- Parexel (Harrisburg, PA)
- …Master File (TMF) + Responsible for liaising with local CRA/CTM, Contract Vendor, and Regulatory Lead to enable a rapid clinical trial start up. + Inform team ... SSU Lead or CTM, as appropriate. + Reviews and provide feedback to SSU Lead on site performance metrics. + Maintains and manages SSU data tracking entries,… more
- Merck (North Wales, PA)
- …support for related drug/vaccine projects in Late Development Statistics. + Lead the interaction with Clinical , Regulatory, Statistical Programming, Data ... staff assigned to a development project as needed + Lead biostatistics in early or late clinical ...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- ICON Clinical Research (Blue Bell, PA)
- …followed by End of Site ID analysis to be performed. To lead the process of clinical project feasibility during standalone feasibility (awarded) projects ... members, Project Managers/Strategy Leads, Patient Recruitment & Retention Specialists, Site Identification Managers/Leads, Therapeutic Experts, Therapeutically Aligned clinical… more
- Merck (West Point, PA)
- … clinical translation. **Key Responsibilities:** + **Strategy & leadership:** Develop and lead the clinical imaging strategy for application of novel PET ... scientific content for regulatory filings, including IND submissions. + **Partner and site management:** Coordinate with CROs, CDMOs, and clinical sites to… more
- Highmark Health (Pittsburgh, PA)
- …solutions with seamless omni-channel handoffs. As a key leader of the Medicaid Clinical organization, role is responsible for maximizing and optimizing value of the ... operational excellence/administrative cost management. This requires the incumbent to lead their team through the implementation of alternative resourcing strategies… more
- Pfizer (Collegeville, PA)
- …within the atirmociclib program. This individual contributor will be responsible for supporting clinical trial(s) and lead sub teams in clinical development. ... Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with ...requiring you to live within commuting distance and work on- site an average of 2.5 days per week Candidate… more
- Parexel (Harrisburg, PA)
- …oversee site activation processes, and ensure timely execution of clinical trials that align with project objectives and regulatory requirements across diverse ... position- can be US or Canada The Senior Manager, Site Start Up will oversee a portfolio of client...increase the quality, improve speed and efficiency of our clinical trials execution. **Key Accountabilities** : Oversight of activities… more
- Kelly Services (Malvern, PA)
- …(NPI) tech transfers into the manufacturing area to enable GMP production of DS clinical supplies + Setup and lead project kickoff meetings, weekly work-cells, ... transfer process + Act as the single point of contact (SPOC) between CMC teams, Clinical Supply Chain (CSC) teams and the Site Operations team, regarding tech… more
- Pfizer (Collegeville, PA)
- …the hematology program. This individual contributor position will be responsible for supporting clinical trial(s) and lead subteams in clinical development. ... Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with ...requiring you to live within commuting distance and work on- site an average of 2.5 days per week** The… more
- Merck (Upper Gwynedd, PA)
- …clinical strategy for novel Immunology assets and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early ... science of preclinical discovery into compounds ready for assessment in large clinical populations. We are seeking a highly qualified physician-scientist with a… more