- Parexel (Indianapolis, IN)
- …and data flow - Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for ... working on phase I-IV global clinical trials - 2-3 years as a Clinical Trial Manager leading global clinical trials start up through close out -… more
- Parexel (Indianapolis, IN)
- …+ 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics ( clinical trial data and/or Real World Data ) + Medical ... affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology + Strong project management...techniques. + Experience in leading DM study teams, overseeing trial data activities, and collecting clinical… more
- Parexel (Indianapolis, IN)
- …how sample and testing data will be captured, blinded and transferred for clinical trials Human Sample Management Flow and Compliance + Provides guidance to ... managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to...and shipping of samples acquired in the course of clinical trials or other human sample acquisition… more
- Parexel (Indianapolis, IN)
- …following areas is required: samples, kits, data , and logistics operations for clinical trials . Understanding of one or more of the following is preferred: ... Lead cross-functional study teams, manage vendor relationships, and oversee clinical trial biosamples and data ...in academic, CRO, or pharmaceutical/biotech settings, with knowledge of clinical trials and clinical databases.… more
- Parexel (Indianapolis, IN)
- …key personnel to implement and operationalize Precision Medicine goals within client clinical trials . Manages central laboratory and specialty vendors on low ... to moderately complex clinical trials . Performs other duties as necessary.... Performs other duties as necessary to ensure optimal clinical trial execution. **Key Accountabilities** **:** **Study… more
- Parexel (Indianapolis, IN)
- …**RWE** Specialist join our team and support the design and execution of clinical trials through advanced analytics and evidence generation. Our team is ... + Focus on exploratory work to generate evidence supporting clinical trial design, including outcome summaries and...experience in pharmaceutical industry (eg Pharma, CRO, Biotech) and clinical trials . + Proficiency in SAS, R,… more
- Parexel (Indianapolis, IN)
- …studies, as applicable and/or appropriate for the MD + Providing risk assessment of clinical trials for local sponsorship as needed with the support of the ... conduct or protocol + Review and sign off all data listings / tables, protocol deviations, datasets, for medical...-Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical… more
- Parexel (Indianapolis, IN)
- …Sr Site Contract Leader is responsible for overseeing the site contracting process for clinical trials . The Site Contract Lead will manage the site contracting ... necessary support to cross-functional teams including Start up, Global Clinical Operations, Investigator Payments, Business Development and Feasibility + Provide… more
- Lilly (Indianapolis, IN)
- …position 3 days onsite/2 days remote **Purpose:** This role is responsible for trial level clinical data strategy including database structure, content ... with key study partners to define, implement, and deliver clinical data management packages. This role is... trial leadership and ownership for a particular trial , set of trials , or programs. **Primary… more
- Lilly (Indianapolis, IN)
- …of external health care professionals according to guidelines above. + Participate in reporting of clinical trial data in Clinical Trial Registry ... participates in: the development, conduct and reporting of corporate/global clinical trials in support of registration and...clinical data relevant to the molecule. Clinical Research/ Trial Execution and Support + Plans,… more
- Lilly (Indianapolis, IN)
- …trends in data entry + Develop metrics and ad-hoc reports for clinical trials + Analyze clinical data reports to determine points of interest + ... for people around the world. **Functional** **Overview & Responsibilities** ** Clinical Data Management Internship Overview:** Each intern...Overview:** Each intern may be assigned to an existing clinical trial to aid study teams in… more
- Lilly (Indianapolis, IN)
- … Study Build Programmer is responsible for leading and programming and testing clinical trial data collection databases, including the mapping, testing ... and associated data repository mappings for a trial or set of trials within a...a deep understanding of the technology used to collect clinical trial data + Effectively… more
- Lilly (Indianapolis, IN)
- … dissemination, and preparation of final reports and publications. + Participate in reporting of clinical trial data in Clinical Trial Registry ... activities over the entire spectrum of drug development and clinical trial phases. Specific activities include developing...area of responsibility, the development, conduct and reporting of clinical trials ; the implementation of global … more
- Lilly (Indianapolis, IN)
- …of external health care professionals according to guidelines above. + Participate in reporting of clinical trial data in Clinical Trial Registry ... clinical practices. She/He will conduct and support clinical trials in each phase of development....LRL priorities. + Understand and keep updated with the pre- clinical and clinical data relevant… more
- Merck (Indianapolis, IN)
- … Agreements (CTA), Clinical Trial Compliance, Clinical Trial Management, Clinical Trials , Contract Lifecycle Management (CLM), Contract ... a 24-36 month committed experience rotating throughout Research and Development Division/Global Clinical Trial Operations in various clinical trial… more
- Lilly (Indianapolis, IN)
- …▪ Bachelor's degree ideally in a scientific area ▪ Minimum 5 years of clinical trial data experience in drug development in areas intersecting ... technical experience and understanding of the data submission process in clinical data trials . + Experience with project management and leading without… more
- Lilly (Indianapolis, IN)
- …research. Your work or project may include but are not limited to the following: + Clinical Trial Planning and Design + Clinical Trial Investigator ... + Clinical Diagnostic and Laboratory Science + Clinical Statistics, Data Analysis & Data...Documentation + Clinical Supply and Delivery + Clinical Trial Budgeting and Financial Management +… more
- Sumitomo Pharma (Indianapolis, IN)
- …International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to ... SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that… more
- Lilly (Indianapolis, IN)
- …**Responsibilities:** + Be accountable for establishing, obtaining and exceeding goals for clinical trial initiation for development programs. + Lead team ... + 2+ years managing a team of direct reports + 5+ years in a Clinical Trial environment + Qualified candidates must be legally authorized to be employed… more
- Lilly (Indianapolis, IN)
- …Clinical Design Capabilities in the development of clinical plans and clinical trial designs (eg reference trials , design analytics, country ... focus and expertise. More about the role: **_Clinical Plan, Trial Options and Clinical Trial ...to deliver on new regulatory expectations (eg decentralization of clinical trials , increase racial and ethnic diversity… more
