- Lilly (Indianapolis, IN)
- …wage for this position is $63,000 - $140,800 **Purpose:** The Clinical Development Trial Leader (CDTL) Associate leads the cross-functional study team ... The CDTL Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Purpose** : The Associate Director - Clinical Trial Foundations (CTF), will ... serve as the subject matter expert for clinical systems supporting clinical development ....primarily focused on EDC and data aggregation systems. The Associate Director is responsible for collaborating with business partners… more
- Lilly (Indianapolis, IN)
- …innovative and reliable systems, processes, and information to enable clinical development and speed medicines to patients. The Associate Director CTF ... Purpose: Trial Management Systems as part of Clinical Trial Foundations (CTF), within Clinical... Management Systems will support operational and innovative system development to drive the implementation of robust functionality within… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …with the development of new and effective strategies to diversify clinical trial populations that are reflective of the anticipated treatment populations. ... of diversity and inclusion strategy and tactics for global clinical trial programs. + Accountable for the...directing delivery of quality pilot programs, and business case development for broader adoption of diversity and inclusion strategies.… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …management related to quality events and internal audits for clinical trial delivery functions including the identification and development of applicable ... and tools + Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA/EC-related… more
- Lilly (Indianapolis, IN)
- …internal and external data (eg, prevalence data, real world data and analytics, clinical trial enrollment data) analyses and insights to develop and advise ... is $111,000 - $178,200 **Purpose:** The purpose of the Associate Director Informaticist role is to support the design...ensure completion of modeling and scenario needs by applying clinical development , TA, and analytics expertise +… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. CDCS leads the integration of collected ... and empower you to shine? Join us as an Associate Director, Data Configuration Engineer in our Cambridge, MA...products. Further, CDCS efforts enable valid secondary use of clinical trial data throughout Takeda research groups… more
- Astrix Technology (Indianapolis, IN)
- …space. + Working knowledge of Clinical & Regulatory systems such as Clinical Trial Management System (CTMS), electronic Trial Master Files (eTMF), ... for the sale and growth of Astrix Technology Group's Clinical and Regulatory Consulting services to a portfolio of...of 80 % of their time in new business development . + Demonstrate business development outreach through… more
- Merck (Indianapolis, IN)
- …the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects ... Responsibilities:** + Serving as an expert representative for QP2-IO on Oncology clinical development teams. + Framing critical questions for optimizing… more
- Lilly (Indianapolis, IN)
- …create investigational product label text that meets the needs of a given Clinical Trial study and is compliant with all applicable regulatory requirements. ... Planning, Label Project Coordinators, Local Data Analysts, Packaging Operations, Clinical Development Organization, third parties, global affiliates, Quality,… more
- Community Health Network (Indianapolis, IN)
- …investigators in identifying, screening, interviewing, and consenting eligible patients for the clinical trial and completing the associated data entry and ... The Clinical Research Specialist will be responsible for the development and implementation of recruitment strategies and plans for enrolling clinical… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …clinical study management/oversight, including significant study management support experience (eg clinical trial assistant/ associate or lead CRA). + ... studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical… more
- Merck (Indianapolis, IN)
- …and retention efforts to achieve study milestones + Upon request from Global Clinical Trial Operations (GCTO), + Recommends study sites and identifies potential ... **Role Summary** + The Oncology Regional Medical Scientific Director ( Associate RMSD) is a credentialed (ie, PhD, PharmD, DNP,...investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits… more
- Lilly (Indianapolis, IN)
- …4. Scientific data dissemination and exchange * Oversight of timely dissemination of clinical trial data. * Oversight of the critical analysis of data ... contribution to clinical trials and communicates research needs to global Development team, Health Outcomes and Pricing, Reimbursement & Access (PRA) teams to… more
- Bristol Myers Squibb (Indianapolis, IN)
- …of Isotopes and the RayzeBio pipeline of radiopharmaceutical drug products for global clinical trial and commercial use. This role will partner with external ... teams + Proven expertise in GMP operations and compliance for global clinical trial and commercial injectable or radiopharmaceutical operations required. +… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …and maintain DMC/IRC R&D wide communication strategy. + Partner with Global Clinical Development Operations Process Excellence and Delivery team to determine ... industry, or related field required. + Experience influencing senior-level management, with clinical trial background preferred and key stakeholders is a plus.… more
- Lilly (Indianapolis, IN)
- …maintained that monitors global Lilly operations and Collaboration Partners in support of Clinical Trial supply. It ensures that operations are performed in ... (GQAAC) division and represents the Global Quality Auditing interface for the development organization. The position assures that an effective audit program is… more
- Lilly (Indianapolis, IN)
- …use for internal and external manufacturing, as well as occasional FTZ support for clinical trial development . + **FTZ Structure Establishment:** Lead the ... establishment of new FTZ structures and zones at five new manufacturing sites. + **Stakeholder Collaboration:** Partner with external consultants and internal collaborators, including Manufacturing Strategy, Supply Chain, Finance, Procurement, Tax, and Legal,… more
- Edwards Lifesciences (Indianapolis, IN)
- …the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA submission experience + The ... will make an impact:** + Act as core team member/lead biostatistician of assigned clinical trial (s) in US and international/global trial + Accountable for… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …achieved. + Perform negotiation and administration of global master clinical trial agreements rate cards. + Support the development of creative processes, ... Senior Site Budgeting Analyst based remotely, reporting to the Associate Director, Site Budgeting and Contracting. At Takeda, we...study. + Negotiate directly with globally assigned sites master clinical trial agreements rate cards. + Support… more