- Actalent (Boston, MA)
- …sections for investigator's brochures and other regulatory documents, as required * Ensure clinical trial master file for assigned trials are being updated by ... is hiring a permanent role (REMOTE) of a Delivery Manager for Clinical Operations with FSP experience....the development of all study related plans necessary for trial conduct * Develop project timelines to meet department… more
- Beth Israel Lahey Health (Boston, MA)
- …for vacations and/or vacancies. 7. Assists in the responsibilities for all clinical trial reporting requirements: Serious Adverse Events (SAEs), Deviations, ... in people's lives.** Job Summary: Reporting to the Program Manager (PM) the Clinical Trials Lead-CCTO (CTL)...reviews to the IRB.( 4. Monitors strict adherence to data management requirements by clinical research staff.… more
- Takeda Pharmaceuticals (Boston, MA)
- …to regulatory authorities. Further, the DVE team's efforts enable valid secondary use of clinical trial data throughout Takeda research groups to maximize ... empower you to shine? Join us as a Senior Manager , Clinical Data Visualization Engineer...integrating, execution, build and oversight of clinical trial deliverables. As part of CDE, the Data… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** Objective / Purpose: The Senior Manager Clinical Data Management is responsible for timely and high ... of Work, maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management provides...management activities are conducted within Takeda, leads and manages clinical trial data collection set-up,… more
- Bristol Myers Squibb (Cambridge, MA)
- …development projects + Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned ... their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager , Clinical Data Management (...functional study team members to ensure on-going review of trial data currency , quality and completeness… more
- Dana-Farber Cancer Institute (Boston, MA)
- … Research Manager is responsible for tracking and complying with clinical trial performance benchmarks; eg protocol and regulatory compliance, patient ... The ** Clinical Research Manager (CRM)** works within...electronic regulatory binders. Will maintain per DFCI CTO standards. ** DATA MANAGEMENT & CLINICAL TRIAL … more
- Dana-Farber Cancer Institute (Boston, MA)
- …from paper to electronic regulatory binders. Will maintain per DFCI CTO standards. ** DATA MANAGEMENT & CLINICAL TRIAL MONITORING** + Assumes responsibilities ... The Clinical Research Manager (CRM) will work...process, cancer treatment modalities, and the clinical trial process. + Experience in protocol development, data… more
- Astrix Technology (Boston, MA)
- …or nursing. + 10-12 years of professional experience, including at least 3 years as a Clinical Trial Manager (CTM) or Clinical Trial Project ... **Senior Clinical Project Manager ** Clinical ...budgets, and timeline management. + Familiarity with Medidata RAVE, clinical trial management systems, and Excel. We… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Clinical Research Manager with the oversight of their disease group's clinical trial portfolio and all related regulatory and compliance requirements. + ... Program at Dana-Farber Cancer Institute is seeking an **Assistant Clinical Research Manager ** to join our program....team to be maintain an "audit ready" research environment ** Data Management & Clinical Trial … more
- Dana-Farber Cancer Institute (Brookline, MA)
- …to interpret protocol activity schedules for research trial budget billing. The manager works closely with the Clinical Research Finance to prepare, review, ... The Clinical Trials and Transplant Billing Manager ... trials and transplant billing. This position collaborates with Clinical Trial Principal Investigators (PIs), Business Managers,… more
- Beth Israel Lahey Health (Boston, MA)
- …just taking a job, you're making a difference in people's lives.** The Clinical Research Program Manager is responsible for the administration and coordination ... of the PRECiSE study, a multicenter PCORI funded trial of pregnancy outcomes in Day 3 versus Day...fertilization. This role will oversee the operations of the Clinical Coordinating Center. Responsibilities include development and maintenance of… more
- Takeda Pharmaceuticals (Boston, MA)
- … study management/oversight, including significant study management support experience (eg clinical trial assistant/associate or lead CRA). + Experience could ... and empower you to shine? Join us as a Clinical Operations Manager based remotely reporting to...implementation of appropriate mitigation strategies. + In partnership with data management, review and pressure test all database timelines… more
- Novo Nordisk (Lexington, MA)
- …Internal relationships include data scientists, epidemiologists, leaders and specialists across Data Science, clinical trial teams, legal, compliance, IT ... medicines for patients. The Position The Strategic Real World Data Manager will be an integral part... trial designs + Other types of non-interventional clinical studies leveraging both retrospective and prospective data… more
- Avania (Marlborough, MA)
- Avania are hiring Data Analyst / Data Manager ...data visualization dashboards (SAS, Power BI) and other trial data analytics + Take part in client ... young, global and fast-growing team within Avania to support Clinical Trials in the MedTech industry? The Data...a Data Analyst (commonly referred to as Data Manager in CRO industry), your role… more
- Beth Israel Lahey Health (Boston, MA)
- … entry, and laboratory work. This position's focus will be with clinical trial sample processing, tracking, and shipment and data entry. This position may ... manage and coordinate clinical research protocols, as directed by the Program Manager or Principal Investigator (PI). The CRC will also have the opportunity to… more
- Takeda Pharmaceuticals (Boston, MA)
- …qualifications: + Knowledge of drug development, clinical study design, trial simulations, analysis methodology and data interpretation. + Innovative ... ICH regulations and industry standards applicable to study design, data analysis of clinical trials and regulatory...+ Specialized statistical expertise in multiple therapeutic areas or clinical trial development phases. (Experience in GI… more
- Pfizer (Cambridge, MA)
- …and experience managing pharmaceutical clinical and scientific data including clinical trial data + Understands and uses analytical skills/tools to ... **ROLE SUMMARY** Technology impacts everything we do. Pfizer's digital and ' data first' strategy focuses on implementing impactful and innovative technology… more
- Takeda Pharmaceuticals (Boston, MA)
- …of export and import compliance policies and procedures for the organization regarding Clinical Trial Material (CTM) and raw material shipments. + Manage daily ... Ensure adherence to country specific standard operating procedures for importing/exporting clinical trial material and raw materials, including logistics,… more
- Takeda Pharmaceuticals (Boston, MA)
- …programming + Demonstrates advanced knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations + Leads and ... eg R, Python. + Advanced knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations **Leadership:** + Demonstrated… more
- Takeda Pharmaceuticals (Boston, MA)
- … Pharmacology, Clinical Operations, Procurement, R&D and IT Quality, and Clinical Data Solutions to support clinical bioanalytical and biomarker ... logistics with external vendors thereby helping create high quality clinical data . **How you will** **contribute:** +...8 **+** years experience + Knowledge of drug development, clinical trial principles and understanding of the… more