The Legal Analyst (Senior or Associate) is responsible for assisting in the coordination and documentation of activities associated with MedSource contracts including, but not limited to, corporate/commercial contract review and negotiation, project and document tracking, and database management. This individual will be expected to interact with MedSource staff and clients and will exercise appropriate professional […]
Provide Study Start-Up Specialist activities in support of assigned projects including IRB/IEC submissions, informed consent review, essential document collection and review in preparation of site initiation and activation. Provide leadership to junior department and project team members. DUTIES AND RESPONSIBILITIES: • Work closely with project teams to ensure efficient start-up processes for assigned projects in […]
The Clinical Team Lead is a position of responsibility within a project with the requirement to supervise one or more Clinical Research Associates (CRAs). As a high-profile role within the project, the CTL must be able to interact confidently with the client, maintaining a professional image when working under time constraints and act responsibly as […]
The Senior Clinical Research Associate (Sr. CRA) is responsible for interfacing with investigative sites to monitor the conduct and assess the progress of clinical research studies to ensure compliance with protocol(s) and applicable MedSource or Sponsor Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines, and any additional applicable regulations as required. With limited supervision, […]
The Associate Director, Study Start Up & Clinical Support Services manages the Study Start Up & Clinical Support Services staff to ensure successful execution of Study Start Up activities, including site feasibility, site identification, site activation, ongoing study support in all areas of administration, and ongoing collection and management of essential documents and Trial Master […]
Develops domestic and global proposal budget and text documents for strategic and complex proposals and/or rebids. Assists in the supervision and quality control (QC) of the proposal development process and delivery. Mentors and/or trains less experienced staff members. This individual will be expected to interact with staff and clients and will exercise judgment in all […]
The Clinical Operations Senior Project Manager (SPM) is responsible for the overall management of all phases of clinical trials utilizing MedSource or sponsor Standard Operating Procedures (SOPs) as applicable, FDA regulations, and ICH-GCP guidelines. The Senior PM possesses in-depth knowledge of and experience in the drug development process, including study start-up, initiation, clinical monitoring, drug […]
The Director of Business Development is the initial point of contact with potential customers and is responsible for presenting the professional image, capabilities, and competencies of MedSource, Inc. This individual is responsible for driving revenue, territory management, developing new business, retaining and expanding existing business and identifying client needs and sales solutions. Experience in developing […]
The Data Management, Project Manager (DMPM) has overall responsibility for the successful planning, execution, monitoring, control, and closure of multiple projects. These projects will be managed from initiation to close-out for data management and may include statistics and medical writing activities. Acting as the primary contact for the customer for all delivery activities, the DMPM […]
The Senior Biostatistician provides statistical input into Phase I – IV clinical trial development. Responsibilities include statistical input into protocol development (e.g., trial design, sample size estimation, randomization, statistical methods for protocols); developing statistical analysis plans (SAPs) and mock tables listing and figures (TLFs), statistical analysis, and writing detailed statistical analysis plans including specifications for […]