Clinical Operations Manager

Company: Brii Biosciences
Location: Durham
Posted on: February 24, 2021

Job Description:

SUMMARY: Drives the Clinical Project strategy and deliverables by providing expert operational oversight and guidance on multiple clinical studies (phase I through IV) through day-to-day CRO and vendor management, review and monitoring of work performed, metric compliance, and development of contingency plans as needed.
DUTIES AND RESPONSIBILITIES Objectives: Understands the overall Clinical Development plan for the asset and how the study(ies) fit within the corporate objectives. Executes clinical studies by leading study operational strategy and planning in addition to overseeing execution of clinical studies.-- Oversees the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations, and Brii Biosciences SOPs), within timelines and on budget.-- Oversees CROs and other 3rd party vendors to meet Brii Biosciences obligations and business objectives and as described in ICH-GCP.--- Challenge study team to ensure timelines meet the needs of the clinical development plan-- Responsible for study budget planning and management and accountable for external spend related to study execution. -- Works closely with Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate-- Communicates study status, cost, and issues to Brii Program Lead-- Serves as an escalation point for CROs and third-party vendors managed by CROs-- Maybe responsible for one or more studies of varying complexity.-- Participates in the selection of study CRO and vendors for assigned studies-- Performs oversite monitoring visits as required to ensure ICH-GCP and protocol compliance.-- Manages study operational plan and CRO activities, including project timelines & quality of deliverables, and preparing and managing approved trial budget(s), out of scope activities throughout the life of the assigned clinical trial(s)-- Maintains frequent and meaningful contact with CROs and vendors to optimize performance and provide guidance as needed to ensure study milestones are being met.-- Contributes to the development and maintenance of cross-functional plans to ensure study specific endpoints and regulatory goals are met. -- Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials for timely execution and to meet submission goals-- Contributes to relevant study documentation including clinical protocols, statistical analysis plan, clinical study reports as well as operational plans-- Assists with protocol design and medical issue resolution-- Proactively identifies project risks and resolves with some supervision-- Participates in study data review and other review activities as assigned-- Oversees the submission of trial-related and essential documents to the Trial Master File-- Identifies and provides solutions to clinical trial issues and/or risks-- Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated-- Coordinate, provide and/or facilitate operational and therapeutic area training to internal and external clinical study team members-- Work closely cross functionally to monitor quality, timelines and timely regulatory submissions-- Provide input into non-project related activities and development of department processes, procedures, and guidelines as requested-- Mentors junior team members on clinical operations tasksQUALIFICATIONS:-- BS or Master's Degree in nursing, life science, or related field (or equivalent experience) -- Minimum of five years clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company including some time in a leadership capacity.-- Must have knowledge of clinical protocol and drug development processes with proven study planning and management skills-- Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirements -- Excellent communication, presentation, interpersonal, and change management skills, both written and spoken, with an ability to inform, influence, convince, and persuade -- Strong time management, technical and organizational skills. Ability to work independently and within a team environment. -- Knowledge of basic financial concepts as related to forecasting and budgeting. Understands project budgets. -- Must demonstrate good computer skills with high level proficiency with MS Office applications (e.g., Word, PowerPoint, XL, Project) and be able to embrace new technologies

Keywords: Brii Biosciences, Durham , Clinical Operations Manager, Executive , Durham, North Carolina