- 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
- 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
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Lead Clinical Oversight Manager? The job is located in the King of Prussia ... the processes (eg eTMF) and standards to allow inspection readiness of all clinical studies and ensuring compliance with quality standards. Manage internal… more
- CSL Behring (King Of Prussia, PA)
- …develop the operational strategy for a clinical studies and a clinical prgrams and the end-to-end study delivery of all operational activities and budget ... Trial Leaders. **Responsibilities:** Plan and build one or more clinical studies /programs: ** Lead the SET...EC/ IRB and regulatory submissions** **Ensure internal and external study team members are trained on the… more
- Pfizer (Collegeville, PA)
- … Lead (and members of the development team ) to establish, lead , coordinate, and execute the early oncology clinical development plan(s) for one ... signals of efficacy (ESOE) and proof of concept (POC) studies . + *The OES Clinical Scientist (Senior...protocol and may participate as an individual contributor on clinical study teams and clinical … more
- Merck (Upper Gwynedd, PA)
- …planning and execution of one or more clinical trials. Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical ... team . Job Responsibilities + Responsible for specific clinical /scientific activities on a single study or...for specific clinical /scientific activities on a single study or across multiple studies (eg, medical… 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
- Pfizer (Collegeville, PA)
- …excellence in support of strategic imperatives and in collaboration with the cross functional study team (s) + Ensure work carried out by or on behalf ... consistency in asset/submission data. **KEY RESPONSIBILITIES** + Serve as Clinical Data Scientist and Trial Lead for...clinical trials and ability to assess and determine study requirement from protocol review + Strong Project and… more
- Pfizer (Collegeville, PA)
- …functional lines at the core study team . The SCL provides study teams with innovative solutions to clinical drug supply production, packaging, labeling ... execution. The SCL is the matrix team lead of the MedSci GCS Clinical Supplies...of the clinical development program and project team objectives. Participate as a core study … 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)
- …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 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
- J&J Family of Companies (Spring House, PA)
- …in accordance with internal processes, with some mentorship from functional management and clinical team , as needed. + If a lead writer for a program: Be the ... clinical documents such as, but not limited to, clinical study reports, investigator's brochures, study...contact and champion for medical writing activities for the clinical team . Responsible for planning, setting strategy,… more
- Merck (North Wales, PA)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... clinical documents including development plans, protocols, trial related documents, clinical study reports and background documents. + Interfaces with… more
- Teva Pharmaceuticals (West Chester, PA)
- …including GCP, GLP, GMP, GDP and ICH guidelines and other guidelines applicable for BE/ clinical studies . Working knowledge of the Clinical Trial Supply ... Clinical Packaging, Clinical Supply Chain and Research and Development (R&D) team members to negotiate timelines, strategies and other related topics for all … more
- Merck (West Point, PA)
- …or West Point, PA) is also based on the location of the host team . ** Clinical Quality Assurance (CQA) Co-op Opportunity:** Our Research and Development ... Division's Clinical Quality Assurance (CQA) team serves as...serves as an essential independent function with accountability to lead and support audits focused on a risk-based approach… more
- Merck (North Wales, PA)
- …if we are the right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for summer interns. GCTO ... diverse development portfolio. It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company… more
- J&J Family of Companies (Horsham, PA)
- …, investigator-initiated and/or collaborative studies in the Dermatology TA. Contribute/ lead study design, protocol development, clinical study ... * Dermatology or immunology therapeutic area expertise is highly preferred * Experience with clinical study , registry, or real-word evidence study and prior… more
- University of Pennsylvania (Philadelphia, PA)
- …closely with Physician leader and Lead Research Nurse of this CRU Research Team to oversee all aspects of the clinical research portfolio being performed for ... the Physician Leader of the Abramson Cancer Center (ACC), Clinical Research Unit (CRU)- Myeloma Research Team ...study . + Closely monitor and report to their team the status of all studies within… more
- J&J Family of Companies (Horsham, PA)
- …, investigator-initiated and/or collaborative studies in the Gastroenterology TA. Contribute/ lead study design, protocol development, clinical study ... we all belong. The Medical Affairs Therapeutic Area (TA) team is responsible for developing, coordinating and executing the...therapeutic area expertise is strongly preferred. * Experience with clinical study , registry, or real-word evidence … more