- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Director, Global Clinical Trial Operations (GCTO) Project Management Office (REMOTE) The core responsibility of this ... execution and coordination of major change projects across Global Clinical Trial Operations (GCTO). The role will...are updated and readily available for internal teams and senior leaders. Upon completion of a project ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …industry experience in trial diversity and patient access and/or clinical operations project management (required) required- Demonstrated success in working ... around rare diseases and immune disorders.Summary The Head of Clinical Trial (CT) Diversity sits within Global... trials- Monitor data and regularly communicate findings to senior leadership to make recommendations for process improvements -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Merck & Co. (North Wales, PA)
- …execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring ... and prioritization skillsStrong analytical skills with the ability to interpret clinical trial data and synthesize conclusionsInteract with key stakeholders… more
- Merck & Co. (Rahway, NJ)
- …team-- - Benefits of Fellowship - Mentoring & networking opportunities within and beyond Clinical Trial Operations Exposure to Senior level positions within ... Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical...tools critical to the oversight and conduct of a clinical trial - Participate in team meetings to… 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 ... Are you ready to make a difference?The Position The Senior Medical Writer works closely with cross-functional project...to detail to ensure the accuracy and consistency of clinical trial documents A strong foundation in… more
- Merck & Co. (Rahway, NJ)
- …understanding of the systems and tools critical to the oversight and conduct of a clinical trial . Participate in team meetings to develop an understanding of the ... The Fellowship will include progressive on-the-job training and operational project assignments under the direction of Lead Clinical...and expertise of the cross functional members of a clinical trial team. -Benefits of Fellowship Mentoring… more
- Merck & Co. (North Wales, PA)
- …trials. Job Responsibilities: Responsible for the operational planning, feasibility, and execution of a clinical trial .May serve as the clinical trial ... PowerPoint, Word, Outlook, etc.)Education/Experience:Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or-medical field… 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 ... Job DescriptionPosition Description: Senior Study Manager - Cardiometabolic Our Clinical...site selection criteria with cross-functional team.-Works closely with Global Trial Optimization (GTO) to: develop patient recruitment and retention… more
- Merck & Co. (North Wales, PA)
- …or related field and at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science, Statistics, Applied Mathematics, Life ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...at least 3 years SAS programming experience in a clinical trial environment. Required Skills: Effective interpersonal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical ... diseases and immune disorders. Summary This position is a Clinical Science lead position and will lead a group...position may be at the executive director level or senior director level, depending on the scope and size… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …methods to resolve clinical development problems Work with the larger Global Project Team to deliver excellent medical support for DCR-PHXC and other clinical ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetic, exposure-response, quantitative system pharmacology, and other model-based analyses.-Perform clinical trial simulations to inform dose selection ... the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigators is expectedThe CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Global Clinical Science functionHe/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a proactive safety strategy for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with PSLs/GPTs on ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
- Merck & Co. (Rahway, NJ)
- …must include 3 years in the following: SAS programming in a clinical trial environment, including data steps, procedures, SAS/MACRO, SAS/GRAPH, SAS ... Job DescriptionResponsibilities:Support statistical programming activities for clinical development projects.This may include leadership of one or more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and suggest innovative approaches to improve compliances and processes.- Some knowledge of clinical trial methodologies. Travel Ability to travel up to 10% ... and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... lifecycle of the actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose… more
