- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Clinical Data Management (CDM) serves as Therapeutic Area Head providing Clinical Data Management leadership to Data ... support of Regeneron key development programs. Works with Sr Director and Executive Director to set department...Manager (CCDM) experience. + Minimum of 12+ years of clinical data management experience in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for ... Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with… more
- Bristol Myers Squibb (Princeton, NJ)
- …to the sustainability and success of the BMS R&D pipeline. This role reports to the Director , Clinical Data Management or Associate Director , ... to every treatment we pioneer. Join us and make a difference. The Senior Manager, Clinical Data Management ( Data Management Lead) is a role… more
- Edwards Lifesciences (Trenton, NJ)
- …protocol language and interpret and translate clinical , economic outcomes and results + Clinical data management skills, including data mining, ... of our inspiring journey. As the ** Director , Clinical Affairs ( Clinical Data &...and unmet needs preferred **Additional Skills:** + Proven successful clinical project management skills + Expert understanding… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part ... The Director Clinical Sciences, Hematology, leads in... data review + Ensures consistent first line medical/ clinical data review techniques and conventions across… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …coding support, protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management 5. Work with Biometrics to ... will monitor clinical studies, review and interpret clinical trial data , provide input into ...veteran status, disability or any other legally protected status. Director Clinical Development - Base Salary range… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders communicating ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act ... and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review + Conducts clinical data review per Integrated Data Review Plan (IDRP) + ... ** Director , Clinical Development** **Join a Legacy...(MM): + Provides oversight to the CRO MM for clinical data review activities + May support… more
- Novo Nordisk (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Director , Clinical Informatics in the Clinical Data Science & Evidence (CDSE) department ... of "best practices" in informatics and associated contingencies to include healthcare and clinical data analytics, real-world data sources, data … more
- Bristol Myers Squibb (Princeton, NJ)
- …and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, data ... for the** Clinical Pharmacology Plan + **Lead** design of clinical pharmacology studies and manages data analysis, interpretation, and reporting… more
- Prime Therapeutics (Trenton, NJ)
- …supports a service such as Clinical program development, Clinical product management , Clinical system development & data analysis or other drug ... and drives every decision we make. **Job Posting Title** Clinical Program Development Director /RPh required- REMOTE **Job...pharmacists in a discipline such as Prime UM (Utilization Management ) program development or Clinical reporting and… more
- Actalent (Basking Ridge, NJ)
- Job Title: Director , Clinical SafetyJob Description The Director , Clinical Safety will be responsible for leading overall product safety strategy, safety ... management . This role involves providing safety leadership across clinical studies, post-marketing surveillance, signal detection, and regulatory submissions. The… more
- System One (Basking Ridge, NJ)
- Director Clinical Safety 12 month contract Hourly Pay Max: $100- $120 (dependent on experience) Fully remote Description: The Director , Clinical Safety, ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Science Lead reports through the Clinical Science function which ... provides scientific expertise necessary to design and deliver clinical studies and programs. + Leads the Clinical Science team in the planning and execution of … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...+ Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,… more
- Bristol Myers Squibb (Princeton, NJ)
- …Articulating clinical development strategy + Analyzing, interpreting, and acting on clinical trial data to support development + Serving as principal ... in their personal lives. Read more: careers.bms.com/working-with-us . The Early Clinical Development function is part of a global scientific organization dedicated… more
- Novo Nordisk (Plainsboro, NJ)
- …a difference? The Position Senior, Clinical Informatics leads the functions in the Clinical Data Science & Evidence (CDSE) department of NNI focused on ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management , and EDC extraction configuration + Knowledge of data flow between clinical data management systems, vendor devices and CDR. + Knowledge of ... bold mission. **OBJECTIVES:** Key to Takeda's success is the Clinical Data Engineering team, provides strategic planning,...for reuse for study level configuration tasks. The Associate Director Data Configuration Engineer (DCE) oversees a… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …supplier management activities, and stakeholder engagement activities for the Clinical Laboratories Category as assigned. + Works independently to drive value in ... Accountabilities:** + Accountable for leading, defining, and implementing the global Clinical Laboratories Category strategy to serve global and regional business… more