- Regeneron Pharmaceuticals (Armonk, NY)
- …to Clinical Trial + Management System (CTMS) and Trial Master File ( TMF ) + Contributes to investigator meeting preparation and execution + Oversees engagement, ... but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability + May be responsible for mentoring clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... Clinical Study Oversight Plan (CSOP). **Responsibilities** + Reconcile the TMF document trackers generated by the CRO with the...with the reconciliation to the attention of the Study Manager and propose remediation plan. + Distribute key study… more
- Novo Nordisk (Lexington, MA)
- …for patients. The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work in a growing Clinical Operations ... subject recruitment materials + Oversee the Trial Master File ( TMF ) and assist with periodic audit of the ...least 3-5 years of experience as a Clinical Trial Manager + Experience with global clinical trial operations, in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Clinical Study Associate Manager (CSAM) role supports the Clinical Study Lead by taking responsibility for areas of clinical trial delivery. This role applies to ... limited to Clinical Trial Management System (CTMS) and Trial Master File ( TMF ) Contributes to investigator meeting preparation and execution + Oversees engagement,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …but not limited to Clinical Trial Management System (CTMS), Trial Master File ( TMF ) etc. + Ensures compliance with the clinical trial registry requirements + ... but not limited to database lock, reconciliation of vendor contracts, budget, TMF , and study drug accountability + Contributes to clinical study report writing… more
- University of Pennsylvania (Philadelphia, PA)
- …and resources, and much more. Posted Job Title Sr. Clinical Trial Project Manager (Center for Cellular Immunotherapy) Job Profile Title Manager Research Project ... phase clinical trials. Job Description The Sr. Clinical Trials Project Manager position works within the Center for Cellular Immunotherapies Clinical Operations… more
- BeiGene (Emeryville, CA)
- …on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at ... QC'd on a regular basis as per the study TMF QC plan + Provides input to Global Clinical...Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members + May support clinical ... with instruction + Provide regular and timely updates to manager /management as requested + Develop Protocol and ICF documents...+ Conduct literature review + Submit clinical documents to TMF + Develop site and CRA training materials and… more
- Actalent (Newark, NJ)
- …Great opportunity to join a growing pharmaceutical company! The Study Start Up Manager will work with the Executive Director and VP of Clinical Operations to ... sure all information is accurate. The Study Start Up Manager will serve as the main point of contact...activation and ensure essential documents are filed in the TMF enterprise system (Veeva) + Ensure timely delivery of… more
- Bristol Myers Squibb (Madison, NJ)
- …governance committee and development team meetings + Submission of clinical documents to TMF + Development of site and CRA training materials and presentation at ... development + May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross functional study team members + Collaborate and… more
- BeiGene (San Mateo, CA)
- …will serve as a GCP compliance expert to the organization. Additionally, Manager , GCP Compliance will assist with proactive and continuous process improvement, ... and action items related to CAPAs. + Track GCP audits of vendors, sites and TMF and ensure findings are fed back into the GCP inspection readiness program or… more
- Bausch Health (Bridgewater, NJ)
- …and information to support regulatory audits. Provide regular updates to the TMF as per departmental and Corporate requirements that comply with all regulatory ... requirements. + Participate in clinical study team meetings, align with study details, and collaborate in meeting study objective, and provide supporting information to the teams (includes RA, RACMC, Clinical Operations, Manufacturing and Development)… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …all required study programming documentation required for Trial Master File ( TMF ) - Maintain institutional knowledge across oncology compounds and support building ... up oncology programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: contribute to CRF and SDTM standard development, support develop, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standard,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …management of DS Safety Notification Letter (SNL) System and manages uploads to TMF activities. This position will interact with global study teams and represent PV ... operations in global interactions with CS Physicians and other study team members. This position will also engage within CSPV and with CROs to execute study start up processes. **Responsibilities** + Global PV Operations Representation on Clinical Study Teams:… more
- BeiGene (Emeryville, CA)
- …study is created, maintained and QC'd on a regular basis as per the study TMF QC plan + Collaborates closely with Global Clinical Supplies to forecast study drug and ... timely delivery of supplies to sites + Supports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders (including but not limited to regional clinical operations teams and medicator monitor) +… more
- WuXi AppTec (Austin, TX)
- …Operations. + Establishes tracking procedures for projects under minimal direction of manager . + Maintains and updates project tracking tools, metrics, and computer ... to Essential Regulatory Document Guidelines and Trial Master File ( TMF ) Plan and conducts preliminary review of essential regulatory...+ Performs quality reviews under the direction of a manager as required, including but not limited to review… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... Daiichi Sankyo Clinical Study Oversight Plan (CSOP). **Responsibilities** - Reconcile the TMF document trackers generated by the CRO with the document archive. Bring… more
- Pfizer (Cambridge, MA)
- …with high quality and within the approved budget. + Experienced project manager and matrix leader accountable for leading and overseeing internal and CRO/Vendor ... of study documents from Pfizer to the CRO/ Vendor Trial Master File ( TMF ) and final TMF transfer to the Pfizer Ignite Partner. + Ensures necessary Pfizer systems… more
- Vera Therapeutics (Brisbane, CA)
- …meeting agendas/minutes, review of CRO meeting minutes, etc.) * File study documents to the TMF , and assist in TMF review * Interacts with other departments as ... agencies, and staffing companies) are prohibited from contacting our hiring manager (s), executive team members, or employees. We require that all recruiters… more
- J&J Family of Companies (Columbus, OH)
- …impact health for humanity. Learn more at https://www.jnj.com/. Reporting to the Manager , Clinical Research Associates, the person in this role is responsible for ... and external audits to ensure all essential clinical Trial Master File ( TMF ) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and… more