Senior Project Manager, eCOA Implementation IQVIASenior Project Manager, eCOA ImplementationDurham, PennsylvaniaIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. Communicate customer requirements to the product management teams, advocate on the customer’s behalf, and communicate the status of enhancement requests to customers.
Manager, Expanded Access Program Celldex TherapeuticsManager, Expanded Access ProgramHampton, New Jersey$116,156–$150,852 / yearReporting to Executive Director, Clinical Operations, this role serves as the primary representative responsible for overseeing outsourced EAP operations, ensuring vendor performance, regulatory compliance, cross-functional alignment, and an exceptional experience for physicians and patients requesting access to investigational products outside of clinical trials. The Manager will partner closely with Clinical Development, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Supply Chain, Quality, Legal, and external service providers to ensure expanded access requests are evaluated, processed, and managed efficiently and compliantly across multiple regions.
Manager, Global Medical Affairs Operations - Contract Summit Therapeutics IncManager, Global Medical Affairs Operations - ContractPrinceton, NJHARMONi: 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. The Manager will support cross-functional coordination, documentation, meeting logistics, and operational reporting across activities such as congress planning, advisory boards, patient advocacy initiatives, and other key Global Medical Affairs projects.
Senior Local Trial Manager (Sponsor Dedicated, Multiple Therapeutics) IQVIA Holdings IncSenior Local Trial Manager (Sponsor Dedicated, Multiple Therapeutics)Bethlehem, PA$93,100–$232,800 / yearEnsures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing strategic input to study-level documents and independently leading/coordinating local team activities in compliance with SOPs, other procedural documents, and applicable regulations. Ensures Inspection Readiness by maintaining complete, accurate, and timely data and essential documents in systems utilized for trial management (e.g., CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements.
Evidence Generation Manager ZSEvidence Generation ManagerPrinceton, New Jerseynbsp: This role will work directly within the Medical & Evidence Generation space, partnering closely with stakeholders across Drug Development, Clinical Operations, Real-World Evidence (RWE), Medical Affairs, Payers, Providers, and Biopharmaceutical organizations to design and execute high-impact strategic and operational initiatives that accelerate evidence generation and improve healthcare outcomes. • Drive strategic business development activities, including identifying opportunities, building executive relationships, developing proposals, and expanding client partnerships across R&D, Clinical Development, Medical Affairs, and Evidence Generation.
Senior Director Quant Pharm Penfield Search PartnersSenior Director Quant PharmPrinceton, NJThe Quantitative Pharmacology group is responsible for the oversight over drug development aspects related to clinical pharmacology and pharmacometrics of clinical development candidates, working in close collaboration with nonclinical and clinical functional areas. Development and execution of model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulations, and quantitative systems pharmacology (QSP) modeling.
NewQuality Risk Management Manager Pride GlobalQuality Risk Management ManagerPrinceton, NJ$50–$60 / hourResponsibilities: Partner closely with Clinical Operations, Data Management, Pharmacovigilance, Regulatory Affairs, CROs, and other R&D stakeholders to identify compliance risks, develop performance metrics, conduct root cause analysis, and drive continuous process improvement. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.
Senior Product Manager, Infection Prevention Solutions Job Details | Olympus Corporation Of The Americas OlympusSenior Product Manager, Infection Prevention Solutions Job Details | Olympus Corporation Of The AmericasCenter Valley, PAExecute the commercial business plan including: 1) the launch of new products, 2) development of value propositions and messaging, 3) communication of key selling messages using all available and relevant channels, and 4) development and execution of clinical strategy to differentiate company products. Experience in interacting with a diverse cross functional team, strong prospecting skills, self-starter, capable of independent action, detail oriented, multi-task/time management, ability to internalize technical concepts, products and services.
Senior Product Manager, Infection Prevention Solutions Olympus CorpSenior Product Manager, Infection Prevention SolutionsPAExecute the commercial business plan including: 1) the launch of new products, 2) development of value propositions and messaging, 3) communication of key selling messages using all available and relevant channels, and 4) development and execution of clinical strategy to differentiate company products. Experience in interacting with a diverse cross functional team, strong prospecting skills, self-starter, capable of independent action, detail oriented, multi-task/time management, ability to internalize technical concepts, products and services.
