- Merck & Co. (North Wales, PA)
- …teams for the strategic planning and execution for product development-Is involved in clinical development planning to ensure that study designs are consistent ... of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet objectives of the study...oral and written reports to effectively communicate results of clinical trials to the project team , company… more
- Pfizer (Collegeville, PA)
- …lead the way in healthcare and make a lasting impact on society. **ROLE SUMMARY** As a Clinical Study Team Lead (CSTL), you will be an integral member ... team delivery of multiple complex global studies and/or programs. Your clinical development expertise...operations + Accountable for issue escalation and resolution + Lead study team chartering and… more
- 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
- Organon & Co. (Plymouth Meeting, PA)
- … in accordance with the program plans and serve as an active member of the clinical study team . + Provide input to vendor selection and provide vendor ... collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies...in assigned asset development and sub- team meetings, clinical study team , modeling and… 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
- Organon & Co. (Plymouth Meeting, PA)
- …data analysis and clinical trial result interpretation based on the study protocol, including studies outsourced to CROs and assure adequate quality ... programing and Data Management, and the Late-Stage Asset Development Team leaders. + Design of the clinical ...R&D matters posed to Organon. + Ensure sound late-stage clinical study protocol designs that are aligned… more
- Merck (North Wales, PA)
- …global, cross- functional team members including clinical directors and study managers to lead /support clinical trial scientific activities. Job ... strategy and execution of Phase 1-4 clinical studies . Under the direction of the Program Lead...team . + Collaborates with the Medical Writer on clinical /scientific and regulatory documents. + Partners with Study… more
- Pfizer (Collegeville, PA)
- …for the BU related to Evidence Generation study activities, provide guidance to study team for ensuring correct study type and application of safety ... regulations. **Audit & Inspection Readiness and Preparation** + Provide Study Team with Audit & Inspection Readiness...alignment with RQA/CQA. + QCSLs work in collaboration with Study Teams and Audit Lead to prepare… 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
- Teva Pharmaceuticals (West Chester, PA)
- …the preparation/review of related key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The ... documents for IND/NDA and other regulatory documents + May lead an NDA submission team independently, as...and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant … 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
- CSL Behring (King Of Prussia, PA)
- …lead the development of Clinical Development Program. + Author clinical study documents and assists with development/critical review of submission ... office. You will report to the Director of Global Clinical Science Lead . **Responsibilities:** + You will...of clinical data and the writing of clinical study reports, internal and external scientific… 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
- 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
