- IQVIA (Parsippany, NJ)
- …other required study documentation. * Act as a mentor for clinical staff including conducting co-monitoring and training visits. * Collaborate and liaise with ... Overview Perform monitoring and site management work to ensure that sites are conducting the study (ies) and reporting study data as required by the study … more
- Sumitomo Pharma (Trenton, NJ)
- …We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, and a ... PK/PD, clinical pharmacology and drug-metabolism expertise to project teams. + Design clinical pharmacology components of clinical studies . + Create … more
- Actalent (Parsippany Troy Hills, NJ)
- Job Title: Senior Clinical Study Manager The Senior Clinical Study Manager is responsible for ensuring the successful execution and delivery of ... clinical studies . Responsibilities + Lead the development of clinical study plans, identifying critical path activities and interdependencies. + Create… more
- Merck (Rahway, NJ)
- …manage the entire cycle of late-stage clinical development and studies , including development strategy, study design, initiation, execution, monitoring, ... safety and efficacy as well as new drug applications, clinical study reports, or publication + Participation...of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) + Study Planning and Execution: ... Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. **Responsibilities** + Study Strategy:… more
- Merck (Rahway, NJ)
- …operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). The incumbent must have ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, ... vendors. Supports regular vendor/sponsor discussions to identify risks and ongoing study support. Identifies critical issues which may compromise patient dosing or… more
- Highmark Health (Trenton, NJ)
- …requested. **EXPERIENCE** **Required** + Leading the design, execution and dissemination of clinical and population health reporting, analyses and studies of ... skills to supportthe design, development, execution, dissemination and interpretation of clinical and population health analyses, metrics and reports using … more
- Merck (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications + Participating in internal and joint ... may supervise the activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in… more
- Merck (Rahway, NJ)
- **Job Description** **Role Summary** + Under the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility ... programs + In collaboration with internal teams and external partners, designs studies , authors study protocols, develops measurement questionnaires, case report… more
- J&J Family of Companies (Raritan, NJ)
- … needs, drafting proposals and protocols, and contributing to epidemiology strategy and study conduct across the clinical development program. + May conduct fit ... searching for the best talent for the role of ** Associate Director, Oncology Epidemiology** . We have a preference...+ Conduct literature reviews and synthesis; provide assistance to clinical teams with study design; and identify… more
- Sumitomo Pharma (Trenton, NJ)
- … Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator's Brochures (IB), Investigator communications ... Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or clinical study team meetings and governance committees. + Performs… more
- BeOne Medicines (Pennington, NJ)
- **_General Description:_** Establish a stability program in Quality Control for clinical and commercial phase biologics products in accordance to FDA/EU regulations, ... and BeiGene processes and procedures. Oversee and manage stability studies to deliver scientifically sound GMP test data in...+ Establish and manage the QC stability program for clinical and commercial phase biologics products. + Ensure timely… more
- Hackensack Meridian Health (Hackensack, NJ)
- …diploma/degree in science or healthcare field. + Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or ... Preferred:** + SOCRA-Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical … more
- Humana (Trenton, NJ)
- …illness, surgery or hospitalization. The Value-Based Finance team is seeking a Senior Financial Analytics Developer to work directly with the finance team and ... senior management to validate and craft enterprise-wide initiatives. This...validate and craft enterprise-wide initiatives. This includes budgeting, profitability studies , payer proposals, board-level analyses, and other strategic projects.… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The Associate Director, TLL, Renal Rare Disease, is a field-based, customer facing, non-sales position on Otsuka's Rare Renal team focused on enhancing and improving ... attributes that are critical for success include leadership, strategic thinking, clinical and disease state acumen, strong collaboration, communication, and the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ At the time of implementation of a CDx study /IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data ... diagnostic business partners specifically: + Use of CTA/CDx within clinical trials + Device protocols and SAPs + Device...and risks in written and verbal format to regulatory senior leadership team and other governing bodies required **Travel:**… more
- Sanofi Group (Morristown, NJ)
- …Responsibilities:** + Expert level of statistical and scientific contribution to clinical development plans, studies and submissions activities (when ... **Job Title:** Statistical Project Leader ( Associate Director) **Location:** Morristown, NJ , Cambridge, MA...applicable), with minimal guidance from senior statistical project leader or team leader + Accountable… more
- Bristol Myers Squibb (Madison, NJ)
- …for clinical trials, facilitating the end to end process, providing expertise to clinical study teams and working with them and vendors to implement eCOA to ... their personal lives. Read more: careers.bms.com/working-with-us . **Summary** The Senior Manager, eCOA Management role is essential to the...meet study requirements. Taking responsibility for more complex … more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director, Bioanalytical Biomarker Category Manager will directly report into ... the Specialty Clinical Laboratories global category Director. This position is responsible...on procurement activities, performance metrics, and strategic initiatives to senior leadership. + As an integral member of the… more