Senior Clinical Trial Manager

October 20

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Description

• Serve as the secondary contact to address site questions, when the site Clinical Research Associate (CRA) is unavailable. • Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed. • Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements. • Proactively identify out of scope and notify the study Project Manager (PM). • Work with head of Site Operations to ensure overall quality and project services, proactive issue resolution and development of systems to standardize and improve clinical trial management practices across all functional areas. • Contribute to process improvement within Site Operations, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of sponsor deliverables. • Participate in protocol development, risk assessment, database development, and clinical study report writing. • Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters. • Develop site metrics based on the approved protocol and provide updates to the PM, as outlined in the study contract. • Work with PM and Data Manager during the EDC build process in development of eCRFs, reports, and identification of variables required to support site management and monitoring activities. • Assure proper maintenance of site required records for monitoring activities, Trial Master File maintenance, and required regulatory documents per CPC requirements. • Develop study-specific monitoring visit reports and rubrics, follow-up letter templates, and project specific site materials including Monitoring Plans, Informed Consent Form (ICF) templates, Study Procedure Manual, source worksheets and site newsletter. • Mentor CRAs and Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues. • Participate in project-related and other departmental/CPC meetings as required. • Lead the Investigational Product (IP) release process and once IP release has occurred, work with the CRAs to collect all new or expiring Investigator regulatory documents. • Participate in development of project specific training for CRAs and site staff and oversee training, as appropriate. • Participate in development of site selection materials and oversee the selection of qualified sites and Investigators for participation in research protocols. • Develop sites budgets and payment processes, including identification of EDC variables required to support site payments. • Work with sites to negotiate the study site budget. • Oversee tracking and payment process. • Train CRAs at CPC and staff at selected research sites. • Train and mentor Clinical Trial Managers on reviewing and processing monitoring visit reports and follow-up letters, completing metrics and updates, tracking site specific documents, completing study site payments and creating project specific documents. • Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring and SEEV activities. • Work closely with other team members to ensure timely resolution of site issues. • Conduct drug tracking and disposition as required by project. • Participate in the development of remote monitoring. • Oversee the remote monitoring. • Conduct independent site, site co-monitoring, and CRA evaluation visits, as needed.

Requirements

• Nursing or bachelor’s degree preferred. • A minimum of 5 years of experience in clinical research setting required. • Thorough knowledge and practice of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. • Thorough knowledge of the drug and device development process. • Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint). • Experience with clinical trial management systems to include electronic data capture, randomization management, supply management systems. • Excellent interpersonal communication skills, organizational skills and a great attention to detail. • Ability to organize and instruct staff, while promoting group effort and achievement. • Ability to lead multiple projects and operational tasks simultaneously. • Ability to complete deliverables on time and within budget while maintaining quality. • Ability to manage conflicts and resolve problems proactively, quickly and effectively. • Ability to discern priorities with minimal direction to accomplish day-to-day tasks. • Willingness to travel up to 25% of the time.

Benefits

• Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately) • 11 paid holidays • 15 - 25 vacation days based on years of service • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) • In-suite exercise and relaxation room • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics) • Flexible and remote work schedules