- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position The Deviation Investigator -Writer is responsible for investigating and writing of deviations to the ... merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations and writing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials, Managed Access programs and Collaborative Research to the ... support to uphold the ethical conduct of interventional, non-interventional, investigator -initiated trials, Managed Access programs and Collaborative Research to the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.Note that vendor management is not limited to the ... bring deviations to the supervisor. Review and approve Vendor invoices, including investigator grants and pass-through costs.Provide oversight of the CRO to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator 's Brochure (IB), integrated safety summaries, abstracts and planned publications ... by participation in project/trial groups/teams established, as appropriate and conducts Investigator training as required Provide answers to enquiries from HAs and… more
- Insmed Incorporated (San Diego, CA)
- …projects.Manage and participate in developing and drafting protocols, forms, investigator brochures, clinical study reports and other documents as needed.Manage ... appropriate metrics to assess performance, compliance and cost effectiveness.Leads investigator meetings, kick-off meetings, monitoring training and various CRO (or… more
- Merck & Co. (North Wales, PA)
- …for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The Regional Medical Scientific Director serves ... the comprehension of the scientific foundations and goals of investigator -sponsored researchIdentifies barriers to patient enrollment and retention efforts to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.Support Fair Market Value process in evaluating study budgetsCollect ... to supervisor's attention.Track study metrics such as site start-up, Investigator /site performance, recruitment, regulatory documents, TMF filing and QC activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.Ensure study budget is reconciled with Finance ... including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is not limited… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.Ensure study budget is reconciled with Finance ... including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is not limited… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management preferably with a sponsor company at a global level. Prior investigator site and/or monitoring experience is advantageousProven track record of providing ... feasibility related services and value to organization(s)Demonstrated success in working cross-functionallyTravel: Ability to travel up to 10% Remote by Design. May require some travel (domestic or global)Daiichi Sankyo, Inc. is an equal… more
- Merck & Co. (Rahway, NJ)
- …trials run in-house, 400+ outsourced or run by partners, and 300+ company Investigator Initiated Studies (IIS) clinical trials. GCS is accountable for the planning, ... sourcing, labeling, packaging, and delivery of clinical supplies to clinical sites across more than 60+ countries, in accordance with US and Global regulations, company policies, and Standard Operating Procedures. --Your Fellowship Project--Ensuring treatment… more
- Aequor (Athens, GA)
- …collection pre- and post-mortem in accordance with study protocols and direction of Investigator or delegate. Sample types may include but are not limited to blood, ... feces, oral fluids, nasal, tonsillar, or laryngeal swabs, tissues, etc. Assists with necropsies at direction of Site Veterinarian or delegate. Physical Demands / Surroundings - This position requires the ability to work in extreme environments (hot, cold,… more
- Catalent (Philadelphia, PA)
- …"Good Manufacturing Practices" and "Good Distribution Practices"Act as lead investigator for all compliance issues regarding incoming, distribution, returns, ... destruction, or packaging/productionDevelop process excellence and efficiencies prior to the beginning of a project; Track and report metrics and identify trends and predictive modelsReview and revise SOPs/Forms, Distribution Summaries/Checklists, and Returns… more
- BioAgilytix (Durham, NC)
- …needs based on projected project needsMay serve as principal investigator on a projectMay prepare and submit deviationsManage project timelines/schedulingManage ... budget and revenue for projectsCommunicate with clientTrain analysts/junior scientistsDevelop assay independentlyAbility to assist with definition of project scope and proposal preparation (SME)Prepare and review scientific training materialsSet up studies in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and supervise the deviation investigation team, assign deviations based on investigator skill/experience and deviation type, ensure level-loading of investigator ... workload, and identify and support training and development opportunities to advance investigators' skillsets. Mentor and coach investigators Identify and deploy advanced investigational techniques to support more effective investigations and identification of… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …a variety of animal models of disease; and may serve as the principal investigator or study director on a variety of sponsored programs; supervise and oversee the ... of disease models and safety/efficacy studies; support and develop investigator -initiated sponsored research programs; and perform all other related duties… more
- Merck & Co. (Rahway, NJ)
- …trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update ... reports, study close out activities).- Leads team for timeline management, risk identification and mitigation, issue resolution.- May facilitate and collaborate with key internal/external stakeholders (eg, study team, country teams, vendors, committees) in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documentsAuthors or oversees the development of safety sections of Investigator 's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data ... Sheet (CCDS), Risk Management Plan(s) (RMPs)Collaborates with PSL(s) and cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communicationEnsures consistent and unified safety message throughout multiple… more
- Taiho Oncology (TX)
- …In collaboration with Medical Affairs personnel support data generation Investigator -Initiated Trials (IITs) and HCP initiated projects. Facilitate the review ... and follow-up of submitted IITs. Assist with Taiho sponsored trials as assigned, which may include providing recommendations for site selection, clinical data presentation at site initiation or training meetings, and communication of scientific insights for… more
- Merck & Co. (North Wales, PA)
- …country-specific data supporting pricing and reimbursement Work with our company's Investigator Study Program Committee to evaluate outcomes research study protocols ... for studies in local markets Support our Manufacturing Division's affiliates to understand local needs, adapt health economic evaluations, customize Outcomes Research documents such as protocols and reimbursement dossier, which includes the development of the… more
