Ensure clinical trials are conducted in compliance with protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries and sites Ensure subject safety and verify diligence in protecting the confidentiality and wellbeing of study subjects Verify adequacy, completeness, reliability, and quality of trial data collected at stud

OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Process Technician in Exton, PA. Under supervision and guidance, the Process Technician of Upstream Operations will be responsible for hand on executing the routine operation, maintenance, and periodically requalification of cell culture based upstream production equipmen

The Manager, Data Management is responsible for managing all aspects of data management activities and assigned direct reports to ensure all time frames and targets are met. The Manager, Data Management may serve as portfolio level oversight or as Biometrics Project Manager for data management and biostatistics stand alone programs. Responsibilities Onboarding of new empl

The Senior Grants and Contracts Manager works under limited supervision and guidance of management. This position is primarily responsible for creating, collaborating and negotiating investigator budgets and contracts. Responsibilities Maintains a flexible approach to address issues innovatively and proactively. Provides the Business Development and Proposal teams with gr

OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Regulatory Affairs Associate in Abbott Park, IL. As a professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Their work will have a direct i

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 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

Executes fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multi product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Executes independently with adequate training non complex fundamental operations as parts cleaning, weigh and dispense,

OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Medical Safety Reviewer in Columbus, Ohio. The Medical Safety Reviewer role will support the medical safety team by collecting, assessing, processing adverse events for clinical or post marketed products in compliance with applicable regulations, guidelines, researching,

Independently negotiates initial or amended site Clinical Trial Agreements (CTAs) and budgets, and/or serves as escalation point and oversight for CROs negotiating site CTAs and budgets in support of assigned global Clinical Studies. Independently negotiates other initial or amended clinical Agreements such as Investigator Initiated Research Agreements (IIRs), Confidentia

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

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