- Novo Nordisk Inc. (Plainsboro, NJ)
- …specifically aligned with the planning & successful delivery of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) ... in the pharmaceutical industry (Pharma/Biotech/CRO) Previous experience leading cross-function clinical trial operations teams preferred Expert in ICH-GCP… more
- Novo Nordisk Inc. (WA)
- …role and responsibilities Drives recruitment and retention strategies to support clinical trial sites to meet country enrollment and retention targets ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Merck & Co. (Rahway, NJ)
- …of Contact (POC) for assigned protocols and link between Country Operations-and clinical trial team (CTT).Responsible for project management of the assigned ... the-different local country roles ensuring a strong collaboration (including the CTC Clinical Trial Coordinator, CRAs and-COM Clinical Operations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... around rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study… more
- Catalent (MA)
- …robust network built around flexible and integrated service offerings for pharmaceuticals in clinical trial phases I-IV. We provide reliable service and deep ... Job DescriptionAccount Director, Clinical Development & Supply With ten facilities in...the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The… more
- Merck & Co. (Rahway, NJ)
- …and ensures continuity of site relationships through all-phases of the trial .Performs clinical study site management/monitoring activities in compliance with ... site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...to study deliverables; Provides input on ICF creation; Oversees recruitment and retention; establishes and implements contingency plans for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports (CSR) Investigator brochures (IB) Informed consent and assent forms Lay summaries of clinical trial results Clinical evaluation plans (CEP) and ... to detail to ensure the accuracy and consistency of clinical trial documents A strong foundation in...desired Managerial experience: None We commit to an inclusive recruitment process and equality of opportunity for all our… more
- Merck & Co. (North Wales, PA)
- …preparation of status update reports, study closeout activities).- May serve as the clinical trial team (CTT) lead. -Leads team for timeline management, risk ... sitesEstablish site selection criteria with cross-functional team.-Works closely with Global Trial Optimization (GTO) to: develop patient recruitment and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …value of assets and the enterprise as well as providing strategic input into clinical trial strategy and regulatory development. With a holistic overview across ... launch) Commercial Strategic Input: Provide strategic input into early-stage pipeline clinical trial activities ensuring alignment with regulatory requirements… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready...members (eg from Japan, China, Australia, Canada, Korea etc.) Recruitment in EU: It is critical that this person… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization applications (MAA), ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...mentoring medical writers desired We commit to an inclusive recruitment process and equality of opportunity for all our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... in the unique opportunity to bring highly innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail oriented… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... communications, and training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites and risks to… more
- Careerbuilder-US (Cambridge, MA)
- …potential and enrolled research participants during conduct of a clinical trial including but not limited to recruitment , screening, informed consent ... technologies. . The CRA, in close partnership with the Clinical Trial Manager has responsibility to assist...or may manage a unique part of studies (eg recruitment , scheduling, and ISF filing). . This individual provides… more
- Novo Nordisk Inc. (Philadelphia, PA)
- …Sales Representative also assists their target physicians with their local clinical and educational initiatives by coordinating company resources (eg, counterparts, ... timely and accurate transmission of call data Understand the scientific and clinical underpinnings of brand strategies and the implications and importance of… more
- Catalent (Philadelphia, PA)
- …to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.Includes review of material status, protocol conformance, ... located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical … more
- Insmed Incorporated (Bridgewater, NJ)
- …Associate Director of Biostatistics is responsible for the statistical aspects for complex clinical trial (s) or indication product line. This role leads the ... section development, study setup, execution, analysis, and reporting of clinical trials, and interacts with cross-functional teams.ResponsibilitiesAdditional representative responsibilities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …is preferred A minimum of eight (8) years of progressively responsible clinical development/ trial experience within a pharmaceutical, biotechnology, or CRO ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...the knowledge gaps (for example: New TA knowledge, New Trial /Protocol etc.) Collaborate with Subject Matter Experts to ensure… more
- Merck & Co. (Boston, MA)
- … pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic oversight for the early … more
