Study Start Up Specialist/Lead
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.
The Study Start Up (SSU) Specialist/Lead will manage the start-up process including the critical path to site activation. The role will oversee start-up activities including preparation and submission of site regulatory documents to local or central ethics committees and negotiating site contract and budget. The SSU Specialist/Lead will coordinate with cross-functional teams to ensure site activation aligns with corporate timelines.
Essential Duties and Responsibilities:
- The Study Start-Up Specialist/Lead is accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to US regulations, Core/Site document collection/ approval, ICF customization/approval, SIV scheduling and activation requirements.
- Coordinate essential documents collection with study sites in accordance with local processes.
- Coordinate the Feasibility activities.
- Coordinate the identification and selection of research sites.
- Create, maintain/track, and obtain approval on essential study start up documents.
- Assist with activities relating to identification vendors as applicable.
- Work with the Study Manager on developing study specific strategic plans.
- Ensures compliance to established negotiation parameters, authority approval, contractual process and SystImmune expectations.
- Ensures compliance of budgetarty guidance, templates and process.
- Manage the study start up process, through development of a site activation strategy and to oversee start-up delivery.
- Coordinate, develop and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, ICF Customization, Start Up Risk Mitigations, Site Activation Requirements & Relevant Tools.
- Collaborate and communicate within the study team matrix to provide study start up strategy, input to milestone development, and alignment of operational targets to ensure timely delivery of study start up activities.
- Participate in study operational meetings with respect to study start up, including SSU Operational Targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics.
- Partner closely with both Functional Leaders and SystImunne Clinical Operations team to proactively identify study start up related issues.
- Develop and execute corrective actions to mitigate risks to activation timelines.
- Deliver and maintain corporate-focused reporting to measure performance and proactively identify issues for resolution.
- Ability to travel, as required.
Required Skills & Qualifications
- Bachelor’s Degree with 3+ years of clinical research experience at a pharmaceutical company, Biotech or CRO.
- Detailed understanding of clinical trial process across Phases I-II and ICH GCP.
- Extensive knowledge of the top US oncology site’s start up process.
- Ability to understand clinical protocols and associated study specifications.
- Detailed understanding of clinical trial start-up processes.
- Ability to manage external vendors to contract effectively.
- Strong organizational skills with ability to handle multiple tasks effectively.
- Strong written and verbal communication and interpersonal skills.
- Ability to manage multiple project budgets with increased complexity and value.
- Quality-driven in all managed activities.
- Good negotiating skills.
- Good problem-solving skills.
- Demonstrated ability to work independently as well as part of a team.
The hiring pay range for this position is $90,000 - $125,000 per year based on skills, education, and experience relevant to the role.
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]
Are you interested in this position?