Senior Clinical Trials Specialist - United Kingdom
Want to know company name or location? Company managed [?]
- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- Our company is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs.
- The Senior Clinical Trials Specialist is an in-house sponsor position who will oversee multiple aspects of clinical trial conduct including study start-up, document generation and review, tracking of samples, enrollment of study participants, as well as scheduling of treatment with investigational product.
- The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.
- Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, and relevant study plans and charters)
- Works with multiple contract research organizations to communicate detailed timelines and ensure that performance expectations are met
- Attends internal team and other meetings
- Provides training as necessary at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences
- Creates and reviews site feasibility assessments required for study participation
- Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations
- Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager
- Prepares metrics and updates to key deliverables for management
- Assists in the resolution of clinical trial queries for interim analysis, primary analysis and final database locks.
- Prepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team
- Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol
- Participates in the development, review and implementation of departmental SOPs and processes
- Travel 25% or more of the time
- Other duties as assigned
- Bachelor’s degree in nursing, science or health related field required with related clinical trial experience with oncology, haematology or related therapeutic area experience considered a plus
- Must be willing to travel at least 25% (possibly more)
- Ability to manage time demands, incomplete information or unexpected events,
- Must display strong analytical and problem solving skills
- Attention to detail
- Outstanding organizational skills with the ability to multi-task and prioritize
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Working knowledge of transplant patient care and apheresis collection a plus
- We are able to offer the opportunity to be part of this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering a competitive benefits package commensurate to any large corporation.