- Merus (Cambridge, MA)
- Clinical Trial Associate /Senior Clinical Trial Associate Department: Clinical Operations Employment Type: Full Time Location: Cambridge, MA ... Description The Clinical Trial Assistant (CTA) / Senior CTA plays a vital role in supporting the planning, execution, and documentation of clinical trials in… more
- Dyne Therapeutics (Waltham, MA)
- …more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. Role Summary: The Clinical Trial Associate (CTA) provides Clinical Operations ... of relevant hands-on drug development experience in Sponsor setting Knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory… more
- Merck & Co. (Rahway, NJ)
- … supply chain across the full Company's Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...packaging and delivery of clinical supplies to clinical sites globally. The… more
- Merck & Co. (North Wales, PA)
- …Documentation, Clinical Investigations, Clinical Judgment, Clinical Reporting, Clinical Research, Clinical Trial Documentation, Clinical ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and… more
- Merck & Co. (North Wales, PA)
- …or related field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... related field plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Merck & Co. (North Wales, PA)
- …trials.Job ResponsibilitiesResponsible for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical Trial ... (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management… more
- Merck & Co. (South San Francisco, CA)
- …Develop model-based strategies ( translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within ... all phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. Represent QP2 on cardiometabolic and… more
- Genmab (NJ)
- …synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners ... trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal detection and characterization for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert consultant ... direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring… more
- Merck & Co. (San Francisco, CA)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas....seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions… more
- Merck & Co. (San Francisco, CA)
- …Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills:Budget Development, Business, Clinical Supply Chain Management, Clinical ... Job Description Position Description: Associate Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS)… more
- Insmed Incorporated (Los Angeles, CA)
- …strong related experience.Other Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management/ trial experience and 2 years clinical ... Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director Medical Science Liaison will develop and maintain professional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after… more
- Formation Bio (New York, NY)
- …in program execution, ensuring the team stays at the forefront of innovation in clinical trial operations. About You You're excited about the intersection of AI ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Merck & Co. (North Wales, PA)
- …or related field plus at least 7 years SAS programming experience in a clinical trial environment OR a Bachelor's degree in Computer Science, Statistics, Applied ... or related field plus 9 years SAS programming experience in a clinical trial environment. Required Skills and Experience: Experience in CDISC SDTM and ADaM… more
- Eisai, Inc (Nutley, NJ)
- …and soft-skills training (eg medical insights workshops, presentation skills, understanding clinical trial design, statistics, etc.) to supplement MSL ... difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Merck & Co. (North Wales, PA)
- …decision-making skills, expertise in leading large teams in the development of novel clinical trial designs and analysis methods in oncology, experience in ... including regulatory submissionsDemonstrated history of development and execution of innovative clinical trial designs and exploration of novel analysis methods… more
- Aequor (Thousand Oaks, CA)
- …the design and implementation of both new technologies, new processes.Job Description: Clinical Trial Delivery Operating Model: Develop Data Management playbook ... efficiencies and reduce hand offs. Collaborate with cross-functional teams ( clinical operations, site management, biostatistics, stats programming, TA) to optimize… more
