- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Director , Clinical Development Join a Legacy...Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … data between partners in relation to marketed and clinical products.Strategic Partner Management :Oversees Local/Global PV service providers responsible ... around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a ... of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange Requests for PV Systems Collaborate cross… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, ... Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Certification - Certified MedDRA Coder (CMC) or equivalent preferred Experience:4+ years of clinical data management medical coding experience in a medical ... coding requirements such as eCRF Specifications, listings, coding conventions, Data Management Plan, and dictionary coding synonym...MedDRA, and WHO not DD is requiredWorking knowledge of Clinical trial data systems and/or EDC coding… more
- 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
- 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
- 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
