Clinical Trial Manager / Sr. Clinical Trial Manager

Job Overview
Company Background:

GenVivo is a private clinical-stage company with breakthrough vector platforms for cancer treatment. Our Mission is to develop innovative off-the-shelf, targeted, and personalizing vector-based immunotherapies, that activate a patient’s own tumor-killing immune responses to fight cancer. Our Vision is to provide first- and best-in-class cancer therapies that are immediately and easily deployable, highly effective, and improve patient’s overall survival and quality of life beyond current therapies. We are an ambitious, growing company, whose employees are enthusiastic and passionate, respectful of each other, and highly committed to our mission, vision, and values. The company thrives on collaboration and is one where every individual and idea is important and counts.

General Job Description/Team Overview:

The Clinical Trial Manager (CTM) leads the study team responsible for the global execution of complex, early phase clinical trials from study design through study close out including oversight of all trial related activities. This individual is responsible for the quality of all work done on the trial and must ensure adherence to ICH GCP guidelines and all SOPs. The CTM leads and has expertise in implementing, applying, and integrating clinical project processes cross-functionally and promoting open and efficient communication among and between various team members and stakeholders. It is an excellent opportunity for a reliable, proactive individual who thrives in a dynamic biotech environment.

Primary Duties and Responsibilities (include but are not limited to):

• Serves as the leader for the execution, daily management, and oversight of assigned clinical trial(s).
• Leads the team’s identification and selection of CROs, vendors, KOLs, and investigational sites.
• Performs study-level sponsor oversight of outsourced clinical activities, including vendor management of CRO(s), labs, imaging, and other vendors
• Provides clinical input and manages the study team’s development of the key study documents, including protocols, ICFs, IBs, SRMs, study plans, and manuals.
• Leads the completion of clinical sections for the regulatory filings, including INDs, amendments, and annual reports. etc.
• Manages and communicates study costs, study status, and issues to ensure informed decision-making by senior management. Completes and maintains internal clinical trial metrics, dashboards, and other internal updates.
• Initiates and manages study timelines, including communication to internal and external team members on deliverables.
• Supports other cross-functional teams as a Clinical Operations representative.
• Manages the overall quality of the study data and reviews clinical data to ensure entry and readiness for data review meetings.
• Performs periodic reviews of quality metrics and study deviations.
• Leads problem-solving and resolution efforts to include management of risk, contingencies, and issues.
• Provides specific training and education for internal and external project team members as needed. Creates materials and presents at Investigator Meetings, SIVs, and vendor training.
• Drafts and oversees the drafting of site materials, including training, manuals, and support documentation, and is a liaison and resource for investigational sites.
• Manages trial feasibility process and oversees site feasibility/capability assessments.
• Reviews clinical monitoring reports to ensure identification of site issues.
• Reviews and provides clinical operations input into the development of vendor-related documents, such as central laboratory specifications and manuals, imaging charters, and other vendor documents.
• Participates in testing of clinical trial systems/databases (i.e. UAT).
• Manages invoice and budget tracking for individual studies and contributes to budget forecasting activities.
• Participates in QA and regulatory agency audits.
• Operates both independently and as a team member depending on current company priorities.
• Maintains professional relationships with internal and external study teams and stakeholders.
• Supports the mission and strategic plan of the Company.
• Occasional travel to site/vendor locations or for important meetings.
• Performs other duties as assigned.

Required Qualifications:

• Bachelor’s or Master’s degree preferably in health/medical related or life sciences area.
• At least 3 years of directly related experience in clinical trial management in a pharmaceutical, biotechnology, or academic environment with emphasis on early Phase clinical trials.
• Therapeutic experience in oncology.
• Global trial experience is desirable.
• Must possess a strong understanding of clinical drug development, ICH GCP guidelines, and the regulatory requirements for clinical trials.
• Must have a thorough understanding of clinical trial design, eCRF design, project management, and data handling.
• Must have experience in managing and working with CROs and other clinical vendors.
• Effective leadership skills, strong communication competency, and proven ability to foster team productivity and cohesiveness.
• Able to anticipate change and show flexibility.
• Proficient in computer skills, including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.
• Excellent organization skills with attention to detail and accurate record keeping.
• High degree of discretion dealing with confidential information.
• Ability and willingness to work flexible hours when needed.
• Demonstrated ability to work independently and in a team environment.
• Excellent written, verbal, and interpersonal communication skills.
• Eligible to work in the U.S.

Job Type: Full-time

Pay: $125,000.00 - $165,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Ability to Commute:

• San Marino, California 91108 (Required)

Ability to Relocate:

• San Marino, California 91108: Relocate before starting work (Required)

Work Location: Hybrid remote in San Marino, California 91108