Job Purpose/ Summary. Responsible for publishing submission documents to FDA specifications in eCTD format, building submissions in the eCTD software, completing submission to regulatory authorities, quality checking documents authored by CTI or others, and other tasks as required. Under the direction of the Manager / Senior Manager / Director, Regulatory & Scientific Affairs. . What You'll Do. Electronic document publishing of all modules with a...
Job Purpose/ Summary. Independently manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with, assist, and advise study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of ...
Job Purpose/ Summary. Responsible for overall global strategies and operational aspects of Regulatory Affairs Study Start-up (RASSU) department at CTI. Provides leadership and direction to all members of global RASSU, ensuring timelines, budget, and quality measures are met. Creates and fosters a collaborative work environment, attracting / mentoring high-performing team members. This position is open to candidates globally. . What You'll Do. M...
JOB PURPOSE / SUMMARY. This person will serve as the primary CTI Clinical Data Management (CDM) contact with sponsors and represent the DM group on CTI project teams. Responsible for study-specific CDM document development and maintenance, project status to the CTI project team, CDM management, and sponsors. Also, they are responsible for the data cleaning process from start-up through data archival, developing and/or approving project database ...
What You'll Do. Drive growth of the hematology/oncology/cell and gene therapy portfolio through medical and clinical development expertise and by providing medical oversight of awarded clinical trials. Participate in the lifecycle of CTI’s work from early engagement to clinical consulting to RFP and bid defenses to clinical trial execution and delivery. Accountable for medical oversight and management of awarded studies, including protocol review...
. JOB SUMMARY. The Information Technology (IT) Support Specialist I provides first-level use support to CTI Employees and sets up and maintains all phone and computer equipment. What You'll Do. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Provide first-level support to all CTI employees for computer system hardware, software, and telecommunications. Procure and install all new elect...
Job Summary. The Associate Director provides leadership role in facilitating the management of the multiple Phase I-IV clinical research trials across all geographic and functional areas. Responsible for ensuring that direct reports and assigned clinical operation's team members deliver their projects on time, on budget and with an acceptable level of quality. Work with assigned Clinical Project Manager (CPM) and functional leadership to ensure s...
Candidates will have specialized training and experience in any of the following disciplines: allergy/immunology, cardiovascular, endocrine, gastroenterology, infectious diseases, internal medicine, nephrology, neurology, or pulmonary diseases. Candidates with training in other disciplines are also eligible. Candidates with training and experience in, in cross-cutting disciplines, such as cell and gene therapy, rare diseases, pediatrics, and gene...
This position is responsible for selling CTI clinical trial and regulatory and scientific affairs consulting services, including Phase I-III clinical trials and regulatory consulting services spanning pre-IND to NDA support offerings. As part of this role you will be responsible for identifying, contacting and cultivating new clients and serving as client manager for existing clients. In addition to the duties and responsibilities outlined in the...
Job Purpose/ Summary. The Clinical Project Manager II (CPM II) is responsible for management and oversight of assigned clinical research trials (Phase I through Phase IV) to ensure client’s goals of time, cost, and quality performance are met. The CPM II is expected to perform most tasks independently but still requires support and guidance of the trial assigned Director and/or advanced Clinical Project Management (CPM) staff to ensure successful...
What You'll Do. Perform moderate and high complexity testing, as defined by CLIA, while following the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of test results. Stay current on and adhere to all laboratory policies and procedures. Properly document all deviations and/or corrective actions taken per laboratory policy. Demonstrate competency at least annually as outlined by labora...
Job Purpose Summary. Work with clinical research coordinators and investigators to preform appropriate clinical assessments for clinical trials (e.g., clinical safety labs, vital signs, ECGs, PK, etc.) from pre-study planning through successful completion of all subject visits and documentation. What you'll do. Responsible for the collection, processing and shipment of laboratory samples in accordance with site Standard of Procedures (SOPs), Clin...
