Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA. Our mission is to bring innovation to clinical trial execution through passion, transparency, co-active communication, and integrity, to
facilitate the successful development of life-changing medicines and therapies. We are experts in clinical trial operations with a focus on Clinical Trial Management, CRO/Vendor Oversight, Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study Start-Up. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering integrity forms the foundation for our strong relationships both internally and as a partner to our Sponsor clients. Beginning with study development, we bring a “white glove service” approach to clinical trials.
Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients’ needs as they evolve.Our talented team is driven by passion and purpose, which has afforded us the opportunity to successfully lead clinical programs for pharmaceutical, medical device and biotechnology companies of all sizes in a variety of therapeutic areas. Our mission is to conduct clinical trials with outstanding quality on behalf of our clients to bring new drugs to market with the utmost integrity and confidence in the results.Position Overview:This is an exciting opportunity to join a young and lively company in a fast-paced and dynamic environment. The StudyStart-Up Manager (SSU)reports to theAssociateDirector, Study Start-Up.
This role will be responsible forthe execution and oversight of Study Start-Up activities, to include having ownership, oversight, and impact on regulatory and financial compliance (i.e., budgets and contracts). This role has broad responsibility for accelerating Study Start-Up activities, harmonizing processes, and providing Start-Up expertise to studies and programs to which they are assigned, to ensure study timelines and milestones are met.
Essential Duties & Responsibilities:
- Performs quality checks on country/site level regulatory submission documents and study level templateessential documents.
- Reviews the project SSU budget with the functional leads, Clinical Operations Manager, and the Associate Director, Study Start-Up against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations.
- Assumes accountability on Start-Up deliverables including, but not limited to: Site Identification and selection, Start-Up and life cycle maintenance regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses and extensions, study maintenance and amendment submissions).
- Oversees collation, quality review, and submission of country-specific applications.
- Utilizes tracking procedures for projects in accordance with executed contracts and sponsor expectations.
- Receives supervision and direction from Associate Director, Study Start Up and the Director of Clinical Operations on operational projects.
- Performs job-specific tasks in compliance with applicable Regulations, International Standards, and Vanguard Clinical Policies and Standard Operating Procedures.
- Serves as SME for budget and contract negotiations, local ethics boards, and regulatory environments, submission and approval processes, as well as other site-ready and ongoing project-level deliverables.
- Participates in the collection, preparation, review and tracking of documents for any or all of the following: Site Identification, Site Feasibility, Essential Documents, Regulatory Documents, IRB/IEC/REB, Site Contracts, and Site Budgets.
- Receives supervision and direction from Associate Director, Study Start-Up, Director of Clinical Operations, and works in collaboration with Project Directors and Clinical Trial Managers on operational projects.
- Leads or participates in site activation activities to help implement the Start-Up project plan as defined by Vanguard or the client’s SOPs.
Other Duties:
- Other work-related duties, special projects and/or other functions as required.
- Develops training materials, plans and/or templates for Vanguard Study Start-Up team
- Leads and develops junior staff
Experience & Skills:
- Minimum of 3-5 years of related experience at a biotechnology/ pharmaceutical company and/or CRO.
- Ability to interact with internal and external customers with a high degree of professionalism and discretion.
- Prior supervisory experience is preferred.
- Experience with all aspects of conducting clinical trials, from initiation through site close-out, prior clinical monitoring experience preferred.
- Prior experience reviewing protocols, amendments, and other study-related and/or regulatory documents.
- Thorough understanding of the drug development process.
- The position requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site-ready and ongoing projectdeliverables.
- Multi-phase study experience strongly preferred but not required.
- Strong operational and management skills
- Good organizational and time management skills
- Self-motivation, flexibility, ability to establish and manage multiple priorities, and multi-task effectively to meet stated internal and external commitments.
- Must exercise sound judgment and take initiative, be able to work independently with minimal supervision while producing accurate high quality and timely work.
- Must be able to work effectively within a team environment (independently and collaboratively).
- Excellent written and verbal communication skills including strong professional presentation skills (internal and external audiences)
- Thorough knowledge and understanding of ICH/GCP and applicable regulatory requirements.
Education:Bachelor’s degree in a scientific discipline from an accredited college or university is strongly preferred. Other bachelor's degrees with relevant industry experience will be considered.Travel Requirements:Travel to San Diego headquarters as needed, if not residing locally. Applicants with foreign transcripts/degrees must provide a U.S. equivalency report evaluation that indicates the degree to which the foreign coursework is equivalent from one of these evaluation agencies: https://www.naces.org/members.
Compensation Range:$80,000 - 130,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)COVID-19 Vaccination: To protect the health and safety of our employees and to comply with client requirements, Vanguard Clinical may require employees in certain positions to be fully vaccinated against COVID-19, subject to reasonable accommodations or exemptions for religious, medical, or other legally protected reasons. Vaccination requirements will depend on the client site requirements.
Proof of vaccination may be required, in accordance with applicable laws.Vanguard Clinical is an equal opportunity employer for all applicants and employees. Vanguard Clinical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
