Senior Clinical Research Manager / Assoc. Director (ADX-319-20)

POSITION SUMMARY:

ArcherDX is hiring a Sr. Clinical Research Manager / AD to help lead clinical trials in the Clinical Development and Operations Department. In this role you will be responsible for the day-to-day management of clinical trials and will manage the study management team, vendors, clinical monitors and clinical trial sites. This position will also work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.

This position is a key member of the Clinical Development and Operations team and responsible for ensuring achievement of own or others’ project goals and objectives. This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates.

RESPONSIBILITIES:

• Manages the operational aspects of IVD clinical trials including turnaround time and reagent flow
• Participates in protocol, CRF development, Clinical Study Report preparation, PMA submission, as appropriate
• Prepares metrics and updates for management, as assigned
• Proactively identifies potential study issues/risks and recommends/implements solutions 
• Participates in and facilitates CRO/vendor selection process for outsourced activities
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
• May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
• Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Clinical Site Procedures Manual, and CRF Completion Guidelines)
• Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
• Participates in the development, review and implementation of departmental SOPs and processes
• Recommends and implements innovative process ideas to impact clinical trials management
• Organizes and manages internal meetings, investigator meetings and other trial-specific meetings
• Serves as a liaison and resource for investigational sites
• Responsible for gaining and maintaining ethics approvals during trials
• Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
• Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
• Safeguarding the privacy and security of protected health information and European Union personal data
• Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.

EDUCATION:

• BS/BA or higher in a science or health related field required
• Ph.D. or advanced scientific or medical degree is a plus

EXPERIENCE:

• Leveling commensurate with number of years of experience. 
• 5+ years of industry experience, with at least 3 years of direct clinical trial management experience at a sponsor or CRO
• Proven experience in managing CROs, specialty labs, outside vendors and international trials
• Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment 
• Demonstrated knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
• Ability to travel up to 30% of time
• Proven ability to provide clinical expertise in clinical development in a specified product area or project
• Next Generation Sequencing and/or other diagnostic laboratory experience is a plus
• Knowledge of clinical laboratory operations is a plus
• Ability to work in a fast paced and dynamic environment