Senior Clinical Operations Manager

Job Description

Job Description

Salary : $140,000-180,000 annually

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 Startup.

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 Senior (Sr.

Clinical Operations Manager (COM) is responsible for the oversight, implementation, execution and communication of clinical research studies and operations, including the management of clinical projects.

Responsibilities also include ensuring the successful conduct of one or more clinical trials. Providing oversight and operational planning to ensure all trial objectives and milestones are completed on time, within program budget and to quality standards.

The Sr. Clinical Operations Manager directly manages US and / or global operations of the trial with internal and / or external cross functional team members, including CRO(s) and study vendors.

Essential Duties & Responsibilities :

Study Management Responsibilities :

• Monitors all aspects of trial conduct and communicates overall study status, inform project planning or senior management of issues that may impact timelines, personnel or budget needs, patient safety, and quality of subsequent data.
• Leads cross-functional teams and facilitates communication and interaction amongst internal and external team members to ensure current communication on current program status and priorities and ensuring the goals / objectives are aligned with corporate expectations.
• Oversees the selection activities of vendors (e.g., CROs, central labs, IRT, etc.) who may support client programs. This includes identification of vendors, assessing capabilities, and evaluating requests for proposals (RFPs).
• Participates in the regular reconciliation of clinical study budgets.
• Manages external vendors and CROs, including establishing expectations and timelines and clear and ongoing communication.
• Identifies and manages clinical task milestones, establishes performance timeline for individuals and projects.
• Identifies and documents risks to clinical trial execution and develop risk mitigation strategies.
• In collaboration with the Clinical Development staff, initiates and manages all aspects of the conduct of clinical studies (Phases I-IV).
• Assist COMs with escalation issues for study management concerns.
• Authors study-related documents and plans (e.g., project management plan, monitoring plan, informed consent form, vendor oversight plan, newsletters to sites), in accordance with Vanguard Clinical and / or client SOPs.
• Maintains a productive work environment by establishing, maintaining, and enforcing standards and procedures, complying with all applicable regulations.
• Works closely with clinical supply personnel to ensure timely availability of supplies for the conduct of clinical trials.
• Serves as the primary in-house resource for responding to Investigator and site staff questions regarding eligibility, enrollment, safety concerns, or data quality;

triage to Sponsor for input as needed. Resolves logistical sites issues independently.

• May contribute to the writing and / or review of clinical study documents (e.g. Protocol, Pharmacy Manual, Investigator’s Brochure).
• Participates in BLA / NDA / IND planning and submission activities.
• Manages recruitment, enrollment, and trial marketing initiatives.
• Plans, prepares, organizes and presents study content or other topics at study meetings (e.g. Kickoff Meeting, Investigator Meeting, Site Initiation Visit, etc.).
• Provides oversight for the execution and development of staff training plans, SOP review, and training experiences as applicable.

Other Duties :

• Mentors junior COMs through practical expertise and formalized training, as needed.
• May assist in the hiring process for various clinical operations roles, as requested.
• May support the onboarding process for new hires.
• Assists in preparation of and revision of Vanguard Clinical SOPs.
• Identifies system enhancements necessary for improved tracking, education and follow-up activities and coordinates the development with the company’s clinical operations staff.
• Other work-related duties, special projects and / or other functions as required.

Experience & Skills :

• Minimum of 3-5 years of related experience at a biotechnology / pharmaceutical company and / or CRO.
• Experience either working at a CRO or overseeing CROs is preferred.
• Experience with all aspects of conducting clinical trials, from initiation through site close-out, prior clinical monitoring experience a plus.
• Prior experience reviewing protocols, amendments, and other study-related and / or regulatory documents.
• Multi-phase experience strongly preferred but not required.
• Strong operational and 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).
• Strong knowledge of drug / device development processes (domestic and international) is required.
• Knowledge in oncology or rare disease trial execution is a plus.
• Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.).
• Understanding of current GCPs / ICH / FDA regulations and guidelines to assess compliance with applicable regulations and guidelines.

Education : Bachelor of Science 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 :

$140,000 - 180,000 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.

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