Job Title: Clinical Project Manager Location: Rockville, MD Employment: Direct, full-time PRIMARY RESPONSIBILITIES: Develops and maintains the clinical trial deliverables including timelines, budgets, and resource requirements within a therapeutic area Attends and supports the clinical sub team Provides matrix management of cross functional representatives to manage clinical execution deliverables Defines and manages accountabilities for CTT team members and supports the CST as required Reviews and refines clinical operations plans for each study Develops and constructs content for risk mitigation plans related to the study to ensure clinical trials are on time and within budget Implements clinical trial ensuring that clinical trials are conducted in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets Partners with clinical development and cross functions to draft the Clinical Protocols, Investigator's Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs), and manages timelines for completion of these documents. May lead selection process for outsourced activities, Leads the selection of specialty vendors (if needed) including development of scope of services agreements, budgets, and plans and timelines Manages CRO/vendor agreements, ensuring that change orders and budgets meet clinical operations specifications Reviews invoices for accuracy compared to operational plans, budgets, and work known to be performed by CRO/vendors Lead ongoing review of data to ensure quality and consistency through study execution Manages CRO/vendors to achieve goals and ensures that performance expectations are met Responsible for working with the CRO to plan everything from early engagement for protocol feedback to database lock. Participates in patient identification activities and the development of patient recruitment plans and back-up plans Identifies, recruits, and approves clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership Ensures that all supportive study-related documents are completed (eg Monitoring Plan, IXRS, Study Reference Manual, Laboratory Manual, Pharmacy Manual, CRF Completion Guideline, etc.) Ensures that all monitoring activities and processes are complete, including training of internal and external resources, and are compliant with SOPs and GCP/ICH/regulatory guidelines Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues Manages internal supporting staff to ensure that all activities are moving according to trial timeline Recommends and implements innovative process ideas that impact clinical trials and/or clinical program management Participates in the development of clinical operations quality systems, including SOPs, document management, clinical operations personnel training, and quality control processes Contributes to wider organizational goals and/or activities as assigned Mentors clinical operations personnel in clinical trial execution Supports the clinical operations lead and clinical trial team by performing other tasks as needed SKILLS, KNOWLEDGE AND ABILITIES REQUIRED: Bachelor's degree required; degree with a focus in biological science Minimum of 5-8 years' progressive experience in clinical operations with thorough understanding of cross functional clinical processes including clinical supply, data management, biostatistics, and medical writing At least 3-5 years in clinical project management is required Ability to execute clinical trial from protocol writing through clinical study report completion independently Previous trial execution experience in complex indications preferred Global study execution and experience with various health and ethics agencies required