Clinical Trial Manager, Clinical Operations
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Job Description
Clinical Trial Manager overseeing clinical trials from vendor selection to CSR completion at Spyre Therapeutics. Collaborating with internal teams and CRO partners in a fast-paced biotechnology environment.
Responsibilities:
- Responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion.
- Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements.
- Create and implement study-specific clinical monitoring tools and documents, including informed consent development and EU CTR.
- Lead the identification, evaluation, selection, and oversight of clinical trial sites.
- Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites.
- Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations.
- Responsible for implementation and oversight of Trial Master File for inspection readiness.
- Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates.
- Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents.
- Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports) along with other relevant project team members.
- Provide study updates and reports, inclusive of study risks and issues.
- Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, events and study management meetings.
- Responsible for ongoing study data reviews and data cleaning activities.
- Provide oversight of CTA and CRA activities such as site identification, qualification, selection, initiation, data quality, sample tracking, interim monitoring and close out activities.
- Manage trial-level quality risk management.
- Oversee study supplies management.
- Support the development and complete the delivery of study training to investigators, site staff and internal staff on study processes.
- Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections.
- Other duties as assigned.
Requirements:
- B.A./B.S. in life sciences or equivalent
- A minimum of 5 years of clinical research experience within the pharmaceutical or biotechnology industry, with at least 2+ years managing early phase clinical trials; managing global clinical trials a plus
- Inflammation and/or Immunology experience is strongly preferred
- Strong working knowledge of clinical operations and experience with clinical study conduct from start-up through close-out
- Informed consent development and EU CTR experience
- Ability to lead cross functional study teams in a matrix organization
- Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices; trial initiation and management practices and procedures
- Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions.
Benefits:
- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
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