- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data ... level. Primary activities include, but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Collaborates with Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify potential ... surveillance and risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead , Product Safety Lead (PSL), … 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
- 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.- ... creates and ensures the successful execution of the clinical data management strategy for assigned trials...guidance of more senior staff, may serve as the data management lead or perform a support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …alignment on key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish strong partnership with ... veterans and people with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… 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 ... EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical...before database lock; collaborates with lead statistician on SAP update, as needed. Provides input… 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)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for ... role will consist of these components including: Expand and lead our Data Stewardship Working Group (DSWG)...management.- Develop and implement strategies for cleansing and standardizing data , with a focus on eg, clinical ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... In this key role, the candidate will have to lead a complex, global team in charge of a...a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing… more
- Eisai, Inc (Nutley, NJ)
- …to evaluate biomarkers across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as a ... team as an extended part of committee. Advise Study Data Manager on complex vendor management issues...standard data collection practices preferred- 7+ years Clinical data management experience in a medical… more
- Merck & Co. (North Wales, PA)
- …relationships with both internal and external groups. The Associate Director Pub Manager is expected to: Lead cross-functional Publication Teams for a number ... and meeting notes.With minimal oversight, provide therapeutic area expertise to lead scientific strategy discussions around appropriate data dissemination… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... 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
- Lundbeck (White Plains, NY)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the...Ability to use digital tools and apply customer and data -based insights to build opportunities, develop strategy & tactics… more
- Lundbeck (South Bend, IN)
- …neurology and psychiatry. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales ... and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers...Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the...creation, and marketing execution. Relationships Reports to HCP Experience Lead . Collaborates with key external and internal cross-functional teams,… more
- Tris Pharma (Monmouth Junction, NJ)
- …portfolio of best-in-class ADHD medicines and an exciting pipeline of clinical -stage programs across Pain, Psychiatry, and Neurology. Our proprietary technologies ... an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior Manager , Business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work closely with ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure high data quality and proactive detection and resolution of issues. Lead effective communications within the GPT, by interacting with other GxP QA ... System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to… more
- Aequor (Thousand Oaks, CA)
- …of regulatory submission documents that comply with global regulatory standards. Write or lead all aspects of the writing of clinical study reports and ... FULLY REMOTE final BR - / hour Regulatory Writing Manager In this vital role you will prepare and...Investigator Brochures for products in all phases of clinical development (phases 1-4) Write CTD sections including the… more
