- Parexel (Indianapolis, IN)
- …is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study ... and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (eg enrollment, database release), to safeguard the… more
- Parexel (Indianapolis, IN)
- …is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study ... and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (eg enrollment, database release), to safeguard the… 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)
- …to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good ... issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local… more
- Parexel (Indianapolis, IN)
- …to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good ... issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local… more
- Parexel (Indianapolis, IN)
- …work remotely. The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person ... attitude + Attention to detail + Thorough understanding of statistical issues in clinical trials + Ability to clearly describe advanced statistical techniques… more
- Parexel (Indianapolis, IN)
- …you'll leverage your medical expertise to ensure the safety of patients in clinical trials and post-marketing settings. In this pivotal role, you'll perform ... limited to (including complex and challenging cases requiring expert judgement)), clinical trial , and literature cases including combination products… 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)
- …(affiliates, Product Development, commercial, etc.). + Plan and conduct statistical analyses of clinical trials and other relevant data sources and develop ... client solutions across multiple projects-leveraging competencies in **statistical theory, data analysis and interpretation, regression analysis, systematic review, and… 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)
- …channel strategy, and preparation of final reports and publications. + Participate in reporting of clinical trial data in Clinical Trial Registry ... of responsibility, the development, conduct and reporting of local clinical trials ; the implementation of global ...I and II studies where applicable), as well as non- clinical trial solutions/activities that are conducted in… more
- Lilly (Indianapolis, IN)
- …of external health care professionals according to guidelines above. + Participate in reporting of clinical trial data in Clinical Trial Registry ... gastroenterology therapeutic area will support early and late phase clinical trials for assets in the gastroenterology...clinical data relevant to the molecule. Clinical Research/ Trial / Execution and Support + Plans,… 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
- Merck (Indianapolis, IN)
- …with respect to digital data management (ie use of novel technology within clinical trials ). + The CQOM will build and enable effective working relationships ... Clinical Research, Clinical Site Management, Clinical Trial Management Processes, Clinical Trials , Conflict Resolution, Decision Making,… more
- Merck (Indianapolis, IN)
- … Development, Clinical Research, Clinical Site Management, Clinical Trial Management Processes, Clinical Trials , Clinical Trials ... Clinical Research Managers (CRMs), in the Global Clinical Trial Operations (GCTO) Regions in alignment...**Required Skills:** Accountability, Accountability, Adaptability, Business Processes, Clinical Data Management, Clinical… 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)
- … 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)
- …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
- Lilly (Indianapolis, IN)
- …+ Leverage robust knowledge of multiple inventory methodologies to collaborate with Clinical Trial Study Management and facilitate optimal Supply Planning. + ... + Maintain GMP/GCP compliance by following procedures applicable to clinical trial execution. + Actively participate in...+ Provide ongoing support and maintenance for all Lilly clinical trials utilizing IWRS. + Provide consultation… more
- Lilly (Indianapolis, IN)
- … data safety monitoring boards, medical monitoring) + Reviews and evaluates emerging clinical trial data and oversees data interpretation; supports ... registry trials / studies) + Supports the clinical operations team, including clinical trial...(eg, slide decks, posters, manuscripts, abstracts, etc.) based on clinical trial data + Supports… more
