- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality ... 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… more
- Novo Nordisk Inc. (WA)
- …the application of those principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills (MS Office, MS Project ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team,… more
- Merck & Co. (Upper Gwynedd, PA)
- … Specialist may be responsible for but not limited to:Job ResponsibilitiesMaintain clinical trial files (including eTMF), project processes, tracking ... trials . Under the oversight of a clinical scientist, study manager , or program lead,...external stakeholders (eg, study sites, committees) in support of clinical trial objectivesCore SkillsPharmaceutical, research, medical, and/or… more
- Merck & Co. (Rahway, NJ)
- …clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... including clinical directors and study managers to lead/support clinical trial scientific activities.Job ResponsibilitiesResponsible for the clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight of the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to ... to conduct of gap & impact assessment and developing project scope and project plans.Work cross-functionally with...of CLIA/CAP regulations and GLP guidelines preferredBasic knowledge of clinical trial design; understanding of the overall… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling...updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label… more
- Aequor (NH)
- …regulatory, medical affairs, marketing, commercial diagnostics, portfolio team lead, global project manager EDUCATION AND EXPERIENCE: Bachelor's degree in Life ... report on project execution and progress against milestones and deliverables Support clinical diagnostic lead in trial start up activities such as vendor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and ... routine basis. Close relationships with Global Market Access and Pricing, the Global Project Teams (GPT) and Core Commercialization Teams (CCT) for launch brands may… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …one-year program. Additional key internal relationships may include MA management, MA project management, Medical Communications, Clinical Trial Management, ... interests on cross-functional teams including, Field Medical Affairs, Medical Operations, Clinical Trial Management, HEOR, Market Access, Marketing and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may include Medical Affairs, Regulatory Affairs, Marketing, Learning & Development, Clinical Trial Management, and Clinical Development. Essential ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations.… more
- Beacon Hill (King Of Prussia, PA)
- Beacon Hill Legal is seeking Clinical Trial Contracts Manager for an opportunity with a global biotechnology company in the greater Philadelphia region. This ... is a long-term temporary position and a great opportunity for professionals with clinical trial contracts experience in the life sciences industry. Candidates… more
- Beacon Hill (King Of Prussia, PA)
- …quick turnaround time for deadlines in clinical trialWill work closely with clinical trial contracts manager and global teamMust have excellent oral ... Beacon Hill Legal is seeking Clinical Trial Contracts Specialists for an...coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation,… more
- DivIHN Integration Inc (Atlanta, GA)
- …SOPs, supervising and performing database development, testing, validation, reviewing and processing clinical trial data to ensure the completeness, accuracy and ... consistency of clinical trials databases. Looking for a person...system exp- not mandatory. Essential Duties AND Responsibilities: Designs clinical trial specific subject Case Report Forms… more
- Arthrex (Naples, FL)
- …development and medical education in orthopedics. Arthrex is actively searching for a Sr. Clinical Data Manager . Join our talented team at a global medical ... the entire data management lifecycle is required Experience working with medical device trials is preferred Knowledge of EDC and Clinical Data Management Systems… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- … regarding the study implementation process.Study Initiation: Plan, organize, implement clinical trials /research studies to effectively meet goals and ensure ... are submitted to sponsor in a timely manner, eg, 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as… more
- Axelon Services Corporation (Princeton, NJ)
- …strategies within a specific therapeutic area(s) and is accountable to support clinical trial vendor partnerships across select or multiple service categories ... of clinical trial activities in R&D. Key Responsibilities:...of projects to meet short-term objectives & adhere to project schedules - Support Outsourcing team in a variety… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …process in line with the approved protocol, including grant sponsored and clinical trial projectsManage and communicate effectively with Research Leadership ... / securely stored in a timely manner, eg, 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as… more
- Northeast Georgia Health System, Inc (Oakwood, GA)
- …facilities policies, practices and standards of care ultimately resulting in improved clinical and financial outcomes. Provides support to SCM Specialists during VAT ... trials and product conversions. Provides support to SCM Buyers...sensitive product substitution. Carries out all directives issued by Manager of Value Analysis on a consistent basis to… more
