- 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)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... and immune disorders.Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager...other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Taiho Oncology (New York, NY)
- …SLs, HCPs, and institutions in geography to be covered is preferred. Clinical trial development experience is preferred. Knowledge of treatment guidelines, ... dynamic and growing Medical Affairs Department. Position Summary: The Senior Medical Science Liaison ( Sr . MSL) is...Taiho products and relevant disease states, and facilitation of clinical research. The Sr . MSL integrates … 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. (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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Director and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations ... other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of...Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources… 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
- 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
- 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
- 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)
- …investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Clinical Science function. He/she will be responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each… 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
