- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Recursion (Salt Lake City, UT)
- …and diverse data sets, and sophisticated analytics. We are seeking a Lead, Clinical Data Manager who can lead and oversee end to end Clinical ... Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data -related deliverables....The Team You'll Join Reporting to the Senior Director, Clinical Data Management and working closely with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to determine risk factors with and for other technical departments (eg, Clinical , Medical, Safety, Data Management, Statistics). This position requires skills ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… more
- Eisai, Inc (Nutley, NJ)
- …strategies.Experience in managing and directing related functions such as data management, CRO vendor management, procurement, and contracting.Excellent ... your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …case review, documentation reviews in collaboration with the ICSR management and CRO /Vendor oversight groups for case processing activities and reports to the ... matter expert in ICSR standards, decision making and trouble shooting. Identifies CRO /vendor training as needed. Reviews overall processes and identifies areas of… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …and validation partnering with Translational Sciences colleagues when applicable Manages clinical biomarker data delivery and analysis and associated timelines ... of the Global Research organization in BMS and leads late stage clinical , pharmacological and translational research and development activities for the pipeline and… more
- Formation Bio (New York, NY)
- …drivers. Facilitate effective communication and collaboration between internal teams, such as Clinical Development, Clinical Data Management, and Site ... and comply with regulations. Capabilities to include the operational aspects of clinical trials, including protocol development, site selection, data collection,… more
- The University of Pennsylvania (Philadelphia, PA)
- …CRC will be responsible for the coordination of complex medical dermatology clinical research protocols, including accurate data collection and overseeing the ... quality of the clinical trial data and records, scheduling and conducting study initiation and...and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report… more
- CVS Health (Blue Bell, PA)
- …skilled and research driven Sr. Decision Scientist to lead and support strategic, data -driven initiatives that enhance clinical trial recruitment. In this role, ... compliant solutions. Design and manage cross-functional initiatives, coordinating between clinical teams, data engineering, operations, and external partners.… more
- BioSpace (Tarrytown, NY)
- …Oversees and provides hands on support in management, generation and dissemination of clinical and non- clinical data that supports the medical strategy ... interventional and non-interventional respiratory clinical trials. Attends clinical study team meetings, data oversight review...data oversight review sessions, and works closely with CRO medical monitors in support of medical affairs … more
- Scholar Rock (Cambridge, MA)
- …Safety Committee. Medical safety review including causality assessment of all available safety data generated from various sources (eg pre- clinical , clinical ... skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies. Scholar Rock is an Equal… more
- Invivyd (New Haven, CT)
- …safety database for tracking, storing, and reporting of serious adverse events from clinical trials , Provide direct technical / data management support to ensure ... years of pharmacovigilance experience at a biotech, pharmaceutical, or CRO company, with at least 6 years hands on...strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data Strong proficiency in… more
- Cedent (Boston, MA)
- CRO Regulatory Specialist Job Description The Regulatory Specialist ensures clinical trials operate within a compliant framework while supporting sponsors and ... and GCP requirements. This role serves as the liaison between clinical operations, quality assurance, and regulatory authorities. Reports to: Evidence Generation… more
- Dyne Therapeutics (Waltham, MA)
- …of statistical analysis, interpreting and communicating the results of statistical analysis of clinical trial data in support of regulatory submissions as well ... /randomization schema; review and approve test randomization lists Collaborate with Data Management, Clinical Development and Clinical Operations… more
- REGENXBIO (Rockville, MD)
- …As the In-house CRA you will support and coordinate the logistical aspects of clinical trial management, site management, data review and cleaning according to ... or designee Assists the CPM with the review of clinical database and management of flow of data...CRO and /or healthcare setting required Knowledgeable of clinical research operations, including interpretation and implementation of FDA… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the ... the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline… more
- Janux Therapeutics (San Diego, CA)
- Janux Therapeutics seeks a Director of Clinical Operations to lead early-phase autoimmune clinical trials from its newly announced A daptive Immune R esponse M ... and will be responsible for all aspects of assigned clinical trials. This role also assures adherence to GCP,...deliverables are completed on-time and within budget Vendor (eg, CRO , Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for… more
- MannKind Corporation (Bedford, MA)
- …Summarize results presented in graphical, tabular, and/or listing format. Interpret complex clinical data and convert it into clear, concise, and engaging ... At MannKind, we are driven by a mission to give people control of their health and the freedom to live life. We develop therapeutic products and devices that address… more
- Piper Companies (Farmingdale, NY)
- …and analyzing laboratory tests to support clinical research, ensuring quality control , regulatory compliance, and accurate data reporting in a fast-paced lab ... Medical Laboratory Specialist. Proficiency in laboratory techniques, instrumentation, and quality control procedures. Experience in a clinical laboratory or… more
- Olema Oncology (San Francisco, CA)
- …Affairs and Quality Assurance you will lead the development of labeling for clinical supplies as well as development of commercial labeling materials for Olema ... label implementation. This role will work closely internally with Regulatory Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA), and the… more
