- Merck & Co. (North Wales, PA)
- Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational ... quality management and inspection management activities.The CQOM will oversee headquarters clinical quality operations and support clinical trial teams… more
- Merck & Co. (Rahway, NJ)
- …protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and ... and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and ... oversight of relevant programming activities on the Biometrics vendor, ensure the quality and consistency of data standards to support the portfolio towards the… more
- Parexel (Juneau, AK)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical ... study execution in accordance with applicable prevailing laws, Good Clinical Practices ( GCP ), and sponsor standards. The...quality of investigator sites (eg patient safety, site quality and compliance with GCP ), to maintain… more
- Parexel (Columbia, SC)
- …Study Protocol (CSP) or ICH- GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining ... The Senior Clinical Research Associate (SrCRA) has...audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- **Title:** Senior Manager, Clinical Outsourcing Sun Pharma is the worlds fourth largest specialty generics company with presence in Specialty, Generics and ... focus on dermatology, ophthalmology and onco-dermatology. **Description:** Sun is seeking a Senior Manager, Clinical Outsourcing within its Clinical … more
- CSL Behring (King Of Prussia, PA)
- …the clinical & scientific oversight of the assigned program(s) and: **ensures high quality clinical & scientific standards are met during all aspects of the ... a meaningful difference worldwide. Could you be our next Senior Director, Global Clinical Program Lead, Cardiovascular?...of assigned clinical programs. + Ensures high quality clinical and scientific standards are met… more
- BeOne Medicines (San Mateo, CA)
- … studies of BTU assets, through partnering with execution units, that ensures clinical studies' quality and cost, meets planned timeline. **Roles & ... and ensure feasibility, study start-up, site management, drug supply and other clinical studies' activities operating according to GCP and Health Authorities'… more
- GRAIL (Menlo Park, CA)
- …technology, and healthcare companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead data management activities ... and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome… more
- GRAIL (Menlo Park, CA)
- …completion guidelines, and other related activities, supporting study requirements and data quality . + Oversees clinical data entry progress ensuring timely ... executed within compliance of regulations and of the highest quality , and to be able to identify areas of...GCP , ICH guidelines and other US and international clinical regulatory requirements + Working experience with an electronic… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical Directors, and Regulatory staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. + Focus on ... Medical and Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable for… more
- BeOne Medicines (San Mateo, CA)
- …Qualifications:** **Mid/large pharma experience (preferably clinical operations, process, quality , or compliance roles)** **ICH GCP subject matter expert** ... SOPs** **Effective partnership and collaboration with cross functional leaders/stakeholders (eg Clinical Development, Data Management, Quality , Regulatory) as it… more
- Arvinas (New Haven, CT)
- …disease experience /educational background required + Advanced knowledge of GCP /ICH, drug development process, study design, statistics, clinical ... Arvinas is a clinical -stage biotechnology company dedicated to improving the lives...Data management and other functional team members at assure quality and timely study conduct and monitoring + Provide… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Clinical Trial Coordinator (Sr. CTC) will be responsible for supporting ... the clinical project team during all stages of a ...Supports literature search activities as required. + Ensures data quality by reviewing completeness and accuracy of study data,… more
- Insmed Incorporated (NJ)
- …one compound to ensure all are delivered on time, within budget and with high quality . This role may manage clinical operations team members, as delegated by ... lead over an 1-2 indications within one compound, in collaboration with the Senior Director, Clinical Operations. Ensures consistent and successful execution of… more
- Parexel (Oklahoma City, OK)
- The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... study execution in accordance with applicable prevailing laws, Good Clinical Practices ( GCP ), and the Sponsor's standards....quality of investigator sites (eg patient safety, site quality and compliance with GCP ), to maintain… more
- Parexel (Madison, WI)
- …analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. ** Quality Control** + Ensure that all work is ... **Job Summary:** The Senior Medical Writer will research, create, and edit...drug development process, and industry guidelines and regulations, eg, ICH- GCP . + Extensive clinical /scientific writing skills. +… more
- Parexel (Washington, DC)
- Join our dynamic Patient Safety team as a ** Senior Physician** where you'll leverage your medical expertise to ensure the safety of patients in clinical trials ... directly impact patient wellbeing and regulatory compliance. **About the Role** As a ** Senior Physician in Patient Safety** , you'll serve as the medical authority… more
- Formation Bio (New York, NY)
- …including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices ( GCP ), Good Pharmacovigilance Practices (GPV) and Computer ... strategies that identify and address potential quality risks. Managing quality -related activities related to manufacturing, clinical trials, and nonclinical… more
- Teleflex (Minneapolis, MN)
- …Summary** 70% Travel The Sr. Field Vascular Intervention Specialist is a senior -level position that provides field support for clinical studies involving ... Senior Field Intervention Specialist (REMOTE) **Date:** Nov 20,...- Strong working knowledge and understanding of FDA, ICH, GCP regulations governing clinical trials, standard regulatory… more
