- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational ... 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)
- …if scenarios and modelling for increased transparency on impact to clinical trial operational designs, timelines, and operational costs.Identify opportunities ... (eg study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.Responsibilities:Execute on end-to-end operational feasibility… 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 ... activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical ...different skills and expertise of data management within a clinical trial team-- - Benefits of Fellowship… 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 ... and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your...and expertise of the cross functional members of a clinical trial team. -Benefits of Fellowship Mentoring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and ... with minimum of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …build 'inspection readiness', identify and mitigate clinical quality risk with the clinical trial teams during study start up, conduct and close out/study ... centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness...of 3-5 years' experience in pharmaceutical or biotechnology in clinical trial operations or clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting ... in accordance with DS standards. Act as the project manager of the clinical study team to...to the CRO, but includes ancillary vendors (eg translations, trial insurance, and central laboratory).Work closely and oversee CRO… more
- Merck & Co. (Rahway, NJ)
- …internal and external stakeholders (eg, study team, vendors, committees) in support of clinical trial objectives. You will be part of a diverse, cross-functional ... and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your...tools critical to the oversight and conduct of a clinical trial . Participate in team meetings to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Merck & Co. (Rahway, NJ)
- …Job Responsibilities: - Responsible for the operational planning, feasibility, and execution of a clinical trial .- May serve as the clinical trial ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… 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 ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Degree preferably in Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical ... preferred.Excellent time management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution requiredStrong experience in procedural writing and life cycle management requiredAdditional clinical trial process experience in one or more key ... around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be… 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% ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. The GTL… more
- IQVIA (Newark, NJ)
- **Elevate Your Career as a Clinical Trial Vendor Manager !** **About the Role:** Step into a world where your expertise in clinical vendor management ... becomes the catalyst for advancing medical breakthroughs. As a ** Clinical Trial Vendor Manager ** , you'll play a key role in our clinical operations,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … study and regulatory documentation and SOPs. + Meets all requirements for Senior Clinical Trial Manager (Senior CTM) grade 28 position with demonstrable ... Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Clinical Operations is responsible for the worldwide execution of all Phase… more
- Pfizer (New York, NY)
- …+ Document Management functions + Coordinate TMF Lock process & activities across clinical trial portfolio + Identify and resolve operational issues and ... Knowledge of quality requirements across a range of different countries + Clinical Trial Execution + Clinical Documentation + Vendor Management and Oversight… more
