Clinical Research Manager / Sr. CRM (ADX-286-20)

| Greater Denver Area | Hybrid
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Clinical Research Manager / Sr. CRM

 

COMPANY SUMMARY:

 

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.

 

POSITION SUMMARY:

 

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.

 

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.

 

REQUIREMENTS:

  • 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

 

 

 

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Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

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