- J&J Family of Companies (Raleigh, NC)
- …* Create, populate, review, approve, distribute, and track study materials as assigned by the Clinical Project Manager and Clinical Program Manager . ... position requires a thorough understanding of clinical trials , including how to support a trial ...activation. A CTC II will work closely with the clinical project team to collect all essential… more
- Bausch + Lomb (Raleigh, NC)
- …Activities/Responsibilities:** + Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: ... consent form (ICF) development, site selection and communication with clinical trial sites regarding all logistics including...+ Provides clinical oversight and management for clinical trials to facilitate compliance with FDA… more
- IQVIA (Durham, NC)
- … Clinical Trials Regulatory Management department. **RESPONSIBILITIES** + Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical ... au niveau mondial Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …conducting, and supporting these trials across NC and the US. This Senior Project Manager position will oversee activation of UNC LCCC treatment clinical ... Cancer Center ( LCCC ) oversees and coordinates oncology clinical trial research for the UNC School...and Experience: ACRP -PM or PMI certification preferred. Oncology clinical trials or project management… more
- North Carolina State University (Raleigh, NC)
- …and existing clinical trials and research initiatives, and oversee clinical trial activities. These duties include, but are not limited to, contributing ... The Institute for Trauma Recovery invites applications for a Clinical Research Manager to help advance this...study teams + Organization, preparation, & ongoing management of clinical trials teams + Responsible for the… more
- American Heart Association (Durham, NC)
- …this role, you will be responsible for developing and implementing an accessible clinical trial database design by analyzing data inquiry needs, ensuring ... (including real world data) from multiple American Heart Association clinical trials , research studies and registries as...Provide or facilitate training on use of claims and/or clinical trial data as needed through group… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- …to: + Travels up to 80% within an assigned territory, monitors clinical trials according to monitoring plans to achieve project goals; conducts or assists ... Senior Clinical Research Associate, you will monitor clinical trial programs and manage regional ...regulations and guidelines. + Collaborates closely with the Study Manager and Project Manager . +… more
- United Therapeutics (Durham, NC)
- … trial design, study implementation, sponsor/site interactions, scientific and clinical methodology, protocol design, project management and regulatory ... approval for five medicines, we are always conducting new clinical trials , and we are working to...database generation and production of tables and listings; Ensure clinical trial material (CTM) is available for… more
- Edwards Lifesciences (Raleigh, NC)
- …biostatistician of assigned clinical trial (s) in US and international/global trial + Accountable for clinical trials assigned to direct reports ... Biostatistics, or related field with previous analytical experience in clinical trials with skill levels exceeding the...the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …technology for the implementation, optimization and maintenance of Takeda's clinical trial delivery operating model. The Senior Manager will contribute to ... for the project and track outcomes. + Contribute to maximizing clinical trial delivery process efficiency and regulatory compliance by identifying… more
- Cardinal Health (Raleigh, NC)
- …team is passionate about helping oncology practices navigate the future. The Clinical Programs Manager , Navista, executes innovative strategies for programs and ... solutions to enhance Cardinal Health's clinician facing business. The Clinical Programs Manager manages the research, business cases, development, and launches… more
- Medtronic (Raleigh, NC)
- …in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials + Proficient in MS Office applications: Excel, PowerPoint, Word, ... including TMVR or LAAC or other adjacent therapies + Clinical Research experience including coordinating multi-center trials ...MS Project (or similar scheduling software), project management… more
- United Therapeutics (Durham, NC)
- …we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials , and we are working to create an unlimited supply of ... pulmonary diseases, and other orphan diseases. **How you'll contribute** The Lead Project Manager , Manufacturing Business Operations plans and manages internal… more
- Humana (Raleigh, NC)
- …This individual remains continuously up-to-date with emerging therapies by analyzing news, clinical trials , analyst sales expectation, and other resources in ... caring community and help us put health first** The Clinical Pharmacy Lead - Pipeline monitors the drug development...and managing projects + Thrives in a fast paced, multi- project work environment while still ensuring attention to detail… more
- IQVIA (Durham, NC)
- **Job Overview** Join our team as a Clinical Research Site Manager , where you'll play a crucial role in ensuring our study sites operate seamlessly and adhere to ... selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. +… more
- Takeda Pharmaceuticals (Raleigh, NC)
- …startup forecasts are achieved. + Drive negotiation and administration of master clinical trial agreements. + Support the development of creative processes, ... and empower you to shine? Join us as a Manager , Site Budgeting and Contracting in Cambridge, MA or...**_CCOUNTABILITIES:_** + Manage negotiations, finalization and administration of Master Clinical Trial Agreements. + Responsible for assigned… more
- Institute for Medical Research (Durham, NC)
- …provide training and guidance to others in the clinic. + Prior experience with clinical research, clinical trials , FDA regulations, VA regulations, and HIPAA ... and improvement of research software Critical Element 2 - Supervise Clinical Research Coordinators, Regulatory Coordinators, Project Scientists, and/or Business… more
- Cardinal Health (Raleigh, NC)
- …Director) for a portfolio of products and/or services (ie Precision Medicine, Genomics, Clinical Trials Research, etc) During annual operating plan meetings and ... team is passionate about helping oncology practices navigate the future. The Clinical Programs Manager , Navista executes innovative strategies for programs,… more
- IQVIA (Durham, NC)
- …**Qualifications:** + Bachelor's degree + 8+ years' experience as a Scrum Master, Agile Project Manager , or Agile Delivery Manager with proven ability to ... and bring new medicines to patients faster through successful trial delivery. This multi-functional team is an innovation for...Center of Excellence is a chance to revolutionize the clinical research industry. **Agile Program Manager :** In… more
- IQVIA (Durham, NC)
- …and/or sponsor requirements. Essential Functions * Provides strategic planning and project oversight accelerating Site Activation through best in class project ... in accordance with the agreed start up strategy, adhering to agreed project timelines and in compliance with regulatory requirements (International Conference on… more