Senior Clinical Trial Management Specialist
Behavioral Health Market Context
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Qualifications
- •Strong oral and written communication skills, alongside excellent interpersonal abilities
- •Advanced computer skills, including proficiency in MS Office applications
- •Demonstrated ability to coordinate effectively with internal and external teams
- •Capability to proactively identify project challenges and engage the Clinical Operations Team Lead in discussions about risks
- •Awareness of country-level cultural nuances and strong interpersonal skills
- •Strong problem-solving skills and attention to detail
- •Technical expertise in data flow management and metrics
- •Willingness to travel for key company meetings when required
- •Fluency in written and spoken English
- •A minimum of 5 years' experience with direct clinical study leadership in the biopharmaceutical industry
- •Proven ability to independently supervise a clinical study from start-up to database lock and regulatory submissions
- •Having a comprehensive understanding of the study's big picture in the context of the overall program
- •Advanced experience in managing contracted resources, site monitoring, and adherence to clinical quality standards
- •Proven expertise in CRO oversight and operational management with a strong focus on detail
- •Advanced knowledge of Good Clinical Practices and current FDA regulations for IND clinical trials
- •Ability to apply GCP and regulatory knowledge to all aspects of study preparation and supervision
- •Documented experience with data safety monitoring board (DSMB) activities
- •14 more items(s)
Responsibilities
- •Overseeing all operational dimensions for the implementation of one or more clinical trials, managing activities from study start-up to database lock, and ensuring compliance with Good Clinical Practices (GCP) and relevant SOPs
- •Managing relationships with study-related service providers and acting as the primary liaison for contracted CROs, study personnel, and contract laboratories; identifying potential risks, resolving issues with CROs, and ensuring study feasibility assessments are performed as needed
- •Participating in the CRO selection process, validating the clinical scope of work, supporting outsourcing of auxiliary services, and contributing to vendor management plans while reviewing quality metrics and sharing lessons learned
- •Organizing and leading vendor kick-off meetings, team training sessions, and trial WebEx for effective trial execution
- •Overseeing the development and operational aspects of site investigator grants and grant payments according to sponsor requirements
- •Providing operational input and content to the study protocol while coordinating the quality control review process
- •Coordinating and managing investigator meetings, including agenda development, slide creation, and presenting at these gatherings
- •Facilitating CRO communications concerning site selection, IRB submissions, and planning for site initiation and close-out
- •Leading and/or supporting clinical operations team meetings, drafting agendas, recording minutes, filing them in the TMF, tracking action items, providing status updates on trial enrollment and timelines, and managing communication of risks/issues
- •Conducting comprehensive reviews of key specification documents and overseeing/participating in User Acceptance Testing (UAT) for various clinical trial systems
- •Creating and maintaining content for study-related systems and portals
- •Representing clinical operations in team meetings with other functions, contributing necessary input to key process documents
- •Reviewing and approving study-related invoices and tracking vendor contract change orders for necessary approvals
- •Providing input to the development of study-related materials such as Monitoring Plans, Data Management Plans, eCRF forms, protocols, informed consent drafts, and site instructions
- •Overseeing monitoring report reviews, protocol deviations, and data listings to ensure reliable quality data
- •Monitoring patient recruitment and progress, supporting site safety reporting, and maintaining metrics for clinical study and CRO delivery performance
- •Conducting and/or overseeing site monitoring visits for clinical trials as necessary
- •Ensuring compliance and oversight of clinical trial master files to meet regulatory and GCP quality standards
- •Providing input for maintaining appropriate documentation for adverse event safety monitoring
- •Supporting regulatory audits related to clinical executions, including coordination of responses to audit findings
- •Assisting in forecasting financial planning by evaluating subject enrollment and discontinuation rates
- •Performing other related duties as assigned
- •Completing the required training curriculum to ensure ongoing compliance
- •Accurately completing timesheets and expense reports as requested
- •Updating CV as necessary
- •Maintaining a working knowledge of and complying with Parexel processes, ICH-GCPs, and all applicable guidelines
- •23 more items(s)
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