Clinical Trial Manager/Senior Clinical Trial Manager

Clinical Trial Manager /Sr. Clinical Trial ManagerCrystalys Therapeutics is a clinical-stage biopharmaceutical company focused on advancing innovative therapies to address the significant unmet medical needs of patients living with gout. Crystalys Therapeutics seeks a Clinical Trial Manager/Sr. Clinical Trial Manager who is an enthusiastic, motivated, results-oriented individual for our Clinical Operations organization.The Role:The selected candidate will be joining a growing team with ownership over ensuring Crystalys has world class clinical trial planning and execution in accordance with regulatory guidelines. Under the guidance of the Clinical Operations senior management team, the individual will support clinical operations and cross functional activities, providing leadership and management of operational and administrative activities.Responsibilities:• Support a patient-centered focus on clinical trial development and execution.• Demonstrate knowledge of clinical operations methodologies, organizational, project management, and leadership capabilities as well as strategic insight, decisiveness, and strong judgment.• Participate in development and review of key documents for the support of clinical trial execution including protocols, oversight plans, case report forms, and other study management plans as well as regular review of clinical site visit reports.• Encourage continuous quality improvement by evaluating methods and approaches and recommending efficient and/or novel approaches.• Support Clinical Operations leads in coordinating project meetings with third-party vendors, sub teams, and ad hoc working groups, including scheduling and drafting, distribution, and filing of meeting agendas and minutes.• Maintain study status tracking tools and reports to communicate project status updates and oversight of all study activities (e.g., site and country submissions, clinical trackers, plans development, and essential documents status).• Provide Sponsor oversight of study eTMFs, conducting periodic reviews to assure accuracy and completeness.• Assist in data listing review and clinical study listing reviews and coordination of team reviews of study-specific plans and documentation.• Support proactive identification, assessment, and effective management of clinical study challenges and risks.• Support resolution of study issues by identifying root causes as opportunities to improve project effectiveness.• Support establishment and maintenance of relationships with site investigators and personnel to ensure Crystalys is the partner of choice for clinical trials.• May perform periodic site/vendor visits to ensure compliance and maintenance of quality standards.• Ensure compliance with all SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards in the conduct of clinical trial execution.• Contribute to process improvement development and work collaboratively with internal and external stakeholders.• Crystalys’s hybrid model requires this role to work in our office two days per week on average.Qualifications:• BA/BS degree in life sciences or healthcare.• 7+ years of relevant experience in a clinical operations function, including Clinical Research Associate/site monitoring experience.• Clinical Operations experience with multi-center clinical trials from initiation through close-out.• Working knowledge of GCP, clinical trial design, regulatory processes, and global clinical development process.• Strong understanding of clinical compliance and inspection readiness, including essential documentation and eTMF management.• Understanding of cross-functional clinical trials processes (e.g., data management, safety, biostatistics, medical writing).• Ability to develop effective relationships with all relevant stakeholders.• Basic understanding of financial planning and managing clinical program budgets.• Strong verbal and written communication skills, able to prepare concise written documents and data presentations.• Strong attention to detail, accuracy in work, proven ability to work independently with a high level of integrity and creative problem-solving skills are essential.• Competent with MS platforms, including Word, Excel, PowerPoint and tracking tools.• Able to prioritize multiple competing demands.• Support a culture of continual improvement and innovation; promote knowledge sharing.• Willingness and enthusiasm to “wear multiple hats.”Location:Hybrid preferred, in San Diego office (Del Mar area) Tuesday & Wednesday.Base salary:(Exact compensation may vary depending on level, skills and experience.)Clinical Trial Manager: $120,000 - $158,000Sr. Clinical Trial Manager: $145,000 - $185,000Candidates apply directly to this posting for immediate consideration.Unsolicited resumes sent to Crystalys Therapeutics from recruiters do not constitute any type of relationship between the recruiter and Crystalys Therapeutics and do not obligate Crystalys Therapeutics to pay fees should we hire from those selected resumes.Crystalys Therapeutics is committed to diversity, and proud to be an equal opportunity employer. All qualified candidates will be considered for employment, regardless of race, color, age, ancestry, religion, national origin, gender, gender expression, gender identity, genetic information, parental or pregnancy status, sexual orientation, citizenship, marital status, disability, protected Veteran status, or any other characteristic protected by law.