- Merck & Co. (Rahway, NJ)
- …and regulatory requirements for clinical data standards, technology, and clinical data management disciplines; actively engages in industry forums. ... project management .2+ years' experience working in clinical development or clinical data management .Strong knowledge of the Drug Discovery Process,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team ... Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study...data review process in collaboration with the study team to ensure data qualityParticipates in audits… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and ... rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has...assess and plan for Ph I - III study team delivery and transitions. This includes engagement with feasibility,… more
- Merck & Co. (North Wales, PA)
- …to support drug applications and regulatory submissions to health authorities globally.Trial Data Management (TDM) is a core business capability that focuses ... data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data...strategy to enable the software products within the Trial Data Management area to power the business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … studies from end to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to ... multiple program-level CS Asset Leads who are managing a team of clinical scientists for the writing...or several programs.Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management… more
- Icon VendorPass and Affiliates (Waltham, MA)
- Position Title: Clinical Data ScientistLocation: Waltham, MaPay Rate: $60/hr (+benefits)Assignment Length: 1-year W2 ContractSchedule: HybridIndustry: ... workflows that are flawed or inefficient. In association with data continuum and digital team ensure proper...users/experimental read outs across R&B teams leading to harmonized data management and utilization. Resolve data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... IND.Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management .Lead the creation of the CRO scope… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates...EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …risk minimization plans. Presents assessment to the appropriate forums, including Safety Management Team (SMT) or other cross-functional teams - Collaborates ... with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Product Development Plan and clinical development strategy; Leads Integrated Project Team (IPT) working closely with Global Project Management to ensure ... ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs...Team (IST) representative or IST leader on study team ; Responsible before senior management for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and SDTM and industry standard data collection practices preferred- 7+ years Clinical data management experience in a medical device, pharmaceutical ... as a subject matter expert and contributor to DM data standards team and represents function to...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… more
- Merck & Co. (Rahway, NJ)
- …ensures continuity of site relationships through all-phases of the trial.-Performs clinical study site management /monitoring activities in compliance with ... site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands… 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 ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with… more
- Insmed Incorporated (Bridgewater, NJ)
- …analysis. Collaborate with team in the development and implementation of Data Management activities including development of eCRFs, edit checks, coding, ... will play an important role in working with the team to execute the global clinical development...knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and… more
- Merck & Co. (North Wales, PA)
- …agreements, and other type of agreements related to clinical research.Our Clinical Research and Pharmacovigilance team push the boundaries of global ... GSA Specialist you will work closely with experienced GSA team to:Review Clinical Outcome Assessment (COA) licensing...implementation of COA measures in connection with our company clinical trials through strong project management and… more
- Merck & Co. (Rahway, NJ)
- …or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for understanding ... achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical...commitment to innovation and to our people. As a team , we commit to creating a culture of diversity… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Drives the understanding & delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...minimum of 2 years of direct expertise of site management and logistical execution of clinical trials… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other ... This individual will ensure proactive safety monitoring and risk management through the Safety Management Team...serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...other relevant GOMA functions and the Global Medical Affairs Team . Regional and Functional Support Work with the Functional… more
