- Amicus Therapeutics (Marlow, OK)
- …to record and file certain safety data in trial-specific Trial Master Files ( TMF ). The Global Drug Safety (GDS) Specialist is responsible for the day-to-day ... activities associated with filing safety data in the electronic TMF for all company-sponsored studies and reconciling this data with other clinical trial… 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
- Intra-Cellular Therapies, Inc (New York, NY)
- …to join our company, in the Clinical Operations Department as a **Clinical Trial Manager /** **Senior Clinical Trial Manager ** who plays an important role in ... the clinical trial process. As the front-line manager for clinical studies, the CTM is responsible for...study plans (project management plan, monitoring plan, communications plan, TMF plan) for assigned clinical trials. + Leads site… 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
- Vera Therapeutics (Brisbane, CA)
- Title: Clinical Trial Manager Associate Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... suffering from immunological diseases. Position Summary: The Clinical Trial Manager Associate will report to the Senior Director, Clinical...a component of a routine clinical study such as TMF review * May conduct, with oversight, site evaluation,… 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 **Position Responsibilities** + ... 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. **Summary** The Manager External Data Management, is accountable for an end-to-end delivery of ... readiness of external data documentation filed/archived in Trial Master File ( TMF ) according to applicable Daiichi Sankyo and regulatory requirements. + Supports… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …your best self. Become a **maker of possible** with us. **The Sr. Clinical Project Manager will:** + Lead all aspects of the planning and execution of IVD clinical ... and maintain clinical study documents as part of the trial master file ( TMF ) + Interact with investigational sites, vendors, key opinion leaders (KOLs) and… more
- Bristol Myers Squibb (Princeton, NJ)
- …enact best practices with instruction + Provide regular and timely updates to manager /management as requested + Support development of Protocol and ICF documents / ... amendments + Conduct literature review. Support submission of clinical documents to TMF + Support development of site and CRA training materials + Review clinical… more
- Edwards Lifesciences (Irvine, CA)
- …the evidence needed to optimize patient outcomes. As the Clinical Operations Manager in Advanced Technology (AT), you'll be responsible for managing clinical related ... through management of performance metrics, to ensure effectiveness, LMS compliance, and TMF quality + Plan, oversee, and lead in the development of procedures… 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
- Liberty Latin America (San Juan, PR)
- …issues, + and meet delivery schedules by working with the Scrum Master/Technical Manager /Engineering Manager . **What do you need?** + Bachelor's or Master's ... industry experience preferred. + **Good to have:** + Knowledge TMF eTOM and SID framework aligned product development +...Scrum Product Owner (A-CSPO) + SAFe(R) 5 Product Owner/Product Manager (POPM) + Professional Scrum Product Owner (PSPO) +… 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
- Actalent (Bethesda, MD)
- …* Ensuring that study Trial Master File is maintained and up to date and manages TMF audits as needed * Writes and updates SOPs * Prepares for and participates in ... third-party audits and regulatory inspections * Complies with ICH GCP guidelines, FDA regulations, and company SOPs * Manages and resolves conflicting priorities to deliver on commitments * Performs additional duties as assigned. Qualifications * Minimum BS/BA… 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
- 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
- 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 ... study conduct activities, including: drafting ICF study specific template and TMF plan, approving study-specific essential documents list, managing and communicating… 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