Manages post-market clinical studies and other post-market clinical research activities. Job duties:
- Manages company-sponsored and investigator-sponsored clinical studies in line with institutional, GCP, regulatory, and compliance requirements.
- Collaborates with Clinical Research management, cross functional partners, study PIs, coordinating centers, CROs, and/or sponsoring institutions to develop protocols, establish budgets, construct databases, select sites, set enrollment targets, and implement enrollment and mitigation plans.
- Works with legal team to facilitate preparation of clinical trial agreements, vendor agreements, physician consulting agreements, and other related contracts.
- Partners with study site coordinators to prepare IRB submissions, address IRB questions, and achieve site activation.
- Prepares/supports the preparation of study documentation including protocol amendments, Case Report Forms, Informed Consent Forms, monitoring plans, study manuals, and other study tools.
- Interfaces with study site personnel, investigators, and vendors via regular email/phone contact, study newsletters, and in-person meetings.
- Reports and tracks study data, enrollment trends, and other metrics.
- Ensures appropriate safety/adverse events reporting.
- Tracks and manages study budgets and expenditures.
- Provides regular study status reports to management and internal business partners.
- Leads investigator/coordinator meetings and site trainings.
- Reviews publication drafts and fields physician requests for publication support as needed.
- Leads pilot data collection efforts as needed.
- Attends offsite study meetings and professional conferences as needed to support study startup and enrollment.
- Directs Clinical Research Associates, Clinical Research Coordinators, and administrative personnel as needed to support the above activities.
- Performs other clinical research-related duties as assigned.
- JOB ID 10298BR
- ALISO VIEJO, CALIFORNIA, USA
- Apply for this job
- Bachelor’s Degree in related field or equivalent experience.
- Six plus years of clinical research experience in the medical device industry.
- One plus year of management or project management experience.
- Knowledge of clinical trial design, management, terminology, and related GCP and regulatory requirements.
- Proficiency in the logistics of clinical study setup and management including study documentation development, site selection, budget development, IRB submission preparation, training, database oversight, and the tracking of study metrics.
- Familiarity with basic study design and logistical elements such as protocol construction, database/CRF development, contracts, informed consent, randomization, monitoring, and statistical plans.
- Ability to self-start and work independently to actively drive studies to completion.
- Strong interpersonal skills to build effective relationships with physicians, research personnel, and internal business partners.
- Ability to work well in a team environment.
- Managerial skills with the ability to assign and monitor work.
- Strong detail-orientation and organizational/time management skills.
- Strong written and verbal communication skills with the ability to present to a small to midsized group.
- Proficiency in standard computer programs including MS Office.
- IDE and/or global clinical research experience.