Clinical Project Manager
Redmond, Washington
SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.
Summary:
SystImmune is seeking a high quality, ambitious and experienced Clinical Project Manager to implement and oversee projects, and to ensure the quality of trials. As a Clinical Project Manager, you will be responsible for the day-to-day operations of one or more clinical studies including, financial planning, budget management, study timelines and CRO oversight.
The successful candidate will be working with a synergistic team, in a highly visible position where a flexible working approach is encouraged. This is an opportunity where you can make a significant impact in a progressive biopharmaceutical company, with a strong pipeline and exciting future in oncology research.
Essential Duties and Responsibilities:
- Proactively manage project level operational including management of trial timeline, budget, resources and vendors/CRO.
- Provide efficient updates on trial progress to the Sr. Director of Clinical Operations and Chief Medical Officer (CMO), with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
- Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
- Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
- Ensure potential study risks are escalated to the attention of the Sr. Director of Clinical Operations when appropriate.
- Chair Clinical Team working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
- Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
- Monitorthe quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.
- Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner.
- Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
- Ensureall project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.
- Effectively provide support to CROs in the conduct of the trials.
- Perform other duties as assigned.
Required Skills & Qualifications:
- Bachelor’s degree in health science or related field.
- Minimum of 5 years in clinical trial management.
- Therapeutic experience in oncology (preferred).
- CRO management experience.
- Ability to proactively handle and prioritize multiple tasks, manage a diverse range of functional activities, and solve problems simultaneously.
- Ability to work successfully in an entrepreneurial and fast-moving environment.
- Working knowledge of ICH guidelines, GCP, and current global regulatory requirements and guidelines for clinical trials.
- Highly responsive and proactive, a team player.
- Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) andother clinical trial systems (e.g., CTMS, EDC and eTMF)
- Ability to travel as required.
SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to [email protected]