POSITION SUMMARY:

ArcherDX is hiring a Clinical Research Manager to help lead clinical trials in the Companion Diagnostic Program. 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 team and responsible for ensuring the 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 the duties or functions of subordinates.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

• 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 the 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, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy 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
• Set up and maintain internal clinical sample bank 
• Responsible for gaining 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:

• Bachelor degree 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 a number of years of experience. 
• 5 to 6+ 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

KEY ATTRIBUTES

• Drive and determination
• Ability to work in a fast-paced and dynamic environment
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
• Strong communication and presentation skills
• Self-starter
  
  15. Driven to perform
  15. Self-directed: needs little explicit direction 
  15. Able to organize, prioritize, and delegate tasks to efficiently move projects forward.