- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Recursion (New York, NY)
- …diverse data sets, and sophisticated analytics. We are seeking an Associate Director, Clinical Data Management who can lead and oversee end to end ... Clinical Data Management activities on assigned studies...Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data -related deliverables.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data ... the function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions...thinking for outsourcing strategy. As a member of the CRO governance committee, provides strategic leadership in Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to determine risk factors with and for other technical departments (eg, Clinical , Medical, Safety, Data Management, Statistics). This position requires skills ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… more
- Eisai, Inc (Nutley, NJ)
- …strategies.Experience in managing and directing related functions such as data management, CRO vendor management, procurement, and contracting.Excellent ... your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …case review, documentation reviews in collaboration with the ICSR management and CRO /Vendor oversight groups for case processing activities and reports to the ... matter expert in ICSR standards, decision making and trouble shooting. Identifies CRO /vendor training as needed. Reviews overall processes and identifies areas of… more
- Lifelancer (Boston, MA)
- …monitoring from site qualification to site closure visits to assure integrity of clinical data with respect to accuracy, accountability and documentation through ... source documents, and medical records. Support the review/cleaning and reconciliation of all clinical data , including EDC, PROs, and 3rd party labs to support… more
- REGENXBIO (Rockville, MD)
- …of data management and clinical operations teams in review of clinical data ; provides guidance on issues and queries as needed and implements risk ... Responsible for the selection and oversight a study specific and GCP training of CRO study staff, clinical monitors, investigational sites and vendors Manages … more
- Arcellx (Redwood City, CA)
- …staff training and quality assurance (QA) purposes. Review the quality and integrity of the clinical data through review of electronic CRF data . Skills and ... Who We Are Arcellx isa public, clinical -stage biotechnology company reimagining cell therapy by engineering...quality, timelines, and budget with the internal functional leads, CRO , and vendors to ensure overall project objectives are… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …and validation partnering with Translational Sciences colleagues when applicable Manages clinical biomarker data delivery and analysis and associated timelines ... of the Global Research organization in BMS and leads late stage clinical , pharmacological and translational research and development activities for the pipeline and… more
- MMS Holdings Inc. (Canton, MI)
- …where you'll be part of a supportive, innovative team? MMS is a award-winning, data -focused clinical research organization ( CRO ). We pride ourselves on being ... skills. Good organizational and communication skills. Basic understanding of CROs and scientific and clinical data /terminology, and the drug development process. more
- Actalent (Pennington, NJ)
- …and study coordinators. Facilitate collaboration among cross-functional teams including Clinical Operations, Data Management, Medical Writing, Quality Assurance, ... and other departments. Ensure high-quality data collection and adherence to data integrity...clinical trial management within the pharmaceutical, biotech, or CRO industry. Proven experience in leading Phase I-IV … more
- PTC Therapeutics (Warren, NJ)
- …programs in the assigned therapeutic areas. Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; develops ... database systems. Working knowledge of R. Expertise in the implementation of Clinical Data Interchange Standards Consortium (CDISC) standards. Applied knowledge… more
- Recursion (New York, NY)
- …and involvement with invoice and contract review and approvals Experience working closely with data management and clinical teams to set up study systems and ... the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a...We are seeking a highly motivated and skilled Senior Clinical Project Manager within our Clinical Operations… more
- Exelixis (Alameda, CA)
- …in the conduct of clinical trials. Experience with statistical applications and clinical data management procedures in the conduct of clinical trials. ... Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings. Knowledge/Skills: Knowledge of appropriate… more
- AbbVie (Lake Forest, IL)
- …Director, Statistical Programming leads the whole stat programming team within CDOR ( Clinical Data Operation and Reporting) in OED (Oncology Early Development) ... clinical development organization.The stat programming team performs statistical programming...and lead stat programming related process improvement collaborating with CRO partners, create a collaborative team work environment for… more
- University of Kansas Medical Center (Kansas City, KS)
- …followed and maintained. Along with the QA team, the QA Manager provides quality control support, assistance and direction for clinical trials supported by KUCC ... accordance with Institutional and Regulatory guidelines; therefore, achieving quality and efficacious data and positive clinical outcome with the ultimate goal… more
- Planet Pharma (Plainsboro, NJ)
- …the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various ... stages of clinical development (eg clinical trial implementation), and...completion guidelines, and provide scientific support for other key data management deliverables (eg database lock activities) - Lead… more
- Aditum Bio (Cambridge, MA)
- …or health related field. Advance degree preferred. Minimum 10 years experience biotech/pharma/ CRO clinical trials experience with at least 6 years hands-on ... of concept. The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to… more
- Boston Scientific (Marlborough, MA)
- …papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice. Efforts ... clinical studies. May lead studies executed by a CRO . Provides clinical input for new product...with Regulatory Affairs during the submission process. Presents scientific data by communicating accurate, succinct summaries of clinical… more
