- System One (Boston, MA)
- Title: Clinical Trial Lead Location: Boston, MA. Start Date: ASAP! Duration: Contract-to-Hire Hours: Mon-Fri; 8:30am-5pm Overview Our client is a hospital ... and Vascular. Requirements: - BS degree required - 2-3 yrs. of industry clinical trial experience from CRO, Pharma, Biotech or Healthcare setting is required. - … more
- Takeda Pharmaceuticals (Boston, MA)
- …ensure appropriate audit scopes and clinical trial delivery participation. + Lead clinical trial functional areas and study teams on issues related ... tools + Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA/EC-related… more
- Pfizer (Cambridge, MA)
- …use of consistent, efficient, and quality processes to meet timelines and deliverables. + Serve as Clinical Data Scientist and Trial Lead for one or more ... discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and...globe. **How You Will Achieve It** + Provide guidance, lead /co- lead projects, manage own time to meet… more
- Edwards Lifesciences (Boston, MA)
- … studies. **How you will make an impact:** + Act as core team member/ lead biostatistician of assigned clinical trial (s) in US and international/global ... exceeding the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead + FDA/EMEA/PMDA submission experience +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …knowledge. **Job Description** **_OBJECTIVES/PURPOSE_** As the Global Platform Manager for Clinical Trial Recruitment working in the Enterprise Medical Digital ... primary liaison across R&D, Medical Affairs, and Commercial in support of Takeda's Clinical Trial Recruitment Technologies. In this role, you will drive Takeda's… more
- Actalent (Boston, MA)
- Job Title: Senior Clinical Trial Manager Job Description We are seeking a dedicated and experienced Senior Clinical Trial Manager responsible for ... operations experience. + At least 5-6 years of Clinical Trial Management (CTM) experience. + Experience...+ Ability to run an entire study as the lead from start-up to closure and database lock activities.… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... The **Senior Clinical Study Lead ** (CSL) is expected to...Ensures compliance with the clinical trial registry requirements + Identifies outsourcing needs… more
- Pfizer (Cambridge, MA)
- … Trial Execution discipline (eg senior study management expertise, lead data management expertise, clinical leadership expertise) + Demonstrated project ... a lasting impact on society. **ROLE SUMMARY** As a Clinical Study Team Lead (CSTL), you will...Your project management skills will be leveraged to develop clinical trial timelines and oversee budgets for… more
- J&J Family of Companies (Danvers, MA)
- …of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation ... + Provide coaching and training to junior employees. + Lead in the investigation of all discrepancies in study...parameters of study hypothesis, as well as to monitor clinical trial /study safety, in keeping with protocols,… more
- Pfizer (Cambridge, MA)
- …of two in respiratory area. Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable. Good understanding of ... **ROLE SUMMARY** The purpose of the Senior Director of Clinical Research role is to coordinate and lead...* Sit on project teams from FIH/POM/SOCA through POC trial completion to ensure that clinical development… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Data Sciences team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. The Clinical Data Sciences group ... The CDE team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. As part of CDE, the Clinical … more
- Pfizer (Cambridge, MA)
- …responsible for providing support of scientific oversight, data integrity and quality of clinical trial (s) in support of the development strategy for programs ... lines for the successful implementation and execution of the clinical trial (s) within the assigned program. +...and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's… more
- Schrodinger (Cambridge, MA)
- …writing. The Director of Early Clinical Research will have experience in oncology clinical drug development, clinical trial design, and execution, with a ... with a strong background in oncology drug development and clinical trial design + A savvy relationship...Lead outreach and interactions with key opinion leaders, clinical investigators, and other key stakeholders to build relationships… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The Clinical Lead (CL), Internal Medicine RU (IMRU) will be the thought leader driving clinical research for the expanding area of metabolic ... and the highest ethical standards. He or she will lead clinical development strategy and program execution...with key clinical experts, academic entities, and clinical trial sites, and uses these relationships… more
- Sanofi Group (Cambridge, MA)
- …across the project or study teams + Raise study or project-level issues to the Clinical Lead and/or Project Head when needed + Contribute to the definition of ... + Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs...study, compound, protocol + TA Experts, senior CRDS, global clinical lead , GPHs and medical affairs +… more
- Sanofi Group (Cambridge, MA)
- …Medical Manager responsibilities eg: managing or contributing to the operational activities from clinical trial set-up to clinical study report in compliance ... expansion into several high prevalence/high impact diseases with multiple trial starts in the next 12 months. This includes...of the study risk management plan + Support the Clinical Lead and CRD to prepare presentations… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represents Clinical Science on the Global ... Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and… more
- Sanofi Group (Cambridge, MA)
- …for developing the clinical development plan, designing and executing clinical trials, analyzing trial data, interacting with regulatory agencies, and ... will work closely with the Global Project Head, Research Scientist, Clinical Pharmacologist, Biomarker Lead , Safety Medical Director, Statistician, Regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …strategy for the overall global (US/EU/Japan/ other regions and countries) clinical development for Specialty Care products, specifically focusing on development of ... will apply their expertise in Nephrology and/or Transplant medicine to clinical development, taking into consideration the medical, scientific, regulatory and… more
- Takeda Pharmaceuticals (Boston, MA)
- …and empower you to shine? Join us as a Senior Medical Director, Oncology Clinical Science in our Cambridge office. At Takeda, we are transforming the pharmaceutical ... Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and… more