|Location||Boston, Massachusetts, United States|
Clinical Trial Manager
Responsible for operational aspects of planning and management of site performance in accordance with departmental expectations. May act as primary liaison between in-house CRAs, field based CRAs and the Clinical Project Manager (CPM). Supports and assists Clinical Project Managers in operationalizing multiple clinical research studies.
- Participates in CRA project-specific training.
- Supports preparation and may develop materials related to the training and presentations for Investigator Meetings.
- Facilitates CRA project meetings.
- Assist in the oversight of monitoring staff including the tracking and review of monitoring trip reports and escalate any trends with respect to data quality or study conduct to the appropriate CPM.
- Track and report on progress of the study including site activation, patient enrollment and monitoring visits.
- Ensures that all sites are provided supplies in accordance with study start-up expectations.
- Identify potential risks to the enrollment targets based on feasibility analysis in collaboration with the CPM.
- Develop PSV/SIV/IMV and other training tools and training materials in support of the project.
- Assist in the review of CRO and other third party vendors invoices to ensure that work is performed in accordance with scope of work.
- Ensure that monitoring visits are performed in accordance with the protocol, monitoring plan, and applicable SOPs.
- Responsible for the development of any mass site communication as appropriate.
- Responsible for operationalizing clinical protocols at the site level and ensuring appropriate SOPs are being followed for each process, depending on the study.
- Participate in eCRF in User Acceptance Testing (UAT) and the creation of eCRF completion guidelines, and ensuring site level access to eCRFs throughout the conduct of a study.
- Work with CRAs in proactively maintaining / up-dating essential documents as required, to ensure compliance with protocol and regulations.
- Contact sites as needed for data entry/data quality concerns and alert CRA of any issues prior to the next scheduled monitoring visit.
- Assist with study start-up activities including development of the first draft of the ICF.
- Assist with the review of protocol, protocol amendments, ICF and CSR documents as required.
- Provide active mentor-ship of CTA staff to build talent across the department.
- Agenda distribution & minute taking for internal study team meetings.
- Up to 20% domestic and/or international travel may be required.
- Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred, but not required.
- Experience (2+ years) working in clinical research within a pharmaceutical company or CRO or similar organization.
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
- Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
- Ability to work successfully within a cross-functional team.
- Strong knowledge of applicable computer and project management software packages.
- Excellent written and oral communication skills.
- Ability to interact with investigators, vendors, and internal colleagues.
- Knowledge of current regulatory requirements and guidelines governing clinical research.
- Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner.