- CSL Behring (King Of Prussia, PA)
- …(CTS) Senior Study Manager manages the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. The CTS Senior ... Study Manager independently leads clinical studies to ensure compliant,...projects for the clinical supply chain. + Lead an improvement project team ; may have… more
- CSL Behring (King Of Prussia, PA)
- …be responsible for the overall Site Management activities of the CSAs of one or more Clinical Studies and the overall study site relationship status for the ... and often rare conditions. Could you be our next Lead Clinical Site Ambassador? The job is...Reports, CSA and Site Training)** + **Member of the Study Execution Team (SET) responsible for the… more
- Pfizer (Collegeville, PA)
- …etc.), and lead translation of pre- clinical observations into clinical experiments and studies designed to demonstrate proof of pharmacology, proof ... **ROLE SUMMARY** The Clinical Lead (CL), Internal Medicine RU...of clinical research plans into efficiently delivered studies . Creative in the conception of novel study… more
- System One (King Of Prussia, PA)
- …with cross-functional teams, external partners, and support Data Managers, may serve as the lead study data manager for a large, complex trial or multiple, ... Responsibilities: * As the main point of contact to Study Team , work collaboratively with cross-functional ...high level of expertise in data management to support clinical studies . * Provide clear verbal or… more
- Pfizer (Collegeville, PA)
- … Clinical Scientist, Clinical Data Scientists along with other members of the study team to determine what data will need to be reviewed. In addition, the ... RESPONSIBILITIES + The CDR is routinely responsible for the clinical data review of one or more studies...the presence of a blood pressure value that satisfies study inclusion criteria) and interpretive analysis (eg, evaluating subject… more
- Pfizer (Collegeville, PA)
- …system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions. + Plan and execute communication ... processes to meet timelines and deliverables. + Serve as Clinical Data Scientist and Trial Lead for...Data Monitoring and Management (DMM) activities and interact with Clinical Data Scientist at study level for… more
- Pfizer (Collegeville, PA)
- …utilizing system information, as well as applicable study documentation. + Liaise with Study Team Point of Contact, Document Owners, Trial master file (TMF) ... investigate any potential discrepancies and review findings with the study team Point of Contact to verify....tools. **Nice-to-Have** + Experience in management of medical and clinical study records and documentation. **Other Job… more
- CSL Behring (King Of Prussia, PA)
- …(DT)** You are the " Lead Author" or "Contributing Author" for: **Main study documents, including Investigator Brochures (IB), Clinical Study Protocols ... are met during the program** **Provide medical oversight and expertise during development of clinical studies ** **Be a medical monitor for assigned clinical … more
- Teva Pharmaceuticals (West Chester, PA)
- …needed: + Development and validation of surrogate biomarkers in early phase clinical studies . Functional Knowledge: + strategic and statistical leadership to ... department, complex clinical studies or programs across multiple diseases....using analysis to drive solutions + Persuade and inspire team to take action; Expert negotiation skills; lead… more
- Pfizer (Collegeville, PA)
- …**How You Will Achieve It** + Work closely with department roles and cross-functional study team members to create data capture solutions that support the ... will contribute towards the goals and objectives of the team . Your focus and ability to meet team...process and data operations required for the reporting of clinical trial data (eg data review, study … more
- Charles River Laboratories (Wayne, PA)
- …from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone ... Scientist responsible for the management and scientific oversite of assigned studies within the analytical laboratory including development and execution of highly… more
- Teva Pharmaceuticals (West Chester, PA)
- …of a disease area fellowship is also preferred + Demonstrated competence and track record at Study Director/ Clinical Lead level + Experience with FDA or EMA ... protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.), reviewing study data and… more
- Pfizer (Collegeville, PA)
- …focus areas in inspection coordination, including inspection responsibilities around: + Directing asset/ study team colleagues within CS&O/ Clinical to ensure ... The "Senior Issue Lead , Inspections" will be accountable to drive GCP...+ Communicating audit and inspection progress and needs to CS&O/ Clinical stakeholders + Serving as the point of contact… more
- Charles River Laboratories (Wayne, PA)
- …from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone ... and execution of highly complex method development and characterization studies related to the testing, characterization, and analysis of… more
- Merck (West Point, PA)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... perspective into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to… more
- Charles River Laboratories (Wayne, PA)
- …from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone ... characterization instrumentation and methodologies. * Generate high quality method and study protocols for sponsor and internal characterization and sample testing… more
- Elevance Health (Wilmington, DE)
- …active monitoring studies . + Provide epidemiology subject matter expertise and lead or support research activities related to scientific study design, ... Institute (PPI). **How you will make an impact:** + Lead and support the design and execution of pharmacoepidemiology... or support the development of detailed specifications for study databases and analysis files, consistency checks, tables, and… more
- Pfizer (Collegeville, PA)
- …in the Primary Care Division in close partnership with the cross-functional matrix team . + Lead the coordination of input from local country/regional teams ... part of Pfizer's dynamic Global Access & Value (GAV) team and will have the important role of managing...Lead the design and execution of global HEOR studies (eg, economic models, network meta-analyses, non-interventional studies… more
- Merck (West Point, PA)
- **Job Description** Under the general direction of the Epidemiology Oncology team lead , the Principal Scientist, Epidemiology, has responsibility for the design, ... risk management, post-marketing safety studies , post-authorization effectiveness studies , regulatory activities, endpoint qualification/standardization/training for clinical … more
- Merck (West Point, PA)
- …and problem scoping and planning. + Demonstrated ability to participate in and to lead an interdisciplinary team , and to oversee the work of other scientists. ... registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to… more