- Tris Pharma (Monmouth Junction, NJ)
- …clinical trial result reportingLeads interactions with academic thought leaders, investigators and other clinical stakeholders; Represents Company and its programs ... Key Opinion Leaders (KOLs), scientific advisory boards and lead clinical investigators , among others Advises Senior Leadership on clinical development matters,… more
- Merck & Co. (North Wales, PA)
- …scientific findings, research methodologies-Identification of scientifically and operationally strong investigators who can assist in the development of our ... company's investigational and marketed drugs-Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the internal clinical study physicians and physician scientists as well as external investigators is expectedThe CS Group Lead will also ensure the writing of ... ethical and regulatory requirements across regions- Interact with clinical investigators , academic organizations, co-development partners, and strategic outsourcingCS Group… more
- Duke Health (Durham, NC)
- …clinical trials and optimize communication with patients, families and investigators regarding clinical trials, including personalized education for patients about ... clinical trials, build trusting relationships in relation to clinical trials, and support the patients in shared decision making regarding participation in clinical trials. Monitor identified patient population's participation in care (ie cancellations, no… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Signatures o 21 CFR 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators , Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human ... Subject Protection (January 2009) o FDA Guidance for Industry and Investigators - Safety-Reporting Requirements for INDs and BA/BE Studies (December 2012) o Japan… 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
- 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
