- Merck & Co. (North Wales, PA)
- …teams for the strategic planning and execution for product development-Is involved in clinical development planning to ensure that study designs are consistent ... of novel 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
- 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
- Organon & Co. (Plymouth Meeting, PA)
- … in accordance with the program plans and serve as an active member of the clinical study team . + Provide input to vendor selection and provide vendor ... collaboration with the TMED operations lead and study biostatistician), analysis and interpretation of TMED studies...in assigned asset development and sub- team meetings, clinical study team , modeling 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
- J&J Family of Companies (Horsham, PA)
- …the status of clinical study activities + Review and assessment of new clinical study proposals + Lead company sponsored study development from ... related materials, feasibility, site selection and investigator meetings through study close-out, clinical study report...The individual must have demonstrated ability to work and lead in a cross-functional team environment and… more
- Pfizer (Collegeville, PA)
- … Clinical Scientist, Clinical Data Scientists along with other members of the study team to determine what data will need to be reviewed. In addition, the ... RESPONSIBILITIES + The CDR is routinely responsible for the clinical data review of one or more studies...the presence of a blood pressure value that satisfies study inclusion criteria) and interpretive analysis (eg, evaluating subject… 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
- Merck (North Wales, PA)
- …global, cross- functional team members including clinical directors and study managers to lead /support clinical trial scientific activities. Job ... 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)
- …for the BU related to Evidence Generation study activities, provide guidance to study team for ensuring correct study type and application of safety ... regulations. **Audit & Inspection Readiness and Preparation** + Provide Study Team with Audit & Inspection Readiness...alignment with RQA/CQA. + QCSLs work in collaboration with Study Teams and Audit Lead to prepare… 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
- J&J Family of Companies (Spring House, PA)
- Manager, Global Clinical Operations (GCO) Learning & Training, Learning and Instructional Design - 2406218628W **Description** Johnson and Johnson is recruiting for ... a **Manager, Global Clinical Operations (GCO) Learning & Training, Learning and Instructional Design** located in Titusville, NJ; Raritan, NJ; Spring House, PA;… 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
- 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
- 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
- Organon & Co. (Plymouth Meeting, PA)
- …statistical integrity, adequacy, and accuracy in clinical development plans, clinical protocols, clinical study reports, regulatory documents, ... sample size and power calculation for all kinds of clinical study design. + Demonstrated experience in...providing statistical input and direction into the design of clinical studies , data analytic approaches, interpretation of… 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
- J&J Family of Companies (Horsham, PA)
- …and R&D teams on key access trends and opportunities. * Provide leadership to the Clinical Development Team (CDT)in terms of market access data needs related to ... * Lead an engaged and collaborative Extended Market Access team , ensuring great communication and collaboration, sharing of best practice and co-creation.… 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
