Clinical Project Manager

The Clinical Project Manager will oversee the planning, implementation, and execution of clinical trials. They will also ensure that studies are conducted in accordance with regulatory requirements, study protocols, timelines, and budgets. The Clinical Project Manager will act as the primary liaison between cross-functional teams and suppliers.

RESPONSIBILITIES

• Manage all aspects of clinical trials from start-up to close-out, including planning, execution, monitoring, and reporting.
• Develop and maintain detailed study project plans, timelines, budgets, procedures, staffing requirements, allotment of available resources, and risk mitigation strategies.
• Coordinate clinical study timelines with applicable teams to meet critical milestones; escalate issues that may jeopardize timelines and deliverables.
• Oversee day-to-day clinical trial activities, including site management and enrollment tracking.
• Manage external suppliers.
• Participate in site visits, monitoring oversight, and resolution of site issues.
• Ensure that trials are conducted in compliance with applicable regulations, internal policies, and procedures.
• Implement appropriate systems, standards, and processes to ensure trials are conducted in compliance with applicable regulations and internal policies and procedures.
• Facilitate cross-functional team meetings, ensuring that team meetings have structure and clear purposes and goals; facilitate and drive meetings effectively, and clearly communicate decisions and action items to team members and relevant parties outside of the team.
• Provide regular updates on study progression to senior leadership and other stakeholders; proactively identify and resolve issues that arise during the study; manage the escalation of study-related issues.
• Coordinate with Quality Assurance to ensure internal and external study team members are trained on the appropriate policies and procedures.
• Guide teams through the effective development, management approval, and execution of strategic plans for assigned studies; this includes ensuring risk management plans are fully developed, contracts are agreed upon and adhered to, change control procedures are followed, communication within and external to the team are effective, duties, responsibilities, and scopes of authority are properly assigned, and approved team resources are appropriately planned and managed.
• Develop and manage clinical trial budgets and track against spending forecasts.
• Provide mentoring and technical oversight to team members.
• Ensure the efficient use of resources and escalate where adjustments are needed.
• Participate in audits and inspections as needed.
• Other duties as assigned.

EDUCATION REQUIREMENTS

• Bachelor's degree in Life Sciences, or related field.

QUALIFICATIONS

• Possess 5+ years of clinical research experience, including 2+ years in a project management role.
• Exemplify thorough knowledge of applicable regulations.
• Possess strong experience with the management of CROs and other vendors.
• Demonstrate strong knowledge of protocol, processes, clinical trial study design, study planning and management, and monitoring.
• Possess the ability to solve complex problems, apply judgment, and make clear recommendations.
• Exemplify the ability to multitask and thrive in an agile, fast-paced, deadline-driven environment while remaining flexible, proactive, resourceful, and efficient.
• Possess proficient verbal and written communication skills, while willing to share and receive information and ideas from all levels of the organization to achieve the desired results.
• Possess high ethics and conduct business in the most professional manner.
• Seek inclusiveness and collaboration but step up to responsibility, make tough decisions, and be accountable for those decisions.
• Act as a results-oriented team player with strong interpersonal and communication skills, capable of working collaboratively with colleagues.

SCHEDULE
This is a salaried position, requiring at least 40 hours per week. There may be projects that require activities beyond the standard hours.

This role will require travel up to 25%.

COMPENSATION & BENEFITS

• Base salary range: $130,000 - 150,000/annually determined based on the candidate's experience, knowledge, and abilities.
• Bonus: discretionary annual bonus based on a percentage of the employee's base salary.
• Benefits: health, vision, dental, life insurance, 401k (with employer match), and paid time off.
• Company Stock Options

ADDITIONAL INFORMATION

Geneoscopy's Core Values
Ability to embody Geneoscopy's beliefs, philosophies, and principles:

• Integrity - we do the right thing through our words, actions, and behaviors
• Courage - step up, speak up, stand out
• Agility - think and act fast, embracing change
• Passion - for our customers, our people, our work, and for excellence
• Collaboration - our differences are assets

Physical Demands

• Employees may be required to lift routine office supplies and use standard office equipment.
• Must possess the ability to sit and/or stand for long periods.
• Must possess the ability to perform repetitive motion.

Work Environment

• May have exposure to fumes and bio-hazardous material in the laboratory environment.
• May be required to handle blood-borne pathogens and general laboratory reagents.

By completing this online employment application, you certify that the information on this application is true and complete to the best of your knowledge. You understand that any misrepresentation or omission of fact in response to any inquiry made in this application may result in the rejection of the application or if hired, dismissal whenever it is discovered. You authorize and release all parties from any liability or damage that may result from seeking, furnishing, or using such information. You understand and agree that, if hired, your employment is for no definite period and may, regardless of the date of payment of compensation, be terminated by Geneoscopy at any time, for any or no reason, with or without notice. You understand that no representation to the contrary is valid unless in writing, setting a definite term of employment, and signed by the company's CEO. You further understand and agree that any job offer is contingent upon your passing, to the company's satisfaction, a criminal background check, reference checks, and other possible screenings. You understand that this application is active for 90 days only, and if you do not hear from the company but still wish to be considered for employment after 90 days, you will need to fill out a new application.