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Work with the Global and US regulatory & commercial team to support pipeline advancement, on market strategy/execution and FDA approval and post marketing commitments for parenteral nutrition (PN) products, providing medical / scientific support. Mentor, manage, and ensure development of the PN Medical Affairs Team. Lead team to support medical content development and rev
Posted 3 days ago
Conduct site qualification, initiation, remote and interim monitoring and study closeout visits for pediatric and adult nutrition and Phase 1 4 studies in accordance with the protocols, federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Company Standard Operating Procedures (SOPs) and business processes. Set up study site management in Clinical Trial
Posted 6 days ago
A Lead Clinical Research Associate (Lead CRA) is responsible for Conducting monitoring activities at assigned clinical trial site(s) Verifying the adequacy, reliability, and quality of data collected at clinical sites Supporting Clinical Trial Leads (CTL) in the clinical trial execution by ensuring CRA and site oversight and Monitoring Plan compliance Overseeing CRAs and
Posted 6 days ago
Collaborates with multiple stakeholders and leaders across functions of relevant departments and additional eTMF users, as required to develop strategy for the study TMF, provides input to study risk assessment and vendor selection. Provides an advanced level of knowledge to cross functional TMF business representatives and/or Business Partners in TMF issue resolution. Dr
Posted 7 days ago
Serves as the eISF process owner and Subject Matter Expert (SME) for study teams and sites Develops Work Instructions and guidance documents for study teams and sites, focusing on increased efficiency and quality of deliverables Provides real time support and follow up to sites, as needed, to ensure contemporaneous filing and completeness Assists with the development of e
Posted 7 days ago
We are currently searching for a skilled professional to join a well known client's team as a remote Central Services Specialist. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. Under the guidance of Global Clinical Study Support ("CSS") management, this position will be responsible for p
Posted 13 days ago
Support for global pharmacovigilance of assigned products as needed, including the review and analysis of safety data from clinical studies, the post marketing setting, and the scientific literature; assistance with signal assessments; assistance with the preparation and review of aggregate reports, core documents, and labelling updates as required; assistance with the pr
Posted 21 days ago
Provide quality leadership and direction to Sponsor's R&D stakeholders on GCP related activities/issues and act as GCP expert/consultant for R&D colleagues. Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas. Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as need
Posted 24 days ago
Drive sales pipeline for Endoscope Repair and full repair catalog. Grow and retain existing accounts by presenting new solutions, products and services. Prepare and or participate in larger customer or IDN visit presentations. Develop target lists of potential accounts in cooperation with the sales reps. Active role working directly with Sales Leaders to execute overall k
Posted 24 days ago
Under the direction and as requested by the the sponsor CPMs, the Contracts and Grants Manager may Assists with the development of Investigator/Institution contracts and site budgets Provides investigator grant estimates for RFPs, upon request Supports site budget negotiations and payment terms as needed Provides strategic insights in the development and negotiation of si
Posted 25 days ago
Trial Start Up Group Accountable for advancing study start up activities for outsourced trials by understanding the objectives and assisting in the review and approval of the plan for country and site activation. Laser focus approach to oversight of start up activities within our CRO assigned programs. Working with the CRO partners to maintain timelines and successful exe
Posted 25 days ago
The Senior Director, Business Development, effectively identifies and pursues new and existing business opportunities while enhancing relationships with existing clients, keeps abreast of industry trends, competitors' services and acquisitions, and works in conjunction with leadership to develop and respond to new and existing business development opportunities. The Senio
Posted 1 month ago
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