Overview

Purpose

The Clinical Trial Manager is responsible for the ongoing execution of our Phase II study and will participate in future global Phase III programs. All activities are conducted in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, applicable regulations, rules, and guidance.

Curevo offers its employees a generous range of compensation and benefits.

The salary range for this position is $115,575 to $145,000 annually. The salary range may vary based on Curevo's compensation practices and an applicant's qualifications and experience.

Employees have the opportunity to earn an Annual Discretionary Bonus as well as being eligible to participate in Curevo's Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect. We have a Flexible Vacation Plan, Paid Sick Leave Plan earning 1 hour of sick time for 30 hours worked, and 10 paid holidays per year.

At Curevo, we believe the highest-performing teams include people from a variety of backgrounds and experiences who respectfully challenge each other and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.

About Curevo Vaccine

Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.

Attention: Search Firms / 3rd Party Recruitment Agencies

The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated should we hire from unsolicited resumes.

Recruiters are requested not to contact or present candidates directly to our hiring managers or employees and doing so may jeopardize eligibility to work on future positions.

Responsibilities

Key Role and Responsibilities

• Oversee set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and source documentation for Sponsor oversight of CRO and site activities.
• Ensure study regulatory files are collected, inventoried, and filed as per sponsor requirements. Oversight of CTA's for maintaining and auditing the Trial Master File.
• Assist in the preparation and follow-up of in-house and on-site quality audits, as well as regulatory authority inspections.
• Develop requirements/specifications for outsourcing to vendors. Works with Program Management team for review of vendor proposals, contracts, and budgets for accuracy with respect to the clinical trial protocol and trial activities. Review vendor invoices for accuracy as needed.
• Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) and other vendor activities to confirm integrity, accuracy and accountability of trial activities, clinical and research lab data ensuring compliance with the protocol, study manuals, IRB, ICH Good Clinical Practices (GCP), CFR, FDA, and applicable regulations. Perform sponsor audits of investigative sites and vendors.
• Coordinate with CRO and data management for data base cleaning, soft lock and final database lock and ensuring data timelines are met. Assist with guidance and review of tables, listings, and figures for interim analysis or final data output. Coordinate with biostatistics in the transfer of final data for statistical analysis and coordinate the review of statistical analysis plans by subject matter experts as assigned.
• Coordinate with CMC team for investigational product (IP) supply and any IP issues identified on site during clinical trial.
• Partner with consultants as assigned for review and obtain advice on clinical, and laboratory questions. Compile clinical trial operations materials and updates for consultants, Scientific Advisory Board, and Curevo Board of Directors.
• Contributes to the development of abstracts, presentations, manuscripts, and other external forms of communication.

Job Requirements

Qualifications

Preferred Education

• BS Degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).

Preferred Experience

• Minimum of 4 years clinical trial experience in the pharmaceutical, biotech industry, clinical trial site, or CRO, with at least 1-2 of those years managing clinical trial activities.
• Experience managing a CRO, as well as a complex study in a previous Clinical Trial Manager, or Clinical Project/Program Manager position.
• Ability to build strong relationship with the sites, vendors, consultants, and CROs.
• Experience in the set-up and management of third-party vendors, as well as study start up.
• Experience with Phases I & II clinical trials. Phase III & global trial experience a plus.
• Thorough knowledge of FDA, CFR, and ICH GCP requirements and other regulatory requirements.
• Up to 25% travel may be required.

Knowledge, Skills, and Abilities

• Strong leadership and management skills to provide planning, coordination and direction to staff and ability to propose innovative solutions to challenges.
• Outcome driven; can thrive in a fast-paced environment with rapid change while effectively managing pressure in a professional manner.
• Able to set up and track key metrics and motivate a study team throughout the project life cycle.
• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
• Proficiency with MS Office products (Word, Excel, PowerPoint, Outlook) and other electronic systems (CTMS, EDC, and eTMF). Experience with Smartsheet is desirable.
• Flexibility in work hours as needed to accommodate international collaborators o significant meetings/events. Flexibility for some remote and in-person combination on a weekly basis.