Medicine Biomarker team at Clinical trial study teams (CST) and Biomarker/OTM Matrix teams. As part of the CST, establishing... of contact for resolving study biomarker issues. Collaborate with clinical operations and sample management to ensure biomarker...
(for an indication or for multiple studies within an indication) from study start up through to regulatory submission. In collaboration... with cross-functional teams, external partners, and support Data Managers, may serve as the lead study data manager for a large...
. Serve as the point of escalation for the COMs for issues that can’t be resolved at the study level. Collaborate with COMs...+ years’ experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study...
of clinical study designs, analysis methodology and data interpretation. Advanced knowledge of pharmaceutical industry, overall... and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the...
this expertise to enable very complex study designs driven by advanced randomization schemes, complex sourcing strategies, automated... inventory methodologies, and data flow requirements. Key Responsibilities: Study Setup process management and oversight...
development and drug safety systems Work with contract auditors and CQA management to develop study specific audit plans Review... by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification...
. Demonstrated independent analytical and problem-solving abilities. Full understanding of regulatory requirements of study types... or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states...
resource within own discipline or as technical functional teams or projects. Ensure all study management activities... will be completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP; audit leadership- interviewee & responses...
SUMMARY/JOB PURPOSE: Leads statistical programming activities at the study or project level. Uses statistical... develop SAS or other programs, and specifications, for use in study or other analyses, such as Integrated Safety Summaries...
Manage and mentor junior staff, providing guidance in experimental design and overseeing/helping with study execution..., or any other characteristics protected under applicable federal, state and local laws. ImmunEdge will make reasonable accommodations for qualified...
for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports... as needed. Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams. Provides writing guidance...
Overview: The Director of Federal Aid (Associate Director in HR information system) reports to the Executive Director..., customer service, willingness to learn and acquire new skills, and commitment to deadlines. Responsibilities: The Director...
Overview The Director of Federal Aid (Associate Director in HR information system) reports to the Executive Director..., customer service, willingness to learn and acquire new skills, and commitment to deadlines. Responsibilities The Director...
is meaningful and contributes to our mission of redefining the possible in healthcare. The Director is responsible for day to day... Education Education Level Preferred Area of Study Bachelors Degree or Equivalent Experience Business Other Preferred...
is meaningful and contributes to our mission of redefining the possible in healthcare. The Director is responsible for day to day... Education Education Level Preferred Area of Study Bachelors Degree or Equivalent Experience Business Other Preferred...
is meaningful and contributes to our mission of redefining the possible in healthcare. The Director is responsible for day to day... Education Education Level Preferred Area of Study Bachelors Degree or Equivalent Experience Business Other Preferred...
is meaningful and contributes to our mission of redefining the possible in healthcare. The Director is responsible for day to day... Education Education Level Preferred Area of Study Bachelors Degree or Equivalent Experience Business Other Preferred...
. Join Gilead and help create possible, together. Job Description We are looking for an Associate Director, Clinical... cross-functional study team. With input from others, designs clinical pharmacology study protocols, study data analysis...
Job Description: Certified Dietary Director Are you a Dietary Director seeking an exciting new career opportunity... and compassionate, WE WANT YOU! What Will You Do in This Role? As a Dietary Director, you will be responsible for planning...
agency that empowers New Yorkers to have a greater impact on their elections. Our mission is to make local democracy..., increasing transparency and accountability in local government. We believe that when every New Yorker is empowered...