- 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
- 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
- Merck (Upper Gwynedd, PA)
- …with global, cross-functional team members including clinical directors and study managers to lead /support clinical trial scientific activities in ... 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)
- …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
- 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
- IQVIA (Bethlehem, PA)
- …a member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and ... Lead for partnering in overall project management, Clinical Lead for site management, the Project...program, responsibilities might include: + Provide input to integrated study management plans with the core project team… 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
- Merck (West Point, PA)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... insight into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human… more
- Merck (West Point, PA)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... perspective into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to… more
- Merck (Upper Gwynedd, PA)
- …a development project as needed + Lead biostatistics in early or late clinical development planning to ensure that study designs are consistent with program ... for related drug/vaccine projects in Late Development Statistics. + Lead the interaction with Clinical , Regulatory, Statistical...the strategic planning and execution for product development + Lead a team of statistical and/or programing… more
- Merck (North Wales, PA)
- …for the strategic planning and execution for product development + Is involved in clinical development planning to ensure that study designs are consistent with ... 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
- Merck (West Point, PA)
- **Job Description** Under the general direction of the Epidemiology Oncology team lead , the Principal Scientist, Epidemiology, has responsibility for the design, ... risk management, post-marketing safety studies , post-authorization effectiveness studies , regulatory activities, endpoint qualification/standardization/training for clinical … more
- Merck (West Point, PA)
- …and problem scoping and planning. + Demonstrated ability to participate in and to lead an interdisciplinary team , and to oversee the work of other scientists. ... registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to… more
- J&J Family of Companies (Spring House, PA)
- …prioritize multiple projects + Able to manage time and elevate relevant issues to other team members and team lead + Detail oriented with excellent verbal ... to be assessed for optimal experimental design of the study + Work as a key team ...and troubleshoot experiments, analyze/ report/present data and collaborate with team members to design studies + Experience… more
- J&J Family of Companies (Spring House, PA)
- …involved in process design, unit operation development, and parameter optimization studies resulting in the development of new production processes. The successful ... will work as part of a cross-functional teams supporting pre- clinical and clinical programs, focused on autologous...not limited to: + Design and execute process development studies using sound scientific and engineering principles to develop… more
- ThermoFisher Scientific (Allentown, PA)
- …Conditions** Office **Job Description** As part of the Thermo Fisher Scientific team , you'll discover meaningful work that makes a positive impact on a ... distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our… more
- Merck (North Wales, PA)
- …in a cross-functional manner and understands the various steps in the lifecycle of a clinical study + Knowledge of the Drug Discovery Process, ICH and GCP ... decisions, improve planning/execution, and monitor performance across our portfolio, studies & processes within Global Clinical Trial...: + At least 8 years working on a clinical trial team or has worked in… more
- Merck (West Point, PA)
- … lead within SDPC. The role is targeting an individual that could be tasked to lead the drug product team tasked to deliver a new product. This position may ... position include but are not limited to the following:** SDPC Drug Product Working Group Lead or Team Member + Responsible for the commercialization of a sterile… more
- ThermoFisher Scientific (West Point, PA)
- …Interpret, and Review an inventory management plan to forecast the supply of study drugs to global clinical trials using sound supply chain techniques. ... be considered). + Understanding of clinical supply requirements, phases of clinical development, and the factors that influence study designs preferred.… more