Clinical Trial Manager VaxInnate
Responsible for implementation and management of clinical research studies; ensures regulatory and scientific integrity of projects. Evaluates monitors and documents all study parameters. Proficient in Good Clinical Practices (GCP).
Main Job Tasks and Responsibilities Include:
? Assists in the designing, planning, implementation and management of clinical research projects
? Responsible for management of Clinical Research Organizations (CROs) and other vendor maintaining relationships and assessing performance
? Resolve patient eligibility and protocol deviation issues
? Supervises data collection and formulation
? Contributes to the preparation of clinical trials and amendments including selection of principal advisors and thought leaders
? Assists in writing clinical study protocols, informed consent documents and clinical study reports.
? Coordinates with manufacturing for packaging/forecasting of investigational product
? Prepare clinical outsourcing specifications for requests for proposals (RFP?s)
? Design Diary Cards, Case Report Forms (CRF?s), monitoring plans, and study guides for clinical studies
? Participate in meetings with Biomedical Advanced Research and Development Authority (BARDA), National Institutes of Health (NIH) and/or other funding sources
? Oversight of project specific clinical budgets and ongoing payments
? Delivery of presentations to investigators, management and consultants as required
? Assists in writing clinical sections of INDs, BLAs and annual IND reports
? Organize advisory meetings, investigator meetings
? Identify, recruit and approve clinical investigators
? Maintains or supervises ongoing contact with Investigators and staff to ensure compliance
? Coordinate safety reporting to study sites, Data Safety and Monitoring Boards, and Center for Biologics Evaluation and Research (CBER)
? Monitoring of clinical sites as needed
? BA/BS degree
? Minimum of 7 years clinical research experience; pharmaceutical, biotechnology or CRO. Extensive experience in the conduct of clinical trials of varied design and complexity.
? Demonstrated ability to use scientific knowledge to conceptualize clinical study design with minimal guidance.
? Understand clinical development processes form IND submission through Phase 3 studies
? Ability to communicate cross-functionally with supporting departments in the organization, i.e. research Quality Assurance (QA) , Quality Control (QC), regulatory affairs, and process development
? Proficiency in clinical studies involving complex design issues (i.e., multiple arms, crossover, double blind, multi-center), typically acquired with experience in all phases of pre-approval clinical trials
? Experience in management of multinational clinical trials
? Demonstrated strong leadership skills
? Detailed knowledge of regulations and guidelines, coupled with experience, judgment and ability to anticipate and resolve problems
? Demonstrated ability to write clearly and effectively present ideas (both written and oral), good communications skills including appropriate usage of medical/scientific terminology
? Demonstrates interpersonal, organizational and planning skills
? Proficiency in independently developing budgets and overseeing expenditures
? Demonstrates successful external collaboration skills, such as efficient management of CRO and other outside vendors
? Demonstrated ability to maintain a constructive problem-solving attitude while dealing with time demands, incomplete information or unexpected events
? Familiar with advanced concepts of clinical research
? Typically 20-30% of time worked, and as needed for professional meetings, site initiation visits, investigator meetings, expert panel meetings, etc.
||Three Cedar Brook Drive |
Cranbury, NJ 08512