Clinical Research Manager (ADX-239-19)

| Greater Boulder Area
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Clinical Research Manager (ADX-239-19)

 
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
 
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 
 
POSITION SUMMARY:
 
Residing in our Boulder, CO office, the 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:
  • 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
    1. Driven to perform
    2. Self-directed: needs little explicit direction 
    3. Able to organize, prioritize, and delegate tasks to efficiently move projects forward. 
 
 
 
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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

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

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

How do your team's ideas influence the company's direction?

The marketing team brings in and drives the voice of our customers across the organization. Each strategic decision we make at ArcherDX is informed by a deep, customer-centric approach, where we use our insights to better understand how we can deliver an exceptional experience and aim to positively impact the lives of the patients we serve!

Ali

Director, Global Marketing

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Employees who have been with the company for 12 months are eligible for 12 weeks of family medical leave.
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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