Position Overview

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.
    1. Bachelor’s Degree in related field or equivalent experience.
    2. Six plus years of clinical research experience in the medical device industry.
    3. One plus year of management or project management experience.
    4. Knowledge of clinical trial design, management, terminology, and related GCP and regulatory requirements.
    5. 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.
    6. Familiarity with basic study design and logistical elements such as protocol construction, database/CRF development, contracts, informed consent, randomization, monitoring, and statistical plans.
    7. Ability to self-start and work independently to actively drive studies to completion.
    8. Strong interpersonal skills to build effective relationships with physicians, research personnel, and internal business partners.
    9. Ability to work well in a team environment.
    10. Managerial skills with the ability to assign and monitor work.
    11. Strong detail-orientation and organizational/time management skills.
    12. Strong written and verbal communication skills with the ability to present to a small to midsized group.
    13. Proficiency in standard computer programs including MS Office.
    Desired Qualifications
    1. IDE and/or global clinical research experience.