Clinical Trial Manager - Independent Contractor
Clinical Trial Manager
Position: Independent Contractor – Clinical Trial Manager
Term: 1 year
Reports to: Vice President, Clinical Operations
Travel: 30% or as needed to support role responsibilities
The independent contractor position of Clinical Trial Manager (“CTM”) is responsible for implementing the clinical trial strategy and management of Aurinia Pharmaceuticals clinical studies. The contracted CTM will be a team leader within Clinical Operations and manage operational and logistical tasks to ensure efficient execution of trials within established budgets and timelines, while ensuring all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP. This one year position will coordinate the efforts of internal and external resources to ensure efficient patient recruitment, trial site selection, trial plan optimization and execution of clinical trials with a focus on quality.
Responsibilities and Duties:
- Coordinate and oversee pre-approval and post marketing clinical trials;
- Support for clinical trial preparation activities including protocol design and development, Case Report Form design, site identification, third party partnership selection (CRO, Central Labs, etc.);
- Responsible for clinical trial activities including:
- primary point of contact for Investigators, Study Coordinators, and third party partners
- site qualification and monitoring
- data management including review of data clarification forms
- assistance with coding of adverse events and serious adverse events
- third party partnership management
- protocol compliance
- Review progress of projects and initiate appropriate actions to achieve target objectives; both budgetary and timeline;
- Provide updates and status reports on a regular basis; report on performance against plan;
- Assist with the development and implementation of SOPs for clinical trials and related activities;
- Interface with external vendors and internal departments of Aurinia Pharmaceuticals Inc. including Finance, Regulatory Affairs, Legal Affairs, New Drug Development, and Business Development;
- Provide training where necessary;
- Attend Investigator Meetings;
- Other such duties as may be determined;
- You will agree to comply with all signatory limits as communicated by the finance function on behalf of the company;
- You will comply with all Policies, rules, and regulations as set out and communicated by the company pursuant to good business practice.
- Bachelor of Science degree, Bachelor of Nursing degree, or equivalent. Advanced degree desirable.
- 5+ years of experience in the pharmaceutical or medical device industry as a clinical research professional, including successful project leadership role and hands-on managerial experience running clinical trials from inception to completion;
- Excellent knowledge of international regulatory and ICH GCP guidelines;
- Prior experience using computer applications including spreadsheets, email, word-processing software & web-based systems (EDC, IVR/IWRS, CTMS);
- Training and experience in monitoring of clinical trials and the related in-house and investigational site activities;
- Data management experience (preferred);
- Ability to work well as a member of multiple, integrated teams;
- Ability to contribute creative yet practical solutions to problems;
- Ability to multi-task and manage several projects in parallel while paying attention to detail. A wide degree of creativity and latitude is expected;
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion;
- Highly effective verbal and written communication skills with internal and external stakeholders;
- Ability to travel (including internationally) and work across cultures.
Please fill out the form below to submit your application.