- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... data, lab data, other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager ...requirements for quality data collection and validation at the trial level.Reads and interprets the clinical protocol… more
- Novo Nordisk Inc. (San Antonio, TX)
- …NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with multiple internal stakeholders relevant to ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Novo Nordisk (eg, clinical trial site staff, IRBs, clinical research vendors). Manages relationships with multiple internal stakeholders relevant to ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Merck & Co. (North Wales, PA)
- …clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... team members including clinical directors and study managers to lead/support- clinical trial scientific activities.Job Responsibilities Responsible for the … more
- Merck & Co. (North Wales, PA)
- …for the scientific aspects of the implementation and conduct of a clinical trial (eg, investigator meeting presentations, safety and medical monitoring)May ... serve as the CSSM scientific representative on the Clinical Trial Team (CTT)May work closely with...Team (CTT)May work closely with the Medical Writer on clinical /scientific and regulatory documents and the Study Manager… 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 ... other third party vendors to ensure compliance with the protocol, external/ internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines,… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking ... sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study...continuity of site relationships through all phases of the trial .Performs clinical study site management/monitoring activities in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... oncology, immunology, or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is a… 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
- 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...Assess training gaps and identify role-specific learning requirements (SOPs, internal processes, etc.) in partnership with CMR Subject Matter… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …datasets and TFLs to improve efficiency and quality.Responsibilities- By leading internal programming contractor or by self, perform programmatic review of analysis ... deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds… more
- Aequor (Piscataway, NJ)
- …The S/MMC is expected to: Possess ability to understand and interpret clinical trial data, the literature and associated therapeutic conditions Coordinates ... Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule:...Ability to establish and leverage relationships with external experts, clinical trial investigators, journal editors, and congress… more
- Merck & Co. (Ames, IA)
- …, FDA, CFIA and USDA regulatory policies.- The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials ... for all of our Company's Animal Health Division products. Perform field trial evaluation of newly license products to offer technical support information for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data ... for upcoming audits. Complies with the protocol, Policies, SOPs, external/ internal standards, pertinent Good Clinical Practices (GCPs),...or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab… more
- DivIHN Integration Inc (San Diego, CA)
- …please contact one of our Talent Specialists Sivanesan at 224 369 0756 Title: Clinical Trial Assistant (CTA) Location: San Diego, CA Duration: 12 Months ... have experience working with biological specimens and data sets, ideally with some clinical trial familiarity Will be providing general administrative support to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… 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
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop ... efficiency and effectiveness, including Medical Expert mapping and profiling tools, manager coaching tool, etc. Identify innovative solutions to solve business… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- …medical device and/or pharmaceutical industry.Master's degree or Ph.D. preferred.Familiarity with clinical trial design, conduct, and oversightExperience in EU ... Overview We are hiring a Clinical Affairs Program Manager . The ...Internal /External and Customer Audits, as it relates to clinical dataChange assessment to product design, specifications, or product… more
