Clinical 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.
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.
NewClinical Research Associate, Full Service 5PY IQVIA RDS Inc.Clinical Research Associate, Full ServiceParsippany, NJ$47,400–$169,300 / yearEnsure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
NewClinical Monitoring Associate 5PY IQVIA RDS Inc.Clinical Monitoring AssociateMountain Lakes, NJ$47,400–$169,300 / yearEnsure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
NewDialysis Clinical Manager Registered Nurse - RN Fresenius Medical CareDialysis Clinical Manager Registered Nurse - RNDover, NJ$111,000–$185,000 / yearFacilitate timely workup of patients for access management, dialysis services, patient education, hospitalizations, and kidney transplantation as appropriate, and ensures coordination of care with the multidisciplinary renal team. Demonstrated leadership competencies and skills for the position, including excellent communication, customer service, continuous quality improvement, relationship development, results orientation, team building, motivating employees, performance management, and decision making.
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).
Clinical Project Associate Canfield Scientific, Inc.Clinical Project AssociateParsippany-Troy Hills, NJFull timeAn ideal candidate for our Clinical Project Associate position is an individual who can prioritize and multitask, is experienced in windows-based computer applications, and possesses strong communication skills. The right individual will have strong time management skills and works well in a fast-paced environment.
Supervisor, Clinical Triage (RN) - Access Center, General Surgery/Weight Management/Derm/Urology (PA & NJ Residents Only) St. Luke's Health Network, Inc.Supervisor, Clinical Triage (RN) - Access Center, General Surgery/Weight Management/Derm/Urology (PA & NJ Residents Only)Allentown, PAFull timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. Ensures PEPs and CTSs are properly equipped with necessary technology, resources, and tools required to address patient inquiries and/or triage patients and address clinical patient messages efficiently.
Supervisor, Clinical Triage (RN)- Access Center; Endocrinology/Nephrology/Oncology/Palliative Care (PA & NJ Residents Only) St. Luke's Health Network, Inc.Supervisor, Clinical Triage (RN)- Access Center; Endocrinology/Nephrology/Oncology/Palliative Care (PA & NJ Residents Only)Allentown, PAFull timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. Ensures PEPs and CTSs are properly equipped with necessary technology, resources, and tools required to address patient inquiries and/or triage patients and address clinical patient messages efficiently.
Supervisor, Clinical Triage (RN) Connect to Care - Access Center PA/NJ residency St. Luke's Health Network, Inc.Supervisor, Clinical Triage (RN) Connect to Care - Access Center PA/NJ residencyAllentown, PAFull timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. Ensures PEPs and CTSs are properly equipped with necessary technology, resources, and tools required to address patient inquiries and/or triage patients and address clinical patient messages efficiently.
Clinical Research Coordinator I (PA/NJ residents only) St. Luke's Health Network, Inc.Clinical Research Coordinator I (PA/NJ residents only)Bethlehem, PAFull timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. Bachelor’s degree required; will accept Associates degree or High School degree with equivalent clinical research experience (3 years) with 1-2 years coordinator and/or data management experience highly preferred.
Clinical Research Coordinator I (PA/NJ Residents Only) St. Luke's Health Network, Inc.Clinical Research Coordinator I (PA/NJ Residents Only)Bethlehem, PAFull timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. Bachelor’s degree required; will accept Associates degree or High School degree with equivalent clinical research experience (3 years) with 1-2 years coordinator and/or data management experience highly preferred.
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.
Senior Director, Clinical Development Daiichi Sankyo, Inc.Senior Director, Clinical DevelopmentBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. 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.
Senior Director, Clinical Development - Hematology Daiichi Sankyo, Inc.Senior Director, Clinical Development - HematologyBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. 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.
Senior FDA Attorney JobotSenior FDA AttorneyPine Brook, NJRemote$250,000–$400,000 / yearThis is a senior-level opportunity for an attorney with at least 10 years of substantive FDA experience who is prepared to advise clients on sophisticated regulatory, compliance, transactional, and enforcement matters involving pharmaceuticals, compounding pharmacies, drug and device manufacturers, clinical trials, dietary supplements, veterinary products, and other FDA-regulated businesses. The firm is focused exclusively on healthcare and life sciences and represents clients across the full healthcare ecosystem, including pharmacies, physician groups, hospitals, ambulatory surgery centers, laboratories, manufacturers, suppliers, ancillary service providers, and emerging healthcare businesses.
NewStudy Delivery Lead, Clinical Operations Daiichi Sankyo, Inc.Study Delivery Lead, Clinical OperationsBasking Ridge, NJ$171,120–$256,680 / yearFull timeThe SDL fosters an environment where the core study team maximizes their expertise and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other governance level as needed The SDL will have regular interactions with key internal and external stakeholders to discuss project status, escalate issues, and troubleshoot inquiries. The Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality and per planned timelines.
Clinical Manager, Infusion Center (Full Time, Days) St. Luke's Health Network, Inc.Clinical Manager, Infusion Center (Full Time, Days)Stroudsburg, PAFull timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. Develops, evaluates and adjusts current and future staffing needs in collaboration with other Network Infusion Centers and/or Director of Infusion Services to respond to the needs of the patients served in these departments.
Manager, Global Vendor Quality, Global R&D & PV QA Daiichi Sankyo, Inc.Manager, Global Vendor Quality, Global R&D & PV QABasking Ridge, NJ$127,280–$190,920 / yearFull timeThis position focuses on operational execution, oversight, and continuous improvement of vendor quality activities, contributing subject-matter expertise while working under the direction of senior vendor quality leadership. The Manager, Global Vendor Quality (Global R&D & PV QA) supports the development, implementation, and execution of the GCP/GLP/GVP vendor quality program across Daiichi Sankyo group companies.
Clinical Coordinator Hospice St. Luke's Health Network, Inc.Clinical Coordinator HospiceBethlehem, PAFull timeIndividually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. Demonstrates Performance Improvement in the following areas as appropriate: Clinical Care/Outcomes, Customer/Service Improvement, Operational System/Process, and Safety.