- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …SPARC. Main responsibilities will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as ... degree in Science/Pharma/Technology Discipline with a minimum of 10 years of clinical data management experience in Pharma/Biotech industriesA minimum… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …on dermatology, ophthalmology and onco-dermatology. Description: Sun is seeking a Sr. Manager , Clinical Outsourcing within its Clinical Outsourcing Team ... in Princeton, NJ. The Sr. Manager , Clinical Outsourcing will report into Sr. Director, Clinical... trial outsourcing, vendor selection and contract negotiation, vendor management , and reporting process for Sun Pharmaceutical's clinical… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …analysis implementation and interpretationReview of case report forms (CRFs), data management plans, data specifications and clinical study reports, ... Senior Manager , Biostatistics This position reports to the local area Lead within Biostatistics and Data Management (BDM) group at SPARC. The main… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study Reports).Leads and ... diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical ... (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection... Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in one or more clinical trial operations functions / sub-functions ( Data Management , Biostatistics, Clinical Science) preferred Travel:Ability to travel ... research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is… 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 ... Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... of the Novo Nordisk Inc., (NNI) Procurement Methodology through Category Management and Strategic Sourcing activities. This position will ensure the acquisition… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... from external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders across CMR to plan, ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data ... data review listings and reports to support Data Management and clinical teams.Develop,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … stewardship and governance processes, data cataloging data standards, data quality, and data management .- Develop and implement strategies for ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work...program, data stewardship program or similar intent data management program focused on setting standards,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …negotiation, preparation, and execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting process, review and ... management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts preferred.Demonstrated ability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with strong preference for study feasibility, and/or study design optimization and/or clinical operations project management preferably with a sponsor company at ... This position is required to work within a team focused on process, data /insight packages, outsourcing, and innovation. Depending on business needs this position may… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis ... Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including experience in one or more key functions (eg, clinical research, clinical operations, data management , biostatistics, project management ) ... research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …portfolio or specific therapeutic areas from Phase 1 through life cycle management . Provides oversight of statistical activities performed by direct reports or staff ... the global function to support drug development and life cycle management . Represents the function in global regulatory/heath authorities' meetings. High-level… more
- Bristol Myers Squibb (Princeton, NJ)
- …clinical trials from study start to database Lock . **Position Summary:** The Senior Manager , Clinical Data Management is a leadership role considered ... and in their personal lives. Read more: careers.bms.com/working-with-us . **Functional Area Description:** Clinical Data Management k ey focus is to ensure… more
