children with unique and chronic health care needs. Bachelor?s degree in dietetics, foods and nutrition, or related area, granted by a U.S. regionally accredited college or university, or foreign equivalent.
Dialysis Clinic, Inc.Dialysis Nurse Manager Dialysis Clinic, Inc.Dialysis Nurse ManagerStaten Island, NY$93,600ā$130,000 / yearDCIās Differentiator:Since opening the first clinic 50 years ago in Nashville, Tenn., our Dialysis Clinic, Inc. family has grown to be the nationās largest nonprofit dialysis provider with more than 270 locations in 30 states, serving nearly 14,000 patients each day. Join DCI today to build relationships and gain fulfillment serving individuals in our comfortable clinical setting with a lower caregiver-to-patient ratio than other providers.
Jefferson HealthNewCT Technologist Jefferson HealthCT TechnologistBristol, PAJefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University , home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students.
Jefferson HealthNewRadiology Technician Jefferson HealthRadiology TechnicianBristol, PAJefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University , home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students.
Dassault SystĆØmesVP of Product - Patient Experience Dassault SystĆØmesVP of Product - Patient ExperienceNew York, NY$216,000ā$288,000 / yearCelebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million users trust Medidatas seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster.
Daiichi Sankyo, Inc.Associate Director PV Quality, Americas Daiichi Sankyo, Inc.Associate Director PV Quality, AmericasBasking Ridge, NJ$150,800ā$226,200 / 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.
Dassault SystĆØmesVP Professional Services, Study Experience Dassault SystĆØmesVP Professional Services, Study ExperienceIselin, NJ$216,000ā$288,000 / yearCelebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. Experience: A minimum of 15 years of progressive experience in professional services, client services, or clinical operations within the life sciences industry (e.g., at a CRO, eClinical/SaaS vendor, Pharma, or Biotech).
Daiichi Sankyo, Inc.Head of Global Biostatistics Daiichi Sankyo, Inc.Head of Global BiostatisticsBasking Ridge, NJ$271,500ā$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.
Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage) Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage)Basking Ridge, NJ$168,000ā$252,000 / yearFull timeProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Dassault SystĆØmesDirector, Offering Management Dassault SystĆØmesDirector, Offering ManagementNew York, NY$135,000ā$180,000 / yearCelebrating over 25 years of ground-breaking technological innovation across more than 38,000 trials and 12 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million registered users across approximately 2,300 customers trust Medidatas seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster.
Dassault SystĆØmesGrowth Marketing Director, Study Experience Dassault SystĆØmesGrowth Marketing Director, Study ExperienceNew York, NY$135,000ā$180,000 / yearCelebrating over 25 years of ground-breaking technological innovation across more than 38,000 trials and 12 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million registered users across approximately 2,300 customers trust Medidatas seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster.
RWJBarnabas HealthNewRWJBarnabas Health is Seeking a Medical Oncologist in Central and Northern New Jersey RWJBarnabas HealthRWJBarnabas Health is Seeking a Medical Oncologist in Central and Northern New JerseyNew Brunswick, NJRWJBarnabas Health, the largest and most comprehensive integrated healthcare system in New Jersey, and a proud partner of Rutgers Cancer Institute of New JerseyāNew Jerseyās only NCI-designated Comprehensive Cancer Centerāis actively recruiting a full-time Attending Medical Oncologist specializing in Genitourinary (GU) Malignancies to join our dynamic oncology team. Our partnership with Rutgers University creates the stateās largest academic healthcare system dedicated to providing high-quality patient care, leading-edge research, and world-class health and medical education, further advancing our mission of providing high-quality healthcare in New Jersey.
RWJBarnabas HealthNewRWJBarnabas Health is Hiring Hematologists/Oncologists Across New Jersey! RWJBarnabas HealthRWJBarnabas Health is Hiring Hematologists/Oncologists Across New Jersey!New Brunswick, NJOur partnership with Rutgers University creates the stateās largest academic healthcare system dedicated to providing high-quality patient care, leading-edge research, and world-class health and medical education, further advancing our mission of providing high-quality healthcare in New Jersey . With 12 acute care hospitals, 3 children's hospitals, a growing number of our outpatient facilities and physician practices, our healthcare system is committed to providing the highest quality of patient care and health education to the community and region.
CellectisSenior Director, Biostatistics CellectisSenior Director, BiostatisticsNew York, NY$220,000ā$240,000 / yearIn collaboration with functional leads, ensure that the execution of clinical trials, (specifically data capture, cleaning) delivers quality and timely ongoing and final databases, develop strategies to minimize the cost of clinical trial execution in delivering quality clinical trial data and ensure that clinical trial systems used in the running of clinical trials are effectively linked to avoid conflicting information. Minimum 15 years of experience in leading biostatistics in clinical research (at various levels and in different capacities), including having built the biostatistics function and 5 years managing a biostatistical group working on all phases of clinical research and drug development.
