2M Research Services is seeking a Senior Director of Clinical Operations to lead and support its Clinical Research Practice Group with commercial clients.
Support the development and implementation of 2M’s clinical research practice with an emphasis on clinical trial monitoring and regulatory affairs, including staff expansion
Support the development and management of 2M's clinical operations practice, and provide leadership to all commercial and government services employees within the clinical operations practice
Establish and approve clinical design and implementation of clinical protocols, data collection systems, and final reports
Support the negotiate clinical trial agreements, manage program budgets, and monitor adherence to protocols
Develop clinical system work plan schedules, milestones, cost estimates, and budgets for other systems within 2M’s clinical system solution suite
Maintain clinical research policies and procedures for 2M
Ensure compliance with all contractual obligations
Works to ensure that all project deliverables meet the customer's time/quality/cost expectations
Support business development and P&L of 2M’s Clinical Research Practice along with 2M's new Vice President of Clinical Research
MSN, MD, or PhD Degree in biomedical/life sciences with at least 10 years of relevant experience in clinical trial execution with a pharmaceutical company, medical device company, or CRO is required. Must have a technical understanding of key clinical systems, and the ability to translate that understanding into day-to-day operations, training presentations, and system/process documentation.
A solid understanding of FDA regulations on Good Clinical Practice, Declaration of Helsinki, and International Conference on Harmonization requirements
Ø Requires proficiency with clinical trial management systems and processes
Ø The ability to partner and influence people at all levels of the organization is required
Ø The individual must be self-motivated with a track record of demonstrated leadership abilities with both direct reports, peers, and the leadership of the organization
Ø Must have the ability to maintain and improve consistent and sound business processes in a dynamic, cross-cultural environment
Ø Must have problem-solving and decision-making skills along combined with strong planning, organizational, and project management skills
Must have key connections with commercial life science firms conducting clinical trial.
Must be a collaborative participant on 2M’s leadership team
Must be creative, flexible and have a great sense of humor
Must be a self-starter, organized, and an out of the box thinker
Must have strong writing and project management skills
Must have strong business development skills and a track record of success with commercial clients.
Telecommuting is allowed.
Internal Number: 1001
About 2M Research Services, LLC
2M Research Services, LLC is a fast growing contract research organization supporting federal and commercial clients in the areas of clinical research monitoring, epidemiology, Pharmacovigilance, pharmacoeconomics, and biostatistical support.