Senior Director of Clinical Operations and Quality Management
Cohen Veterans Bioscience is seeking a Senior Director of Clinical Operations and Quality Management with substantial drug development and clinical trials experience, preferably in Central Nervous System conditions, to drive operational strategy and execution excellence for CVB’s clinical research program.
Reporting to the Executive Director, Clinical Programs the Senior Director of Clinical Operations and Quality Management will work from our NY City office (311 W 43rd St) to ensure consistency, quality and compliance with global clinical research standards, Good Clinical Practice (GCP), and company policies and procedures.
- Build and manage a Quality Management System
- Oversee the preparation and management of clinical trial and departmental budgets and timelines
- Track study progress, identify potential issues and proactively recommend mitigation plans
- Contribute to the development of clinical trial protocols
- Provide input into the content and execution of Investigator Meetings
- Participate in developing Clinical Sites training plans
- Contribute to and oversee the development of Study Manuals and other clinical trial documentation
- Participate in drafting informed consent templates and reviewing documents for IRB submissions
- Contribute to and oversee recruitment and retention strategies and execution; provide point of contact for escalated site questions relating to study conduct
- Drive and contribute to the evaluation, selection, and management of CROs and other clinical trial vendors
- Recommend and help establish clinical trial systems and processes, including documentation, QA, partnerships with CROs, investigator sites and physicians
- Participate in the development and implementation of other key organizational process improvement initiatives
- Participate in the recruitment and hiring, and direct management of CVB clinical operations staff
- Develop, implement and evaluate orientation and ongoing training for clinical operations staff
- Undergraduate degree required, advanced degree (e.g., PhD or PharmD) highly preferred
- 5 plus years in clinical trial conduct within the biopharmaceutical industry, preferably in Neurology and Psychiatry
- Must have a strong working knowledge of clinical study management, project and program budgets, and customer relations
- Must possess strong capabilities for both strategic thinking and attention to detail
- Must have strong decision-making skills and the determination to see projects through to the end.
- Must be comfortable with public speaking and communicating both verbally and in writing
- Demonstrated experience and leadership in the development and execution of clinical trials in the biopharmaceutical industry
- Willing to challenge the standard thinking with new ideas, new approaches, and new solutions.
- Demonstrated skills in leadership, management, and collaboration.
- Must be self-directed and able to work independently.
- Proven ability to quickly earn the trust of key stakeholders; mobilize and motivate teams.
- Must have proficiency with Microsoft Office PPT, Word, Excel and Project Management Tracking software.
- Excellent English communication, negotiation, and interpersonal skills.
- Familiarity with the Drug Development Process is required
- Must possess excellent team building, training and facilitation skills.
- Must have experience in contracting and negotiations with contracted research organizations and other vendors
- Ability to travel approximately 10% of the time
About Cohen Veterans Bioscience
Cohen Veterans Bioscience is a national, nonpartisan research 501(c)(3) organization dedicated to fast-tracking the development of diagnostic tests and personalized therapeutics for the millions of veterans and civilians who suffer the devastating effects of trauma-related and other brain disorders.
Please visit https://cohenveteransbioscience.applicantpro.com to apply. Please include resume, cover letter, and salary requirements. We offer a highly competitive salary commensurate with experience and a full benefit package. CVB is an Equal Opportunity Employer.
Publication Date: 3/12/19