- ConvaTec (Lexington, MA)
- …our customers and each other. We're aiming for nothing short of excellence. Join us as a Clinical Study Manager (CSM) and you'll do the same. The Clinical ... clinical studies . As part of the Clinical Study Management pillar of Clinical...medicine, or related discipline. + Minimum of 2-3 years Clinical Research experience, preferably within medical device … more
- ThermoFisher Scientific (Tewksbury, MA)
- …the study planning, coordination, execution, and management phases. + Develop clinical study plans/reports for inclusion into the project Design History File ... (DHF). + Lead all aspects of clinical study execution on assigned projects, including...monitoring, and eTMF completion. + Facilitate internal and external clinical studies preparation and planning meetings. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Affairs to lead clinical strategy activities and oversee all aspects of clinical studies in support of clinical evidence generation strategies across ... the Respiratory business unit. + Oversees all aspects of Clinical Study Management within the Respiratory business...they propose reasonable mitigation strategies, which may involve future clinical studies . + Participates in strategic and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …for the clinical operations team including the oversight of all aspects of clinical studies in support of clinical evidence generation strategies across ... Contract Research Organizations (CROs), or other external vendors, in clinical studies and ensures management and oversight... Clinical Operations, with direct strategic experience in clinical study management for pre and post-market… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Director, Clinical Operations and collaborates closely with the leadership of Clinical Affairs to lead clinical studies project management within ... US region including the oversight of all aspects of clinical studies in support of clinical...sciences or related field + Minimum of 10 years device /pharmaceutical industry experience in Clinical Affairs/Operations with… more
- Novo Nordisk (Lexington, MA)
- …that impact dosage and dose setting including CMC, Device , Non-clin and clinical activities + Available and future studies that can support dose setting ... of trial is complete + Ensure scientific quality in data interpretation + Clinical Study Reports and publications + Internal and external presentation and… more
- Abbott (Burlington, MA)
- …work instructions and SOPs. This position will work closely with the cross-functional clinical study team including field clinical affairs, marketing, ... + Design and manage multiple digital platforms to track and communicate clinical study progress. + Synthesize and disseminate literature across multiple… more
- Takeda Pharmaceuticals (Lexington, MA)
- …used within a clinical development environment, and can contribute to clinical study design discussions. + Maintain current knowledge of applicable ... Description** About the role: Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where you will...minimum of 4 years' experience in drug, biologic or device Regulatory Affairs or related field, including a minimum… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Clinical Affairs in the conception, development, and implementation of impactful clinical investigations to arrive at relevant study designs by providing ... board-certified, fellowship trained gastroenterologist proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the differentiated value of our technologies. + Provide strategic input into clinical trial design for relevant endpoint selection: eg economic, humanistic, in ... addressing purchasers, payers and policy makers + Coordinate with Medical & Clinical Affairs, Regulatory to ensure appropriate support and guidance when addressing… more