- Pfizer (Cambridge, MA)
- ROLE SUMMARY The Clinical Trial Transparency and Disclosure Manager ( Senior Manager ) is an integral member of the Medical Writing department. The ... requirements include, but are not limited to, EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information Guidance,… more
- J&J Family of Companies (Boston, MA)
- Senior Local Trial Manager -...management responsibilities and may also perform the role of Clinical Trial Manager (CTM)/Global Trial ... & Johnson's Family of Companies, is recruiting for a Senior Local Trial Manager -...feasibility assessment in conjunction with the Clinical Trial Assistant (CTA) (if applicable), Site Manager … more
- Merck (Boston, MA)
- …and oversight for programs identified as critical to the success of Global Clinical Trial Operations (GCTO), Global Clinical Development (GCD) objectives ... **Job Description** **Position Description:** **Supplier Manager ** The Supplier Manager key responsibility...should also provide operational leadership and guidance to Global Clinical Trial Operations (GCTO), Global Clinical… more
- Novo Nordisk (Lexington, MA)
- …development experience in the pharmaceutical industry + At least 3-5 years of experience as a Clinical Trial Manager + Experience with global clinical ... patients. The Position We are looking to hire a Senior Clinical Project Manager (CPM).... CPM will be responsible for all aspects of clinical trial management aimed at treating a… more
- Merck (Boston, MA)
- …serves as the GCS spokesperson at clinical development related meetings (ie, Clinical Trial Teams) and product development related meetings. The incumbent is ... and maintain patient continuity of supply. Working independently, the Clinical Supplies Project Manager (CSPM) designs strategic...to:** + Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates closely… more
- Bristol Myers Squibb (Cambridge, MA)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Clinical Scientist reports through the Clinical Science function ... + Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical... narratives + Provision of information required by Protocol Manager for development of trial budget, CRO… more
- Bristol Myers Squibb (Cambridge, MA)
- …to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key Responsibilities** + ... within the asset and/or indication + Responsible for managing clinical trial physician(s); attracting, developing and retaining... clinical trials (eg significant experience as a senior clinical leader), and exhibits all of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Senior Manager , Clinical Data Management in Lexington, MA with the ... Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical ) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead… more
- WuXi AppTec (Natick, MA)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... control functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and WuXi Clinical Standard Operating… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** Senior Manager , Feasibility Are you looking for a patient-focused, innovation-driven ... and empower you to shine? Join us as a Senior Manager , Feasibility based Cambridge, MA or...disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform… more
- Merck (Boston, MA)
- …preparation of status update reports, study closeout activities). May serve as the clinical trial team (CTT) lead. Leads team for timeline management, risk ... **Job Description** Our Clinical Research and Pharmacovigilance team push the boundaries...criteria with cross-functional team. + Works closely with Global Trial Optimization (GTO) to: develop patient recruitment and retention… more
- Bristol Myers Squibb (Cambridge, MA)
- …to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Position Responsibilities** + ... within the asset and/or indication + Responsible for managing clinical trial physician(s); attracting, developing and retaining...clinical trials having had significant experience as a senior clinical leader and exhibits all of… more
- Sanofi Group (Cambridge, MA)
- …approved therapies and when they are not eligible to participate in a clinical trial . Cross-GBU Pre-Registration Import License (PRIL) is designed to oversee ... to patients with specific illnesses where treatment access is limited. **Global Senior Manager - Governance & Risk Management** sits within Specialty Care MAP… more
- Merck (Boston, MA)
- …The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed ... Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible...Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT). + Collectively and… more
- Pfizer (Cambridge, MA)
- …+ Experience in understanding of key drivers impacting budgets and experience building a Clinical Trial Budget and managing project to budget. + Experience in ... of relevant experience. + **PREFERRED QUALIFICATIONS** + Broad experience in a Clinical Study Execution discipline (eg, senior study management expertise, lead… more
- Medtronic (Boston, MA)
- …RESPONSIBILITIES:** The following responsibilities are to be performed as appropriate in clinical trial case support and/or case support following commercial ... wave forms, and ancillary procedural solutions + Knowledge of Clinical trial protocols, and CoreValve and other...information regarding product price or account activity to District Manager and other appropriate company personnel + Ensure a… more
- Beth Israel Lahey Health (Charlestown, MA)
- …limited to** : 1) Prepares, maintains and monitors budgets relating to each active clinical trial and / or research grant. 2) Develops, maintains and publishes ... during rate Under general supervision of the Decision Support Manager the Senior Decision Support Analyst preforms...in writing quarterly reports on the financial status of clinical trials and grants. 9) Audit database integrity by… more
- Medtronic (Boston, MA)
- …+ Knowledge and experience with GCP, GLP and QMS + Expertise in pre- clinical studies, clinical trial design, project management, and negotiations ... need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team for Medtronic's… more
- Editas Medicine (Cambridge, MA)
- …key program and study metrics + Ensure ongoing medical monitoring and oversight of clinical trial data, external clinical data collection + Provide strategic ... The incumbent is expected to be a strong people manager and be willing to 'roll up the sleeves'...clinical programs. + Ability to work with the Senior Executive Team and other external audiences such KOLs,… more
- Takeda Pharmaceuticals (Boston, MA)
- …the needs of the business in a global setting. Solid understanding of the clinical trial process, including GCP, legal and budgeting requirements + Superior ... of my knowledge. **Job Description** **About the role:** The Global Category Manager - Post Approval is accountable for engagement with Global Category Management… more