- Eisai, Inc (Nutley, NJ)
- …years of relevant programming and application development experience, 5 or more years project management & people management experience Experienced in ... must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess...user support to other areas of Data Operations, Data Management , Clinical Safety Data Review and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams...teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Genmab (NJ)
- …and industry data standards (eg, CDISC/CDASH).Excellent cross-functional communication and project management skills.Experience supporting regulatory filings and ... love to have you join us!The RoleThe Associate Director, External Data Quality Management , is a strategic leadership role within Clinical Data Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. ... Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to… 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 ... roles. Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA,… more
- Genmab (NJ)
- …study are in scope.The Programming Manager will support the Data Management , Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions ... we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring...of data consistenciesSupports specification and pooling of data across clinical trials within the same project .Supports in-house… more
- Merck & Co. (Boston, MA)
- …to detail. Good time management skills as well as demonstrated project management ability.Excellent written and oral communication skills Education Minimum ... Development Sciences (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services… more
- Genmab (NJ)
- …Safety, Medical, Clinical Pharmacology,Translational Research, Medical Writing, Project management , and Regulatory. Responsibilities/tasks - including but ... would love to have you join us!Overview: The Programming Manager supports the development of new therapies by ensuring...database standards. Supports specification and pooling of data across clinical trials within the same project . Supports… more
- ACROBiosystems Inc. (San Diego, CA)
- …management skills, with the ability to prioritize tasks and meet deadlines. Project management experience with the ability to coordinate multiple stakeholders ... proteins and critical reagents/assays to support drug development and clinical applications from target discovery and validation, candidate drug screening… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position requires skills in working in a fast-paced environment, continuous improvement, project management , change management , and risk management . ... and builds and maintains positive relationships with internal/external stakeholders/vendors/partners. Project Management : - Accountable for completion 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 ... Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management . This role fulfills the PV Oversight function in PV deviation … more
- Eisai, Inc (Nutley, NJ)
- …development plans within the clinical development. Works with the clinical , project management , and data manager teams on strategic designs of ... & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management , Statistical Programming Skills, Vendor ManagementEisai… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …priorities.Will be expected to serve as the lead with the vendor & project management requirements for initiative completion.Will partner with the Director, ... Summary:The Associate Director, Oncology Value & Market Dynamics Training Manager is responsible for developing & deploying a strategic...to serve as the lead with the vendor & project management requirements for initiative completion. Will… more
- Genmab (NJ)
- …in data analysis and interpretation to inform strategic decision making, project management , developing study delivery strategies and tactical operational ... competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program.Key contributor to the study's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …policies, regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, ... of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires...risk factors with and for other technical departments (eg, Clinical , Medical, Safety, Data Management , Statistics). This… more
- Aequor (Seattle, WA)
- …plans for process risksAble to manage time and elevate relevant issues to project lead and line management .Detail oriented with excellent verbal and written ... onsite required, days of week are flexible)Job ID: 62721Per manager , the Top 3 - 5 Must Have's a...experience with change control processes, document approvals, and the management of Standard Operating Procedures (SOPs), Work Instructions (WIs),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Aequor (Aliquippa, PA)
- …the solutions of tomorrow Effective communication and command skills Excellent project management skills Good negotiation and facilitation skills Demonstrated ... remote schedule and be available at the committed times. Qualities/characteristics the hiring manager is looking for in candidates to work best with their team:… more
- J&J Family of Companies (Spring House, PA)
- …will be considered as a single submission. **We are searching for the best talent for Manager , Clinical Project Management , Oncology in Spring House, PA; ... Titusville, NJ; or Raritan, NJ.** **Purpose:** The Manager , Clinical Project Management (CPM) is responsible for the creation and management of the… more
- ConvaTec (Lexington, MA)
- … team for Medical and Clinical Affairs, the Clinical Program Manager oversees the project management , planning, execution, tracking, and reporting of ... us on our journey to #ForeverCaring as a Senior Clinical Program Manager , and you won't either....agreed scope and budget + Work with cross functional management , clinical operations teams, and project… more
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