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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 1 day ago
Ensure efficient study execution, including oversight of CROs, vendors and consultants that are involved with the clinical trial Responsible for oversight and project management of individual studies as assigned Offer advice related to study milestones and ensure accurate tracking and reporting of study metrics and timelines. Risk identification and mitigation efforts and
Posted 2 days ago
OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Scientist III 509796 in Remote or Ridgefield, CT (Hybrid). Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES Duties and responsibilities Apply advanced statistics and mach
Posted 4 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 4 days ago
Provide scientific expertise necessary to support the data quality and delivery of clinical studies and programs. Work directly with the Sr Director, Clinical Sciences to implement activities supporting clinical development plans for assigned program(s) including o Review, query, analyze, and interpret emerging clinical trial data o Present, review, and interpret the full
Posted 4 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 4 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 5 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 5 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 11 days ago
Develops scientific understanding of assigned program and protocol requirements Supports protocol design and development strategy for clinical trials Manages protocol development process; including writing support, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document Contributes to the development of Informed Consent Fo
Posted 18 days ago
Lead the development and implementation of submission ready SDTM datasets in accordance with regulatory requirements (e.g., FDA, EMA, PMDA). Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. Perform thorough quality control checks to validate the accuracy and completeness of submission datasets.
Posted 18 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 19 days ago
The Sr. CRA is responsible for assisting with the execution of high quality clinical studies and will focus on the oversight and monitoring of investigational sites to ensure compliance and assist with study management activities. The Senior CRA will be a key contributor to the company's clinical department and primarily responsible for the site management of assigned cli
Posted 22 days ago
Providing strategic leadership and demonstrating accountability for the clinical pharmacology programs supporting Phase 1 4 clinical development for development compounds Representing the department and providing subject matter expertise on cross functional project teams Developing and maintaining collaborative working relationship with colleagues within and outside the d
Posted 23 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 22 days ago
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