- IQVIA (Durham, NC)
- The Associate Clinical Project Manager /Local Trial Manager is a member of the core project team responsible for project delivery of clinical studies ... the Project Lead for partnering in overall project management, Clinical Lead for site management, the Project Management Analyst...coordination, tracking and financial analysis, and the Site Activation Manager as an expert in start-up. This is an… more
- Bausch + Lomb (Raleigh, NC)
- …informed consent form (ICF) development, site selection and communication with clinical trial sites regarding all logistics including contract agreements, ... clinical investigations and post-market studies. + Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical… more
- Actalent (Raleigh, NC)
- Remote Sr. Manager - Clinical Quality Management The Sr. ..., Clinical Quality Management for the RWE Clinical Trial business will be responsible for ... of the quality activities for the broader business and clinical trial site level to ensure the...continuous improvements. + Ensure Standard Operating Procedures (SOPs) and Internal Operating Procedures are reviewed periodically and advise on… more
- IQVIA (Durham, NC)
- …our 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
- Actalent (Raleigh, NC)
- Clinical Trials Project Manager Lead and...Sponsor and other functional team members for the assigned clinical trial project MUST have CRO ... existing business processes + Understands and maintains compliance with internal and external privacy and legal + Manage the...a minimum of 5 years of experience as a Clinical Project Management or Clinical Trial… more
- Actalent (Raleigh, NC)
- …biopharmaceutical companies, including participating in pre-sales, contracting, and ensuring the clinical trial meets contractual requirements in accordance with ... Clinical Trials Project Manager The ...Sponsor and other functional team members for the assigned clinical trial project. * Participate in bid… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …of oncology clinical trials. This position provides expert level knowledge in clinical trial practices and regulations. This position works under the direct ... staff and external agencies/organizations. Education and Experience: Therapeutic clinical trial coordination experience involving drugs and/or devices,… more
- J&J Family of Companies (Raleigh, NC)
- …needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation ... Johnson & Johnson, we all belong. Reporting to the manager of clinical research associates, the person...parameters of study hypothesis, as well as to monitor clinical trial /study safety, in keeping with protocols,… more
- North Carolina State University (Raleigh, NC)
- …of new and existing clinical trials and research initiatives, and oversee clinical trial activities. These duties include, but are not limited to, ... who have experienced trauma. The Institute for Trauma Recovery invites applications for a Clinical Research Manager to help advance this mission. The Clinical… more
- United Therapeutics (Durham, NC)
- …reports); Oversee database generation and production of tables and listings; Ensure clinical trial material (CTM) is available for sites and/or Contract ... + Demonstrated understanding of the overall drug development process with clinical trial design, study implementation, sponsor/site interactions, scientific and… more
- Edwards Lifesciences (Raleigh, NC)
- …the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA submission experience + The ... and be part of our inspiring journey. As **Senior Manager , Biostatistics** , you are responsible for leading a...+ Act as core team member/lead biostatistician of assigned clinical trial (s) in US and international/global … 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 ... your future at Takeda. Join us as the Senior Manager , Innovation and Change Management based remotely reporting to...of one or multiple projects in support of the clinical trial delivery operating model. This will… more
- UNC Health Care (Chapel Hill, NC)
- …infusions, blood product administration, Bone Marrow Transplant patient care, clinical trial administration and monitoring, and urgent care ... care consistent with professional standards. Reporting and accountable to the Nurse Manager /Director, the Clinical Nurse is responsible for coordinating and… 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
- IQVIA (Durham, NC)
- …with a global view, this Center of Excellence is a chance to revolutionize the clinical research industry. **Senior Product Manager - The Role** In the role of ... COE) harnesses our global healthcare insights, working closely with our clinical and therapeutic experts to power evidence-driven design, speed site activation… more
- IQVIA (Durham, NC)
- …with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol, customer requirements, and internal ... related issues where required. * Collaborate with key stakeholders both internal and external, through effective communication and resolution management, including… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- …above Required Skills: + Excellent verbal, written, and interpersonal skills + Knowledge of clinical trial study design + Able to work independently on multiple, ... Position Description: As the Manager of Statistical Programming you would provide daily...data + Facilitate advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate,… more
- IQVIA (Durham, NC)
- …change and ambiguity + Ability to work on multiple projects + Knowledge of clinical trial environment and drug development process advantageous + Good technology ... and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as...individual sites + Distribute completed documents to sites and internal project team members + Update and maintain … more
- IQVIA (Durham, NC)
- …ambiguity + Ability to work on multiple projects + General awareness of clinical trial environment and drug development process advantageous + Good technology ... regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary + Review… more