Clinical Research Manager / Sr. CRM
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
ArcherDX is hiring a Clinical Research Manager / Sr. CRM to help lead clinical trials in the Companion Diagnostic Program. You will be responsible for the day-to-day management of clinical trials and may manage a study 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. Will be 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.
· 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 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.
- BA/BS or higher in a science or health-related field required
- Ph.D. or advanced scientific or medical degree is a plus
- 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
- GCP training and experience
- Experience with Medical Device and/or Oncology trials a plus
- Next-Generation Sequencing and/or other diagnostic laboratory experience is a plus
- Proven ability to provide clinical expertise in clinical development in a specified product area or project
- Knowledge of clinical laboratory operations is a plus
- Ability to travel up to 30% of time