BMS Family Health and Wellness CentersNewInfectious Disease Physician BMS Family Health and Wellness CentersInfectious Disease PhysicianBrooklyn, NY$285,000ā$300,000 / yearDescription:The Infectious Disease Physician (IDP) is an expert in infectious disease management, responsible for delivering advanced and comprehensive clinical and preventative care, intervention strategies, and multidisciplinary care coordination to improve community health, patient outcomes, and the quality of life for patients living with HIV/AIDS, Hepatitis B (HBV), Hepatitis C (HCV), and related infectious diseases to diverse, underserved, high-risk populations. Coordinate care with hepatologists, infectious disease specialists, pharmacists, behavioral health providers, case managers, and social workers.
TravelNurseSourceNewTravel Nurse RN - Surgical Intensive Care Unit - $2,417 per week in New York City, NY TravelNurseSourceTravel Nurse RN - Surgical Intensive Care Unit - $2,417 per week in New York City, NYNew York City, NY$2,417.04ā$2,417.04RN LicenseBLS2 years of Post Open Heart and Cardiac Care Unit experienceMin 2 years RN experience1 year travel experience for Travel positions, not required for Per Diem positionsEPIC experience highly preferredAvg Unit Census = 1726 Beds in UnitStaffing Guidelines 1:23x12 Schedule with weekends required null RequiredEXCELLENT ORGANIZATIONAL SKILLSICUAdditionalEducation: Bachelor of Science with a major in nursing preferred. Role models the tenets of Mount Sinai Relationship Centered Care (MSHRCC) through facilitation of the following actions including, but not limited to, Admission Welcome, Bedside shift Report, HELP (High Risk Medications, Equipment, Lines/Drains/Airway, Pain and Plan of Care) AM/PM Care, 5 Minute Sit Down, Purposeful Hourly Rounding, Medication Review, Discharge Wrap Up, and MD/RN Unit Collaboration.2.
TravelNurseSourceNewTravel Nurse RN - Long-Term Care - $2,417 per week in New York City, NY TravelNurseSourceTravel Nurse RN - Long-Term Care - $2,417 per week in New York City, NYNew York City, NY$2,417.04ā$2,417.04Role models the tenets of Mount Sinai Relationship Centered Care (MSHRCC) through facilitation of the following actions including, but not limited to, Admission Welcome, Bedside shift Report, HELP (High Risk Medications, Equipment, Lines/Drains/Airway, Pain and Plan of Care) AM/PM Care, 5 Minute Sit Down, Purposeful Hourly Rounding, Medication Review, Discharge Wrap Up, and MD/RN Unit Collaboration.2. RN LicenseBLS2 years of cardiology, tele, VAD experienceMinimum 2 years RN experience1 year travel experience for Travel positions, not required for Per Diem positionsEPIC experience highly preferred null RequiredGREAT ORGANIZATIONAL SKILLSAdditionalEducation: Bachelor of Science with a major in nursing preferred.
Hackensack Meridian HealthUrogynecologist Hackensack Meridian HealthUrogynecologistJersey City, NJCollaboration: Develop and nurture professional relationships with physicians and staff at JSUMC and other Hackensack Meridian Health (HMH) campuses, including Ocean University Medical Center (OUMC), to promote practice growth to Bayshore Medical Center (BMC). ? The posted rate of pay in this job posting is a reasonable good-faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
RWJBarnabas HealthNewAdult Congenital Heart Disease (ACHD) Cardiologist - Medical Director RWJBarnabas HealthAdult Congenital Heart Disease (ACHD) Cardiologist - Medical DirectorNewark, NJOur partnership with Rutgers University creates the stateās largest academic healthcare system dedicated to providing high-quality patient care, leading-edge research, and world-class health and medical education, further advancing our mission of providing high-quality healthcare in New Jersey. With 12 acute care hospitals, 3 children's hospitals, a growing number of our outpatient facilities and physician practices, our healthcare system is committed to providing the highest quality of patient care and health education to the community and region.
Hackensack Meridian HealthPulmonologist Hackensack Meridian HealthPulmonologistLinden, NJThe minimum base salary for this position is $260,602 The posted rate of pay in this job posting is a reasonable good-faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. Hackensack Meridian Health is seeking a dedicated and skilled, board-certified/board-eligible general Pulmonologist to join our thriving outpatient practice in Linden, NJ.
Mount Sinai Health SystemClinical Research Manager Licensed (RN) - Medicine Clinical Trials Office Mount Sinai Health SystemClinical Research Manager Licensed (RN) - Medicine Clinical Trials OfficeNew York, NY$95,450ā$143,175 / yearThe Clinical Trials Office is seeking a highly skilled Clinical Research Nurse manager to lead and support and support a growing portfolio of cellular therapy clinical research, with primary focus on non-malignant CAR-T and cellular therapy studies, while providing transitional collaboration of malignant Bone Marrow Transplant (BMT)/Cellular Therapy programs. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
The Rogosin InstituteClinical Assistant The Rogosin InstituteClinical AssistantNew York, NY$25ā$30 / hourThe Rogosin Institute is an independent not-for-profit medical care and research organization affiliated with New York Presbyterian Hospital and Weill Cornell Medicine. Under the supervision of a registered nurse, the Clinical Assistant participates in the delivery of patient care services by direct patient care and supportive services.
