OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Global Regulatory Affairs Strategist remotely. The Global Regulatory Affairs Strategist will be the regulatory representative for assigned due diligences, under the direction of the Global Regulatory Strategy Lead (GRSL). An external company and assets or individual asset

30% Lead cross functional team in a matrix environment Independently lead projects with limited direction Must be able to Influence others beyond their scope and level 20% Develop and manage project plans and schedules Utilization of tools to identify, manage and communicate processes and risk Drive team accountability for deliverables and ensure projects meet milestones.

Follow Standard Operating Procedures (SOPs) Maintain long term client relationships resulting in the expansion of client base. Directly implement initiatives to help build awareness of our company capabilities and services. Uncover immediate needs of target market through leads and follow ups, executing internal and external initiatives to drive profitable growth. Utilize

Contribute to writing and reviewing of study related documents such as protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documents Experience with single case unblinding Knowledge with early development activities and documents Contribute to writing and reviewing medical monitoring plans and other

The Senior Biostatistician will have experience in all required areas as a Biostatistician II. The Senior Biostatistician is responsible for serving as a study lead. They will apply strong statistical expertise to provide statistical support for clinical trials. This includes generating randomization schedules, participating in protocol development, authoring the SAP, pre

Assist Associate Director and senior leadership in the management of the outsourcing, vendor selection and clinical contracts process Generate RFIs, RFPs, and contract templates Assist Clinical Trial Managers with quarterly internal budget forecasts of clinical projects Assist Associate Director with costing trials for internal planning purposes Negotiate and maintain cli

OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Scientist III in Ridgefield, CT. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES As an active team member of the Computational Biology (CompBio) research group, the succ

Daily support and problem solving in line with Safety, Quality, Delivery, and Productivity objectives Development, incorporation of, and maintenance/calibration of fixtures, tooling, and gages Assists in the development of product and manufacturing specifications for new and existing products. Assists in initiating and processing engineering change documents and drawings.

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

Design and implement the functional Medical Affairs strategy plan, oversee IIS and expanded access programs, lead publication strategy, lead the writing of selected publications and Grant applications. Oversee the Strategy plan and implementation of scientifically sound Investigator Initiated Studies, manage publication planning and execution to ensure that all data gener

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

OVERVIEW We are currently searching for a skilled professional to join a well known client's team as an Occupational Health Nurse in Plymouth, MN. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES Provide occupational health services including treatment and care to site pop

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

Develop a robust timeline and plan for the overall program. Development or improvement of program processes to drive program efficiency Update program trackers and program update reports Assist with PMO deliverables for program health improvement initiative Take on project management remediation process which includes coordinating with program workstream leaders to manage

Responsible for the management of assigned clinical trial(s) and the physician training events by leading cross functional teams that may include tasks specific to study start up, regulatory, contract and budgeting, safety, medical monitoring, training event planning, etc. Serves as the clinical trial/project point of contact and the liaison with the CRO, third party vend