Key Responsibilities
45%
- Support the Clinical Study Lead in overseeing the cross-functional study team in the successful execution of the assigned clinical study(ies)
- Support the Clinical Study Lead in partnering with Manufacturing and Clinical Supply to provide investigational product (IP) assumptions and forecasting and collaborate cross-functionally to monitor IP preparation and testing for release
- Contribute to study protocol development including study concept, where applicable
- Support the development, management, and oversight of study timelines, metrics, and quality standards [ICH/GCP/SOPs] in collaboration with all study team members/functions
- Support the assessment, selection, management, and oversight of clinical study vendors, including CROs
- Contribute to the development, management and tracking of the trial budget providing ongoing financial reporting and forecasting
- Author, review, and approve study documents, plans, and manuals and ensure execution of activities outlined in study plans
45%
- Support and contribute to study feasibility activities
- Support site identification and selection activities
- Participate in ongoing data reviews
- Support the planning and execution of clinical Investigator meetings, study meetings, and other clinical vendor meetings.
- Review clinical monitoring reports and correspondence related to monitoring visits.
- Ensure that the Trial Master File (TMF) is set up and maintained throughout the duration of the clinical study
- Support the cultivation of relationships and effective communication between the clinical study team and external stakeholders (e.g., sites, PIs, KOLs, and vendors).
- Ensure study risks are proactively identified, managed, and mitigation strategies are implemented
10%
- May participate in site and vendor audits
- May perform periodic visits to sites and/or vendors to assess progress of studies/protocol compliance
- Participate in Clinical Operations initiatives, including the development and review of Quality Documents
Minimum Requirements/ Qualifications
- Bachelor’s degree or equivalent degrees in a scientific discipline, RN, or related field
- 5+ years of experience working in clinical research within a pharmaceutical, biotechnology, or CRO with at least 2 years in study/project management
- Successful execution of global clinical trials (Phase I-Phase III) and investigator-initiated studies
- Experience in conducting rare disease and/or gene therapy clinical studies
- Experience managing and overseeing CROs and multiple clinical vendors
- Experience in study start-up with strong knowledge of applicable computer and project management software and tools
- Excellent team management abilities with a comfort level working with senior management
- Strong attention to detail and the ability to establish priorities, schedule, and meet deadlines
- Ability to work successfully within a cross-functional team and a matrix organization
- Excellent written and oral communication skills
- Ability to establish and foster effective relationships with investigators, vendors, and internal colleagues that support and advance trial team goals and objectives
- Knowledge of current regulatory requirements and guidelines governing clinical research
- Ability to manage and communicate effectively with clinical vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints
- Must be able to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
- Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner under limited direction and on own initiative
- Available for up to 10% domestic and/or international travel
