- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical device, pharmaceutical company, or similar environment (eg, CRO) requiredExperience with clinical data standards requiredDaiichi Sankyo, Inc. is an equal ... according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data … more
- DivIHN Integration Inc (Columbus, OH)
- …science undergraduate work for example. Skills: Some industry experience is desirable. Clinical knowledge to apply to adverse event data collection and/or ... Pharma As an individual contributor, with guidance from the manager /team, functions to support the medical safety team by...to present case data , medical and scientific data orally and in writing. Clinical Monitor… more
- Option Care Health (Columbus, OH)
- …patients with acute and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health is re-imagining the ... and materials that reflect the analysis of prior marketing data to build on the success or failure of...annual marketing statistics which will be received in raw data form. Reports must be processed for meaningful interpretation… more
- Merck & Co. (Rahway, NJ)
- …, biomarker data , and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as assigned.- ... Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Manager , Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global ... Clinical Data Standards (GCDS) Sr....and Reference Data Management within the Global Data Management & Standards (GDMS) organization, the Manager … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lifecycle - Collaborates with Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify ... a project manager for other activities involving assigned product(s) or clinical studies, as needed Qualifications: Successful candidates will be able to meet… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focused approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within North America Clinical Development (NADO). ... 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
- Merck & Co. (North Wales, PA)
- … trial team.Leading medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaborations with the Clinical ... in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , 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)
- …rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies, thereby developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor ... data standards is required.Knowledge of CDISC and SDTM and industry standard data collection practices. Clinical data management experience in a medical… 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
- Merck & Co. (North Wales, PA)
- …(eg, database set up)Lead medical monitoring team in review and interpretation of clinical data /medical protocol deviations in collaboration with the Clinical ... the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study… more
- Novo Nordisk Inc. (San Antonio, TX)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesManage external vendors ... centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of... data review listings and reports to support Data Management and clinical teams.Develop, implement and… more
- Merck & Co. (North Wales, PA)
- …Clinical Trial Team (CTT)May work closely with the Medical Writer on clinical /scientific and regulatory documents and the Study Manager on study ... and prioritization skillsStrong analytical skills with the ability to interpret clinical trial data and synthesize conclusionsInteract with key stakeholders… 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 ... 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)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical , product, and vendor data and Identify and… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... responsible for the supply planning and inventory management of clinical supplies required to support global clinical ...Affiliate & CSC Matrix Team Meetings providing all relevant data and documentation prior to each meeting, highlighting any… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , 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
