Clinical Trials Manager

The Clinical Trials Manager (CTM) will manage the research program for the Autoimmune and Cholestatic Liver Disease Program at Yale. The CTM will manage multiple principal investigators and potentially multiple other sites for collaborative research, and will manage all aspects of this clinical trials program, which may include collaborating in the development of the research protocols required for study. This position will foster and maintain relationships with all investigators and faculty involved in this clinical trials program, and is responsible for outreach efforts, compiling, analyzing and reporting data to sponsors, and the administration, organization and execution of all clinical research. Job Summary: Participates in the design, administration, and monitoring of clinical trials. Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives. Manages various aspects of research projects, including patient recruitment, data collection, and ensuring adherence to regulatory standards. Provides team support on research projects, ensuring meticulous data management, and assisting in the preparation of reports and publications. Time Type: Full time. Duration Type: Staff. Work Model: On-site.

Responsibilities

Manage the research program for the Autoimmune and Cholestatic Liver Disease Program at Yale; Manage multiple principal investigators and potentially multiple other sites for collaborative research; Foster and maintain relationships with all investigators and faculty involved in the clinical trials program; Conduct outreach efforts to expand referrals of new patients for tertiary patient care and participation in studies on a regional and national level; Compile, analyze, and report data to sponsors on a regular basis; Build a budget by researching similar trials and contacting appropriate sources for additional data; Create original HIC and IRB submissions; Collaborate with principal investigators on the creation and maintenance of scientific protocols and implement protocol changes; Design and implement quality control measures to ensure accurate data collection; Carry out research within the scope of the established study protocol and adhere to human subjects regulations; Develop criteria for admission of study subjects; Determine potential sources of funding and prospective partnerships; Evaluate feasibility of accepting potential projects and negotiate contracts and/or changes with funders; Develop forms, questionnaires, research techniques, and procedures manuals for data collection and coding; Document and transmit study data and ensure report forms are completed in a timely manner at each site; Work independently to develop, manage, and organize multi-site studies and serve as primary coordinator between University, non-Yale collaborators, pharmaceutical companies, HIC, IRB, and funding sources; Perform descriptive and multivariate statistical analyses of data using computer software; Contribute original scientific thought to written reports, abstracts, manuscripts, and publications

Requirements

Excellent written and verbal communication skills, with strong attention to detail; Proven experience conducting and supporting all phases of clinical research, including data management and analysis; Phlebotomy; Strong organizational skills, with the ability to multitask, prioritize tasks, and manage time effectively across multiple clinical trials; Proven experience with participant interaction, IRB submissions, and initiation and maintenance of human research studies and ability to work both independently and as part of a multidisciplinary team; Proficiency in Microsoft Office Suite and experience with electronic data collection tools; Master's Degree in a related discipline and two years of experience or an equivalent combination of education and experience

Nice to have

Master's degree in a related field (e.g., public health, social sciences); Proven experience preparing IRB protocols, amendments, and progress reports; Proven experience with clinical trials, including patient recruitment and regulatory submissions; Familiarity with statistical analysis software (e.g., SPSS, SAS, R); Prior experience working on large-scale research studies or multi-visit projects

Benefits

General description of benefits available at Yale Benefits