- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CAPA investigations, case review, documentation reviews in collaboration with the ICSR management and CRO /Vendor oversight groups for case processing activities ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...data management plan reviews. Works with ICSR management and CRO /Vendor oversight to manage relationship… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management in governance bodies internally and externally with CRO partners and stakeholders.Liaises with other function heads to ensure effective ... of the CRO governance committee, provides strategic leadership in Data Management related topics and establishes the oversight model for timely and quality… more
- Eisai, Inc (Nutley, NJ)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... eTMF internal reviews, reconciliation and study file archivalPerforms detailed eTMF CRO quality check reviews with follow-up for missing documentation under the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, data...KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …- 11 or more years of experience in RBQM and/or related work experience in pharmaceutical company, Biotech, or similar environment (eg, CRO ). required- 5 or more ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- Eisai, Inc (Nutley, NJ)
- …strategies.Experience in managing and directing related functions such as data management , CRO vendor management , procurement, and contracting.Excellent ... and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… more
- MMS Holdings Inc. (Canton, MI)
- …a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization ( CRO ). We pride ourselves on being a Great Place to Work certified ... culture and industry best employee retention rate. We support the pharmaceutical , biotech, and medical device industries with our proven, scientific approach… more
- REGENXBIO (Rockville, MD)
- …years progressive experience in clinical research management experience in a pharmaceutical , biotechnology, CRO and/or healthcare setting with 1+ year of ... utilizing effective communication across the organization. This position may include line management responsibilities and will also be able and willing to mentor… more
- Olema Oncology (Boston, MA)
- …research / development and manufacturing organizations) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities. ... as a strategic cross-functional partner working closely with the CMO/ CRO labeling specialists, cross-functional project teams including Quality, Regulatory, Clinical… more
- PTC Therapeutics (Warren, NJ)
- …of progressively responsible experience in statistics or statistical programming in a pharmaceutical , biotechnology, CRO or related environment OR a Bachelor's ... progressively responsible experience in statistics or statistical programming in a pharmaceutical , biotechnology, CRO or related environment * Special knowledge… more
- Eli Lilly and Company (Boston, MA)
- …leadership in early development study conduct including study design, safety management plans, protocol writing, regulatory documents, CRO interactions, study ... to those who need them, improve the understanding and management of disease, and give back to our communities...at least 3 years of direct experience in the pharmaceutical industry Preference for LCME accredited trained physicians who… more
- Actalent (Pennington, NJ)
- …preferred). 7+ years of experience in clinical trial management within the pharmaceutical , biotech, or CRO industry. Proven experience in leading Phase I-IV ... Clinical Project Manager responsible for overseeing the planning, execution, and management of clinical trials across multiple phases. This role ensures compliance… more
- Anavex Life Sciences Corp. (New York, NY)
- …previous PV experience 5 to 10 years' related experience in a biotechnology or pharmaceutical company or CRO environment 5 to 8 years' experience in ... monitoring, and prevention of adverse events and effects with pharmaceutical products. The role requires a careful and precision-based...leadership team to set up, select and onboard PV vendor/ CRO and maintain an efficient PV system in compliance… more
- Medpace, Inc. (Irving, TX)
- …and / or statistical programming experience; Knowledge of databases and data management process; and Knowledge of statistical methods commonly used in ... pharmaceutical clinical trials. Travel: Minimal Medpace Overview Medpace is...Overview Medpace is a full-service clinical contract research organization ( CRO ). We provide Phase I-IV clinical development services to… more
- AbbVie (Lake Forest, IL)
- …technical guidance for team members, performs ongoing and annual performance management and staff career development, initiate and lead stat programming related ... process improvement collaborating with CRO partners, create a collaborative team work environment for...partners, build strong relationship with internal and external stakeholders management . This person may also need to support clinical… more
- Medpace, Inc. (Cincinnati, OH)
- …to be fully remote with the right experience**. Responsibilities Provide medical management and expertise for clinical trials; Contribute medical expertise to study ... studies and trials including feasibility assessments, design processes, educational efforts, management of medical information, and reviewing and editing of medical… more
- Planet Pharma (Plainsboro, NJ)
- …eCRFs completion guidelines, and provide scientific support for other key data management deliverables (eg database lock activities) - Lead the development of the ... coordination with Scientific Communications - Prepare presentations for Investigator meetings, CRO /CRA training, SIVs as warranted - Mentor junior level Clinical… more
- Genmab A/S (Princeton, NJ)
- …visits and ensure quality and compliance across all activities. Site Selection and Management Collaborate with the CRO and/or internal functions to oversee site ... review of country-specific informed consent forms with internal stakeholders Vendor Management and Oversight Monitor and manage vendor deliverables across trial… more
- Sirtex (Woburn, MA)
- …CROs, CDMOs, radiopharmacies, and hospitals. Coordinate project operations such as CRO registration, production scheduling, supply management , and logistics. ... into development strategies. Facilitate general business discussions and project management operations to align team efforts with corporate goals. Qualifications… more
- Takeda Pharmaceutical Company Limited (Cambridge, MA)
- …equivalent plus 7 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical ... in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company.… more
