- Pfizer (Collegeville, PA)
- …appropriate. + Reviews and queries safety and efficacy data in support of the clinical data review strategy and collection of quality data and review of ... **Position Summary** You will provide scientific oversight and support data integrity and quality of clinical trial(s)...7 years of experience in a similar role in industry/ CRO . + Clinical Research experience in the… more
- University of Pennsylvania (Philadelphia, PA)
- …for IITs where collaborating physician is the Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; ... research performed. He/she will be responsible for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject… more
- University of Pennsylvania (Philadelphia, PA)
- …CRC will be responsible for the coordination of complex medical dermatology clinical research protocols, including accurate data collection and overseeing the ... quality of the clinical trial data and records, scheduling and conducting study initiation and...and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report… more
- University of Pennsylvania (Philadelphia, PA)
- …performed. He/she will be responsible for supporting the following aspects of clinical trial coordination including subject recruitment, detailed data entry, ... The CRC will assist in the coordination of complex clinical research protocols, including accurate data collection...and maintain all documentation required by the sponsor or CRO per GCP - includes source documentation, case report… more
- ThermoFisher Scientific (Allentown, PA)
- …of issues in consultation with the Global Medical Indication Lead + Interpret the clinical trial data for regulatory documents (eg CSR, INDs, Annual Reports, ... team, in order to provide reliable, high quality study data within time and budget. **A day in the...years of industry experience required. Experience should be in clinical development in a Pharmaceutical, Biotech or CRO… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …day-to-day operations of assigned trial(s), as assigned.** **Participates in ongoing review of clinical trial data focusing on data integrity, trending and ... **Job Summary** Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …associated follow-up activities (eg, reports, corrective actions). + Perform reviews of clinical study documentation for data integrity and compliance with GCP ... guidelines and regulation, including Quality Control checks of the eTMF to ensure it is...development, and outside vendors where applicable. + Experience auditing clinical vendors, Clinical Research Organizations ( CRO… more
- Organon & Co. (Plymouth Meeting, PA)
- …with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control (CMC), ... 1 to 2a study protocols, in collaboration with internal (biostatistics, clinical operations) and external (contract research organization [ CRO ], bioanalytical… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …innovations to add value. + Provide strategic oversight in our vendor and CRO relationships and provide clinical input into their governance committees. + ... + Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …to add value strategically. + Provides strategic oversight in our vendor and CRO relationships and provides clinical input into their governance committees. + ... + Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical… more