and global clinical trial regulations (e.g., ICH, CFR, EU Clinical Trial Regulation). Hands-on experience supporting regulatory... inspections and audits. Proven experience conducting investigations and managing CAPAs. Knowledge of clinical trial systems...
, and cost Responsible for co-leading the clinical trial budget estimation & validation processes with the clinical operations... underserved therapeutic areas and make patients the focus of every strategic decision. Role Summary The Manager, Strategic...
, and statistical instructions. Develops and/or validates SAS programs to generate statistical output (e.g. TLFs) of clinical trial... Contract Research Organizations (CROs). Develops and tests SAS codes for clinical trial database logic checks. Assign tasks...
of scientific data through publications, presentations, and educational materials. Guide clinical trial strategy, investigator... plans with corporate goals, regulatory requirements, and evolving market needs. Scientific and Clinical Expertise Provide...
strategies as defined by regulatory leadership to support clinical trial initiation and advancement. Cross-functional...+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related...
is designated as the nursing leader during a specified tour of duty on a clinical bed service unit. The incumbent has the overall... with charge nurse/manager. Foster mutual sharing of information and maintains communication between health care team...
and intervention outcomes per hospital policy Monitor and report changes in patient condition to Nurse Manager and charge nurse... and data collection Applies evidence-based practices to clinical care Demonstrates empathy and compassion in patient...
, and generating key documents such as statistical analysis plans and grant materials for both observational studies and clinical... all phases of research projects including clinical trials. Functions as a study Lead Statistician and is accountable for study...
, compliance with regulatory standards and efficient execution of programming deliverables, contribute to clinical development... in a team setting and focus on business priorities Collaborate with cross-functional team on clinical study planning...
progress to ensure established benchmarks are met. Communicate and collaborate with clinical trial key stakeholders through... of current regulations, regulatory guidance and or local policies. Assists Clinical research Manager with regulatory based...
and auditing visits with study coordinator, Investigator, DF/HCC QACT, Industry Sponsors, and third party auditors. Clinical Trial... to ensure established benchmarks are met. Communicate and collaborate with clinical trial key stakeholders through the start-up...
the negotiation of Subcontracts, Clinical Trial Agreements, Data Use Agreements, Billing Agreements, and other atypical... Clinical Trials Office, the Technology Ventures Office, Institutional Review Board, and other institutional offices to oversee...
and auditing visits with study coordinator, Investigator, DF/HCC QACT, Industry Sponsors, and third party auditors. Clinical Trial... to ensure established benchmarks are met. Communicate and collaborate with clinical trial key stakeholders through the start-up...
supervision of the clinician and reporting directly to the Practice Manager, the Gap Intern shall provide direct and indirect care... for Scribing/Documenting office visit on computer for clinician. Responsible for cross coverage when needed. May assist clinical...
clinical trial materials and commercial products to ensure a global Quality strategy is developed and maintained... is accountable for end-to-end quality oversight of Biologics and Combination Device program(s) throughout clinical development...
analysis to clinical trial implementation and closeout. The Per Diem Mobile Research Nurse is a Registered Nurse who..., if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care...
progress to ensure established benchmarks are met. Communicate and collaborate with clinical trial key stakeholders through... of current regulations, regulatory guidance and or local policies. Assists Clinical research Manager with regulatory based...
supervision of the clinician and reporting directly to the Practice Manager, the Gap Intern shall provide direct and indirect care... for Scribing/Documenting office visit on computer for clinician. Responsible for cross coverage when needed. May assist clinical...