Independently perform the following responsibilities under the direction of the Product Development Manager and/or Program Head to coordinate, manage, and lead the overall execution of clinical studies or group of clinical studies while following appropriate GCPs and SOPs Provide scientific insight into study design and disease process; Lead protocol development and writi

Independently perform the following responsibilities under the direction of the Product Development Manager and/or Program Head to coordinate, manage, and lead the overall execution of clinical studies or group of clinical studies while following appropriate GCPs and SOPs Provide scientific insight into study design and disease process; Lead protocol development and writi

OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Medical Director/Clinical Trial Physician remotely. The Clinical Trial Physician will play a key role in a large global phase 3 lupus outcome study. In addition to the responsibilities described below, the CTP will be specifically responsible for reviewing participants me

Serves as the Regulatory Affairs lead on cross functional MDR project teams Ensures compliance with EU Medical Device Regulations (MDR) and EU guidance throughout the project. Actively participates in EU MDR project teams by attending meetings, collaborating with the project manager and cross functional team members, and communicating regulatory requirements and guidance

Lead and support the qualification and evaluation process for new service providers. Lead with minimal supervision the process of Request for Proposal (RFP) development from service provider selection through final contract execution. Manage the contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, C

OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Regulatory Specialist in Des Plaines, IL. The Regulatory Specialist role will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES Responsible for implementing and maintaining the effectiven

OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a QC Technician III in Saint Joseph, MO. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES Performs bio analytical methods (Chemistry lab) for various Bio QC Tests on raw ma

Execute surface plasmon resonance (SPR) analysis for small molecules binding to protein and/or protein interactions. Work both independently and as part of a team to ensure project team goals and deliverables are met. Communicate effectively and present results in cross functional team meetings Trouble shoot and solve scientific problems with minimal supervision. Be highl

Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team. Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials Provide direction and leadership in CRO and vendor selection and management. Knowledge of regulatory start up process and planning in support of study start up Managing and maintai

OVERVIEW We are currently searching for a skilled professional to join a well known client's team in the role of Sample Management Lab Project Manager. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. MAIN RESPONSIBILITIES AND ACCOUNTABILITIES Responsible for the planning, oversight of test

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

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.

Participate in study start up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit) Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation

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

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