Mount Sinai Health SystemClinical Trials Manager-Center for Psychedelic Psychotherapy and Trauma Research Mount Sinai Health SystemClinical Trials Manager-Center for Psychedelic Psychotherapy and Trauma ResearchNew York, NY$104,995ā$157,492 / yearPlan and oversee regulatory activities for development of psychedelic assisted psychotherapy and other clinical trials; provide expertise and strategy ā¢ Based on deep understanding of clinical trial operations and management of clinical trials, you will be responsible for preparation of study protocols, case report forms, patient consent forms, study monitoring procedures, internal review board submission documents, clinical study reports, case study reports as well as study site contracts for FDA regulatory trials, investigator-initiated trials and pharma partner trial projects. ā¢ Attention to detail ā¢ Excellent oral and written communication skills ā¢ Well organized with project and time management skills; ability to plan and coordinate many moving pieces to achieve results, especially the development of new projects ā¢ Ability to work as a member of a team ā¢ Expertise in clinical trials required; experience with medical and/or psychiatric research, and academic settings, a plus ā¢ Sense of mission.
Spyre Therapeutics IncClinical Trial Manager, Clinical Operations Spyre Therapeutics IncClinical Trial Manager, Clinical OperationsNY$135,000ā$155,000 / yearThe CTM will collaborate closely with internal R&D team members in addition to external CRO partners to drive successful trial execution to advance the development of our cutting-edge antibody conjugate portfolio ensuring efficacy, safety, and regulatory success. A minimum of 5 years of clinical research experience within the pharmaceutical or biotechnology industry, with at least 2+ years managing early phase clinical trials; managing global clinical trials a plus.
Lexeo Therapeutics IncClinical Trial Manager/Senior Clinical Trial Manager Lexeo Therapeutics IncClinical Trial Manager/Senior Clinical Trial ManagerNew York, NY$143,350ā$180,000 / yearOur lead program, LX2006, targets cardiomyopathy associated with Friedreich's Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases.
Agilent Technologies IncSr. Clinical Trials Manager Agilent Technologies IncSr. Clinical Trials ManagerNJMonitor and review study budget and data management activities, such as PRF development, training, and facilitating query resolution with proper documentation ā¢ Support monitoring efforts by setting quality and compliance goals by overseeing and approving study monitoring plans, may review, suggest edits and approve monitoring trip reports ā¢ Contribute to contract review and negotiations with outside vendors and study sites or laboratories ā¢ Mentor CTMs and CRAs ā¢ Demonstrate an ability to influence others to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process Qualifications Qualifications: ā¢ Bachelors degree or higher, or equivalent credentials ā¢ Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements ā¢ Strong interpersonal skills (verbal and written), organizational, and prioritization skills, able to communicate at multiple levels of an organization and with sponsors/clients. Primary Responsibilities (all levels): ā¢ Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out ā¢ Serve as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetings ā¢ Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable ā¢ Develop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materials ā¢ Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6.
Actalent IncNewClinical Trial Manager Actalent IncClinical Trial ManagerPrinceton, NJRemote$80ā$84 / hourThe Clinical Trial Manager drives database lock readiness, oversees CROs and vendors, and ensures high-quality data and documentation that support regulatory submissions. The environment is that of a growing, fast-paced biotech organization focused on addressing unmet medical needs, offering high visibility with senior leadership and significant influence over pivotal Phase 3 trial outcomes.
Precision Medicine Group LLCClinical Research Associate II - FSP Precision Medicine Group LLCClinical Research Associate II - FSPNY$91,500ā$137,300 / yearEssential functions of the job include but are not limited to: Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements.
Mount Sinai Health SystemNewClinical Research Coordinator II - Public Health Research Mount Sinai Health SystemClinical Research Coordinator II - Public Health ResearchNew York, NY$66,199.99ā$90,000.04 / yearWe are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
Genmab ASSenior Clinical Trial Manager Genmab ASSenior Clinical Trial ManagerPrinceton, 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.
Genmab ASClinical Trial Manager Genmab ASClinical Trial ManagerPrinceton, 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.
Shionogi Inc.Senior Manager, Clinical Monitoring Oversight Shionogi Inc.Senior Manager, Clinical Monitoring OversightFlorham Park, New Jersey$135,000ā$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).
Shionogi & Co LtdSenior Manager, Clinical Monitoring Oversight Shionogi & Co LtdSenior Manager, Clinical Monitoring OversightFlorham Park, NJ$135,000ā$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).