IRB Operations Manager VitaliefIRB Operations ManagerPrinceton, NJFull 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. The ideal candidate will bring significant experience in IRB administration, human subjects research protections, federal research regulations, and program operations, with the ability to quickly assess processes, provide leadership continuity, and maintain high-quality service delivery.
Nurse Manager - Med Surg/Telemetry - Full Time, Day - Jefferson Bucks Thomas Jefferson UniversityNurse Manager - Med Surg/Telemetry - Full Time, Day - Jefferson BucksBucks County, 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.
Senior Manager, R&D Data, Data Science, And AI - Digital Health For Neuropsychiatry Johnson & JohnsonSenior Manager, R&D Data, Data Science, And AI - Digital Health For NeuropsychiatryTitusville, NJRemote$137,000–$235,750 / yearDigital Endpoints & Tools: Execute the neuropsychiatry-focused digital health strategy by applying AI/ML, modeling, and longitudinal analytics to support patient stratification, endpoint development, and clinical trial optimization, in partnership with disease experts, statisticians, and platforms and clinical teams on study design and validation of digital measures, balancing their informativeness with low clinical burden for patients and study teams. All Job Posting Locations: Cambridge, Massachusetts, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America.
Senior Manager, R&D Data, Data Science, and AI - Digital Health for Neuropsychiatry Johnson & JohnsonSenior Manager, R&D Data, Data Science, and AI - Digital Health for NeuropsychiatryTitusville, NJRemote$137,000–$235,750 / yearDigital Endpoints & Tools: Execute the neuropsychiatry-focused digital health strategy by applying AI/ML, modeling, and longitudinal analytics to support patient stratification, endpoint development, and clinical trial optimization, in partnership with disease experts, statisticians, and platforms and clinical teams on study design and validation of digital measures, balancing their informativeness with low clinical burden for patients and study teams. All Job Posting Locations: Cambridge, Massachusetts, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America.
Research Patient Recruitment Coordinator St. Luke's University Health NetworkResearch Patient Recruitment CoordinatorBethlehem, PAIndividually 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. Apply inclusion and exclusion criteria to generate targeted lists of potential participants, according to IRB-approved pre-screening and recruitment methods, and communicate findings to local trial coordinators for eligibility confirmation and coordination of next steps.
Quality Specialist I Logistics Parexel International CorpQuality Specialist I LogisticsQuakertown, PAWith 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. With diverse teams and continuous learning opportunities, the Quality Specialist I can explore career paths and expand skills across clinical research and supply chain operations.
Director, Medical Safety Assessment Physician, Neuroscience Bristol Myers SquibbDirector, Medical Safety Assessment Physician, NeurosciencePrinceton, NJ$286,560–$347,244 / yearOversee, prepare and/or review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]). Based 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.
Director, Medical Safety Assessment Physician Bristol-Myers Squibb CoDirector, Medical Safety Assessment PhysicianPrinceton Pike, NJ$286,560–$347,244 / yearOversee, prepare and/or review aggregate safety review documents (eg, Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (eg, protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (eg, clinical trial applications [CTA], marketing authorization applications [MAA]). Based 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.
Medical Director (Oncology) Genmab ASMedical Director (Oncology)Princeton, 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.
Senior Director, Quantitative Pharmacology Sun Pharmaceutical Industries LtdSenior Director, Quantitative PharmacologyPrinceton, NJ$215,500–$239,500 / yearThe Quantitative Pharmacology group is responsible for the oversight over drug development aspects related to clinical pharmacology and pharmacometrics of clinical development candidates, working in close collaboration with nonclinical and clinical functional areas. Development and execution of model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulations, and quantitative systems pharmacology (QSP) modeling.
NewSenior Director, TMF Services TransPerfectSenior Director, TMF ServicesPrinceton, New JerseySummary: The Senior Director, TMF Services is a senior leadership role responsible for the end-to-end management and strategic direction of the TMF Services division, overseeing service delivery, operational growth, and the continuous expansion of service offerings. The Senior Director will lead the strategic growth, operational excellence, and delivery of LMK's Trial Master File (TMF) services while building strong relationships across LMK, TransPerfect, and its global client base.