Clinical Trials Manager
Employment Type: Full-Time
Provides leadership and manages clinical trial activities. This position coordinates and collaborates with others in cross-functional teams; and oversees the deliverables and accountability of consultants, temporary staff, and contract research organizations (if applicable). This position is accountable for successful planning, implementation, monitoring and closure of clinical studies in accordance with Good Clinical Practices, other relevant regulations, and Spectrum SOPs.
* Manage Study Team to achieve corporate and Project Team milestones on time and on budget.
* Provide oversight of study team conducts to ensure overall study monitoring compliance.
* Develops full suite of planning tools for each clinical trial, including Study Oversight Plan, Clinical Monitoring Plan, enrollment plan, communication plan, contingency plan, start up and closure plan.
* Updates study plans with forecasts, including but not limited to site start up, enrollment, and closure.
* Tracks and reports study metrics (site and patient status, CRF completion, query status) against plan.
* Develops site budget in collaboration with Clinical Business Operation Manager.
* Develops and implements study-specific monitoring and site training tools, and oversees training.
* Reviews and approves site visit reports.
* Provides oversight of TMF submission and maintenance.
* Reviews and approves invoices from investigators and service providers.
* Provides Finance with activity forecasts to allow for appropriate accrual.
* Develops and fosters positive working relationships with colleagues, development and service partners.
* Acts as primary contact for all study activities.
Required Skills, Education and Experience:
* Five-year of experience with clinical trials as a CRA or related discipline.
* Five-years of experience leading teams.
* Strong working knowledge of GCP/ICH regulations.
* Demonstrated superior communication and collaboration skills.
* Strong organizational, planning and follow-through skills.
* Demonstrated leadership skills in multi-disciplinary situations.
* Ability to effectively interact with all levels of management.
* Ability to work well under pressure and with tight schedules.
* Ability to resolve problems positively and professionally.
* Have an in-depth understanding of clinical research. Have a working knowledge of the relevant SOPs.
* MS Word, Excel, in-depth knowledge of other presentation programs a plus.
* Excellent language and grammar skills, ability to write clearly and concisely.
* Attention to detail and the ability to prioritize.
* Ability to exercise judgment within generally defined practices and policies for obtaining data.
* Self-direction and motivation.
* Oncology experience preferred.
Position Location and/or Territory and Travel:
* Position is located in Irvine, California.
* Position may require approximately 25% domestic and international travel.
Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.