Job Description

The Clinical Trial Manager will lead, manage, and coordinate the operational delivery, risk management, and overall execution of clinical trials from study start-up to close out at a regional or global level in accordance with ICH-GCP and applicable local regulations. This role will collaborate with cross-functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing. This role may work collaboratively on one trial or across several trials to support clinical operations activities. This role is based in our South San Francisco, CA office.

• Lead and coordinate a cross-functional study team (regional or global) to ensure the clinical trial progresses as planned.
• Accountable for the overall operational delivery (e.g., country and site selection/start-up, site contracts, patient recruitment and retention, etc.) of assigned clinical trials or regions; ensuring that study-level deliverables are met according to timeline, budget, and quality requirements.
• Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs.
• Drafts and implements study plans including vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF.
• Ensures TMF creation and QC completion.
• Supports EDC, IxRS, and CTMS systems and data maintenance.
• Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.
• Provides input to the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution.
• Participates in the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale.
• Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work.
• Leads the Investigator Meeting preparation and execution with the support from cross-functional team members
• Stays current on relevant therapeutic area knowledge and clinical research best practices.
• Ensures study adherence to ICH/GCP and company SOPs.

Qualifications

REQUIRED:

• Undergraduate degree in a scientific or health-related discipline with 5 years relevant experience of which 3 years are clinical experience in the pharmaceutical industry.

PREFERRED:

• One year of study management experience.
• Demonstrated ability in clinical study management processes and clinical/drug development.
• Highly effective verbal and written communication skills; effectively deliver key messages; aptitude to independently communicate with teams and stakeholders.
• Experience with effective vendor management.
• Strong customer focus with investigators, functional peers, vendors, etc.
• Excellent planning and organizational skills.
• Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.
• Ability to build trusting and collaborative relationships globally.
• Willingness to travel domestically and internationally and work across cultures.

Additional Information

The pay range for this position at commencement of employment is expected to be between $145K and $170K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.