- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV ... for clinical services, management of project timelines and deliverables. Key trial management support to the Associate Directors (CST Leads), as assigned.What… more
- Insmed Incorporated (NJ)
- …of clinical operations, project management, the drug development process, and clinical trial conduct, including systems and procedures, as well as the regulations ... and requirements governing such conduct (including, but not limited to, ICH / GCP and regulatory requirements).Experience managing staff and providing oversight of department activitiesEffectively oversees, manages, and influences CROs and third-party vendors… more
- Merck & Co. (Rahway, NJ)
- …external R& D collaborations to enable innovative strategies for clinical trial biomarker testing. Author and review internal technical reports including sections ... standards and guidelines pertaining to analytical method validation for clinical trial testing and FDA biomarker guidance Demonstrated experience with various NGS… more
- Genmab (NJ)
- …reduce site and patient burden while having a positive impact on overall trial timelines. Working closely with other Development Operations functions as well as ... Genmab, the Site Engagement Manager role will bring a high-touch and clinical trial 'face' with our sites.Additionally, the Manager may also support on-site and/or… more
- Merck & Co. (North Wales, PA)
- …for the formulation and execution of automation strategy in Global Clinical Trial Operations and all the support activities within their functional area. This ... includes working with stakeholders across Global Clinical Trial Operations (GCTO)and other relevant teams, driving the strategy from ideation to value realization.-… more
- Genmab (NJ)
- …would love to have you join us!Manager, Statistical ProgrammingHands-on support of clinical trial reporting; Leading a team of programmers to complete trial or ... Experience using SAS software packageOncology experience preferredPrevious experience as a trial lead preferredR experience a plusThis position does not have direct… more
- Genmab (NJ)
- …compound lead, primarily up until proof of concept, and/or as trial responsible statistician.ResponsibilitiesCompound/Indication LevelAct as lead and main point of ... courses and perform professional networkingEngage with regulatory authorities on trial level discussionsArranges/attends lessons learned to share learningsRepresents Genmab… more
- Formation Bio (New York, NY)
- …landscape contribute to therapeutic areas strategy Based on the clinical trial design landscape contribute to study design and planning strategy Operational ... Excellence: Drive/contribute to trial operations and medical processes to achieve continued innovation...continued innovation and improvement Utilize your clinical development and trial execution experience to develop creative ways to speed… more
- Merck & Co. (Rahway, NJ)
- …field plus 5-9 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... field plus 3-7 years SAS programming experience in a clinical trial environmentDepartment Required Skills and Experience:Effective interpersonal skills and ability… more
- Merck & Co. (Rahway, NJ)
- …field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and… more
- Merck & Co. (Rahway, NJ)
- …the GCS spokesperson at clinical development related meetings (ie, Clinical Trial Teams) and product-development related meetings. The incumbent must have ... are not limited to: Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates closely with other functional area representatives to… more
- Merck & Co. (Rahway, NJ)
- …activities include, but are not limited to: - Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives to ... Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) Regional colleagues and Global - Development Quality (GDQ) to… more
- Aequor (Sacramento, CA)
- …one or more Therapeutic or Technology Areas. Analyze and interpret clinical trial data, including efficacy and safety endpoints, and provide actionable insights to ... to identify trends, patterns, and potential safety signals in clinical trial data. Participate in meetings with regulatory authorities, addressing statistical… more
- Merck & Co. (North Wales, PA)
- …Clinical Research group. They will be responsible for all phases of the trial process, including but not limited to the design, oversight and medical monitoring ... as well as analysis, interpretation, and reporting of final clinical trial results.In addition to responsibilities associated with clinical research, the Clinical… more
- Eisai, Inc (Pittsburgh, PA)
- …experience in Oncology/Hematology.Strong broad-based scientific and pharmaceutical knowledge.Clinical trial development and drug launch experience is strongly ... and international travel may include spending time at cancer trial sites/institutions, conference center, offices and hotels.Possesses and maintains a… more
- Merck & Co. (Rahway, NJ)
- …a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials.- The knowledge must be sufficient ... and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to ... reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees the execution of… more
- Merck & Co. (North Wales, PA)
- …field plus 5 years SAS programming experience in a clinical trial environmentMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... related field plus 3 years SAS programming experience in a clinical trial environment- Department Required Skills and Experience: Effective interpersonal skills and… more
- Merck & Co. (North Wales, PA)
- …or related field plus 5 years SAS programming experience in a clinical trial environmentOR a master's degree (or US equivalent) in Computer Science, Statistics, ... or related field plus 3 years SAS programming experience in a clinical trial environment. Requirements: Experience in US and/or worldwide drug or vaccine regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor ... information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).- Under supervision, review… more
