CLINICAL TRIAL SPECIALIST – #1469
Our client company is a well-established clinical-stage T-cell focused biopharmaceutical company. Their leading drug candidate is uniquely positioned to address key unmet medical needs in immune-oncology and other diseases. They are partnered with industry and academic leaders to investigate combinations with leading immunotherapeutics and to rapidly expand into additional combinations such as CAR-T. They are well-funded and rapidly expanding. We are assisting them in identifying qualified candidates for this position on an exclusive search basis.
This position is fully remote although our client is located in Maryland
Responsibilities of the Clinical Trial Specialist
- Provide support for the day-to-day execution of clinical trials following GCP and company’s SOPs. Maintain all trial data logs and ensure accuracy of all study materials and partner with Clinical Project Managers to oversee study conduct.
- Plan and track all clinical activity and monitor all trials. Oversee and manage vendors, review contracts/budgets, performance accountability, train vendors on protocol specification and assess and approve invoices. Be accountable for trial documentation and ensure inspection readiness of respective clinical trial(s) at all times. This includes timely documentation of deviations, creation of story boards or issue summary documents (e.g. for high risk areas/hot topics.
- Work closely with Clinical Scientist/Clinical Lead and other cross-functional team members to develop study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference Binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR), etc.
- Ensure an update on pharmacy manual and manage clinical and drug supplies and provide an interface for drug supply forecasts.
- Work with clinical operations teams in the review of clinical data including providing guidance on issues/queries as needed and implementing risk management concepts as appropriate.
- Be responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory document/packages.
- Conduct sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs, and protocol as needed
- Collaborate with Clinical Project Managers to create, manage, and report timelines, risk registry, operational logistics and assess study process to ensure all stakeholders are informed and aligned on deliverables
- Write medical reports and supporting the publishing of documents
- Have a sense of urgency and support overall organizational objectives
- Other tasks assigned by the Chief Executive Officer (CEO) or Chief Medical Officer (CMO)
- Experience in management of Oncology trials or pediatric trials preferred
- Able to travel domestically (~ 5% or less, not applicable during COVID-19 pandemic)
- Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
- At least 1-2 years previous experience in study coordination (e.g., study site) or study management (e.g., CRO or sponsor)
- Fluency in study phases and demonstrable knowledge of how they apply to clinical development
- Strong working knowledge of ICH Good Clinical Practice guidelines
- Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management)
- Able to handle multiple tasks and deadlines
- Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
- Initiative, Excellent attention to detail, able to identify issues and take appropriate actions
- Highly effective verbal and written communication skills
- Experience using computer applications including spreadsheets, email, word-processing software, and web-based systems
- Prior experience with eTMF, CTMS, and EDC systems preferred