Senior Manager, Clinical Operations

Title: Senior Manager, Clinical Operations

Overtime Status: Exempt

Employment Status: Full-Time

Pay Range: $140,000 - $150,000 /hourly DOE

The hiring pay range for this position is $140,000 - $150,000 per hour based on skills, education, and experience relevant to this role.

Inventprise is a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. Inventprise is led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.

At Inventprise, we believe our people are our most valuable asset. We are strongly committed to a range of workplace programs that support the well-being, growth, and engagement of our employees and our business. What we offer:

Benefits:

Effective the first of the month following the date of hire, employees are eligible to participate in the following Inventprise employee benefit programs:

• Medical, Dental, Vision, FSA, or HSA: Currently Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and enrolled spouse and dependents. Medical plans are currently provided through Premera Blue Cross.
• 401(k) program: Inventprise contributes 3% of employee base pay each pay period to their 401(k) account. Employee contributions are at the discretion of the employee.
• Paid Time Off: Employees start PTO accruals at the rate of 5.83 hours each pay period - annualized equivalent of 140 hours/year.
• Paid Holidays: Inventprise offers 9 paid holidays each year: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Day after Thanksgiving Day, Christmas Day, and two floating holidays.
  
• Stock & Bonus Plans: Employees are eligible to participate in the Company’s Bonus and Stock Award Plans.

Summary:

This role will be responsible for independently providing operational oversight of the planning, implementation, and close-out of vaccine clinical trials sponsored by Inventprise Inc. In collaboration with Portfolio Management, the role will also interface with the various internal and external stakeholders in the area of clinical supplies, clinical testing management, vendor management and other cross-functional teams.

Duties And Responsibilities:

• Develop, maintain, and manage high-quality detailed study timelines; interface regularly with study team and internal cross-functional stakeholders to ensure key activities are well-coordinated, are accurately reflected on the study- and program timelines and align with corporate and program goals.
• Prospectively identify timeline risks, proactively communicate risks to management, internal stakeholders, and CRO teams, and coordinate development and implementation of risk mitigation strategies to facilitate efficient, on-time execution of studies.
• Collaborate with other functional groups within the company where necessary to support milestone achievement.
• Manage routine status reporting including study timeline and budget dashboards and management updates.
• Provide monthly milestone and timeline updates to Portfolio Management for entry into corporate project management system.
• Develop, maintain, and manage high-quality detailed study timelines; interface regularly with study team and internal cross-functional stakeholders to ensure key activities are well-coordinated, are accurately reflected on the study- and program timelines and align with corporate and program goals.
• Prospectively identify timeline risks, proactively communicate risks to management, internal stakeholders, and CRO teams, and coordinate development and implementation of risk mitigation strategies to facilitate efficient, on-time execution of studies.
• Coordinate development and review of IP labels, working closely with relevant functional areas to produce a final mockup label meeting clinical and regulatory requirement.
• Develop and contribute to appropriate study plans (e.g., monitoring, pharmacy, data management, laboratory, manual of procedures, communication, etc.).
• Oversee protocol implementation by reviewing progress reports from CROs, monitoring, and data quality reports, and audit reports as needed.
• Support procurement, import, and delivery of clinical trial supplies (including Investigational Product) according to trial protocol specifications.
• Oversee clinical trial registry postings.
• Provide input into the selection and qualification of clinical trial sites and CROs
• Provide input into the contractual activities of clinical sites and CROs, including outlining partner roles and responsibilities and technical milestones triggering payments.
• May work on 1-3 clinical studies depending on complexity and design

Education and Experience:

• Bachelor’s in related discipline required; a combination of relevant education and applicable job experience may be considered.
• 7 years of related experience in a CRO, Biotech or Pharmaceutical organization
• Solid understanding of drug development and Clinical Operations.
• Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint and Outlook.
• Must be a self-starter who works with minimal supervision.
• Works effectively in a matrix cross-functional environment.
• Good business judgment and a strong understanding of the unique aspects of clinical financials.
• Excellent communication skills, (verbal and written) including the ability to understand and present budget information effectively.
• Works with high sense of accountability/urgency
• Expertise in GCP, ICH, and other Guidance documents and policies related to clinical trial operations.

Physical Demands:

• Adequate visual and mental acuity to maintain prolonged use of computer work.
• Multiple hours of standing, sitting, or walking when performing computer work.

Mental Demands:

• Requires operational discipline to consistently focus and execute work-related tasks, with a minimum of human error. This involves self-checking of work immediately upon completion, the ability to find / correct errors (with oversight by the Supervisor).
• Self-directing, once training is successfully completed, but with need to immediately elevate potential concerns/discrepancies to management in a timely fashion.
• Must maintain a professional demeanor in communicating with all Inventprise personnel.

Working Conditions:

• Remote, with on-site presence based on business needs. ,
  
• International and domestic travel 15-20%.
  
Must have expertise in MS Project/Smartsheet.

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Inventprise is an equal-opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.