| Job Description | Overview:
The Clinical Trials Manager / Senior Clinical Trials Manager works closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and budgets.
Position Responsibilities:
Comprehensive oversight of operational aspects of assigned clinical trials including the preparation and/or review/approval of study-related documents (e.g., Laboratory Manual, Patient Reported Outcomes, Pharmacy Manual, CRF Completion Guidelines, etc.)
Manage Clinical Research Organization (CRO) interactions including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, project master files, and data management); work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met
Participate in CRO/vendor selection process for outsourced activities
Occasionally travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs
For studies supported by internal resources, collaborate with and mentor CRAs and liaise with other functional area representatives supporting the trial
Monitor study progress on an ongoing basis, review progress and develop and implement a risk mitigation strategy as needed to ensure the study progresses according to plan
Participate in the development or review of study-related documents prepared by Clinical Science (e.g., Protocol, annual reports, reports for Data Safety Monitoring Boards) as requested
Ensure compliance with relevant regulations and guidelines by maintaining regular contact with external vendors and internal or external CRAs; complete sponsors’ review of monitoring reports; identify potential study issues and recommend/implement solutions
Maintain clinical trial infrastructure, resources, budget and timeline
Serve as a liaison and resource for investigational sites
Review site contracts and negotiate investigator budgets and manage site payments
Manage study budgets for assigned trials including timely review and processing of vendor and site invoices and delivery of reliable information related to monthly accruals for finance
Organize and manage internal team meetings, investigator meetings and other trial-specific meetings
Contribute to CRF development, edit check review and EDC system user acceptance testing; actively participate in data review and cleaning for the trial
Participate in the review and revision of departmental SOPs and processes
Maintain a working knowledge of all relevant functional area SOPs and ensure adherence in the conduct of work-related activities
Other job related duties as assigned
Job Requirements:
Excellent oral and written communication skills
Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook
Ability to work within established timelines in a fast paced environment
Excellent organizational and priority management skills
Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
Education/Experience:
BS/BA degree in Science or similar area with experience
2 - 3 years of prior experience managing clinical trials for or within the biotech or pharmaceutical industry including CRO/vendor management (4-6 years for the senior CTM role)
Experience with clinical site monitoring
Knowledge of the basic data management/biostatistics processes and prior experience with
EDC, to include CRF development and user acceptance testing
Preferred experience with Phase 1
In-depth knowledge of clinical research operations including interpretation and implementation of FDA regulations/ICH guidelines is required |
| | Company | | Celldex Therapeutics | Job Code | | State or Province | | Massachusetts | | |
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