Clinical Trial Manager (Contract)

Clinical Trial Manager Job Summary:Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works on projects of low to moderate complexity and as part of a team of CTMs.Essential Functions:Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements.Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. department.May communicate with study sites regarding issues such as protocol, patient participation, case report form completion, and other study-related issues.May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that essential document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees.May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.Manages all aspects of monitoring operations and quality for assigned studies, ensuring compliance with ICH GCP and applicable local regulationsDevelops clinical tools and study plans, collaborates with client CSO (to include but not limited to CCSLs) and leads team meetings to maintain timelines, resources, and quality. Serves as clinical subject matter expert for protocol and point of escalation for site manager as applicableMay include regional coordination with regional CMLs.Ensures timely deliverables, monitors trials, communicates with study sites, coordinates start-up activities, addresses regulatory requirements and provides input on forecast estimates and resource management.Completes trip report reviews in compliance with study plan timeline.Issue escalation per plan, responsible for identifying and reporting site performance issues, trend analysisMay perform accompanied site visits with site manager and may attend meetings with Sponsor to discuss but not limited to country/region start up progress, trending and issue identification/escalation, and general site/country updates.Generate monitoring plan and trip report completion annotationsEducation and Qualifications:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).Monitoring or Study Management and Oversight ExperienceFully remote position, M-FFlexibility to work east coast or west coast hours requiredBlinded CTM experience requiredPrior neurology therapeutic experience required, rare-disease experience also preferredKnowledge, Skills, and Abilities:Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teamsGood planning and organizational skills to enable effective prioritization of workloadSolid interpersonal and problem-solving skills to enable working in a multicultural matrix organizationCapable of working effectively in a changing environment with complex/ambiguous situationEffective oral and written communication skills, including English language proficiencyCapable of evaluating workload against project budget and adjusting resources accordinglySound financial acumen and knowledge of budgeting, forecasting and fiscal managementStrong attention to detailSolid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.To find out more about Real, please visit