- Parexel (Lansing, MI)
- …for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies , in compliance with Client Procedural Documents, international ... **CRA and Sr CRA positions- Remote - Need for SE Region - FL**...escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance… more
- Parexel (Lansing, MI)
- …for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies , in compliance with Client Procedural Documents, international ... (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant...escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance… more
- Parexel (Lansing, MI)
- …Study Operations Manager (SOM) + When required Partners with other Study Team members (eg Clinician, Recruitment Specialist, Clinical Data Scientist) + ... + Demonstrated knowledge in disease and technical areas pertaining to clinical studies , including knowledge of company direction, investigational product(s),… more
- Parexel (Lansing, MI)
- …champion, etc.). **Skills:** + Strong understanding of the different operational aspects of clinical study conducts in different regions across the world, which ... **Homebased US** As a Proposal Manager with Parexel you are in a client...(RFP) process + Receives and analyzes RFP documentation including study protocol or synopsis and ensures all appropriate Subject… more
- Parexel (Lansing, MI)
- …champion, etc.). **Skills:** + Strong understanding of the different operational aspects of clinical study conducts in different regions across the world, which ... **US Homebased** A Contracts Manager with Parexel is a client facing role...or equivalent combination of education and experience. MBA preferred. \#LI- REMOTE EEO Disclaimer Parexel is an equal opportunity employer.… more
- Parexel (Lansing, MI)
- …assigned project/ study . + Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), ... Supporting Activities - Medical Support / Medical Monitoring for projects and studies contracted to Parexel - Deliver all medical support required for successful… more
- Parexel (Lansing, MI)
- …management activities **CSR Narratives (as applicable)** + Performing medical review of Clinical study report narratives according to the client's guidelines and ... and sign off adverse events report for accuracy and clinical importance, relationship to the study drug...processing cycle + Provide input as necessary to Feasibility Studies , Data Monitoring Committees (DMCs), Clinical Endpoint… more
- Parexel (Lansing, MI)
- …practice + Interact with clients and regulatory authorities + Review publications and clinical study reports + Travel to, attend, and actively contribute to ... discussing study results) + Additional responsibilities as defined by supervisor/ manager . **Skills:** + Good analytical skills + Good project management skills +… more
- Parexel (Lansing, MI)
- …investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical ... /scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or… more
- Parexel (Lansing, MI)
- …Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead ... providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to… more
