- Pfizer (Collegeville, PA)
- …way in healthcare and make a lasting impact on society.** **What You Will Achieve** 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
- Merck (North Wales, PA)
- …execution of a clinical trial. + May serve as the clinical trial team lead + May lead team in key study planning, development, and execution ... (eg, study team , country teams, vendors, committees) in support of clinical study objectives. + Accountable for managing any study specific partners… more
- Merck (North Wales, PA)
- …for the operational planning, feasibility, and execution of a clinical protocol. May lead team in key study planning, development and execution elements ... plans, preparation of status update reports, study closeout activities). May serve as the clinical trial team (CTT) lead . Leads team for timeline… more
- Pfizer (Collegeville, PA)
- …for mitigation + Leader of the Local Study Team (core members: ( Lead ) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation ... The Study Operations Manager has responsibility for study management aspects of assigned studies of...larger Study Management team . The Study Operations Manager I may lead specific… 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
- Pfizer (Collegeville, PA)
- …to a team of medical directors and clinical scientists who lead the clinical study team for 1 or more medicines in prostate cancer + Oversee the ... of therapies for multiple medicines in prostate cancer + Lead product specific Global Development Team +... clinical protocols and amendments, investigator brochures, and clinical study reports + Provide oversight and… more
- Teva Pharmaceuticals (West Chester, PA)
- … trial design or execution. + A demonstrated competence and track record at Study Director/ Clinical Lead level. + Experience with site engagement, ... etc.), reviewing study data and providing expert clinical input. The incumbent will have a lead...+ Candidates should have experience and understanding of running clinical studies with substantial interaction with other… more
- CSL Behring (King Of Prussia, PA)
- …project size and complexity. You will lead overall clinical project management, lead the study execution team (SET) and coordinates study ... address study /program level issues. You will manage/mentor Clinical Study Managers (CSMs) and Clinical...eTMF) and standards to allow inspection readiness of all clinical studies and ensuring compliance with quality… more
- Teva Pharmaceuticals (West Chester, PA)
- …of Clinical Pharmacology (CP) will represent the CP department at internal ( study , project, clinical team ) and external meetings (with regulatory ... Pharmacology role is part of the broader Quantitative Clinical Pharmacology and Biosimilar Sciences (QPB) team ...CP related aspects of late stage clinical studies . + Optimize dosing regimens, study designs,… more
- Kelly Services (West Point, PA)
- …Clinical Scientist** **Description of Services** + Assists the CS Protocol Lead and study team with the clinical /scientific conduct of clinical ... May support a single study or multiple studies + May lead a study...( study sites, committees, etc.) in support of clinical study objectives **Minimum FTE Years of… more
- J&J Family of Companies (West Chester, PA)
- …accountabilities are in place to achieve rapid, cost- effective and well executed clinical studies , for the supported franchises delivering high quality ... are on-time and within budget. This leader leads a team of Clinical Operations associates and is...Reimbursement and Market Adoption needs. * Responsible to deliver clinical studies within clinical /… more
- Merck (Upper Gwynedd, PA)
- …to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and + Participation in internal and ... and supervise the activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in… more
- Pfizer (Collegeville, PA)
- …the appropriate roles in Clinical Development & Operations, the AQL will work with Clinical Study Team Quality Leads within their assets to ensure asset ... maintaining 'quality' line-of-sight for assets/protocols within the Pfizer Oncology clinical portfolio. + With this focus, the Asset Quality...in their tumor type(s). + Provide Study Team Inspection Readiness (IR) guidance and support; 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)
- …deliverables. The Senior Director will provide oversight and support the Primary Care Team Lead to drive and maintain functional excellence, strategy and ... tactical execution and refinement, study planning and execution for pipeline and marketed assets...team in support of strategy development and deepening team skills and competencies. + Lead the… more
- Teva Pharmaceuticals (West Chester, PA)
- …the CRO's charges. + Engage with procurement on contracts with CRO's for Innovative clinical studies , review and approve financial terms and confirm planning is ... planning and reporting. **How you'll spend your day** + Lead financial planning and reporting process and KPI's including...+ Advanced knowledge of budgeting and forecasting processes of clinical studies + Bachelors required. Preference MBA… more
- Merck (North Wales, PA)
- …Partner with squad members including but not limited to scrum masters, technical lead (s) and development team to manage high-quality product delivery leveraging ... **Job Description** Clinical Development heavily relies on accurate data collected...Trial experience for our patients. + Improve efficiency of study start up by reducing the time from … 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
- Merck (North Wales, PA)
- …and research activities. This position, under the supervision of a Research Management Team Lead , will execute a variety of research management activities ... and health outcomes for patients. The Research Management Operations team sits within the Real-World Evidence (RWE) Operations organization...starting from study execution to close-out and summarization of results from… more
- Pfizer (Collegeville, PA)
- …data solutions (Data Lakes and Associated Portfolios) supporting Pfizer's scientific and clinical functions. The Project Delivery Lead (DL) will ensure the ... development, deployment and maintenance of key systems supporting the clinical development portfolio. The DL will contribute to data strategies and lead the… more