IQVIA Clinical Trial Manager, Oncology ( Homebased, Nationwide) - Novella Clinical in Morrisville, North Carolina
Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by Novella Clinical and its clients.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Responsible for all activities related to implementation and execution of clinical studies that include:
Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP.
Serve as client advocate within Novella.
Develop and implement Clinical Monitoring Plan.Team Duties/Responsibilities:
Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:
Coordinate site management activities
Site identification, recruitment, and selection
Regulatory document collection and review
Overall scheduling and management of all site visits
Develop site/monitoring tools and training materials
Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutionsCoordinate and oversee daily operations of clinical monitoring team:
Set and enforce project timelines with the assigned study team
Coordinate remote review of clinical data within EDC system
Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract
Review and approve trip reports and follow-up letters within required timeframe
Schedule and manage weekly CRA project team meetings
Ensure CRAs assigned to team receive therapeutic and project-specific training
Manage quality and regulatory compliance among clinical monitoring team and investigational sitesManage project milestones and proactively address deficiencies:
Attend and provide information at monthly projections meetings
Attend and provide information at weekly client teleconferences/team meetings
Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorizationManage CRA performance:
Define and implement functional standards, goals, and expectations with clinical monitoring team.
Serve as CRA mentor and perform accompanied field assessment visits as required
Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRADocumentation Duties/Responsibilities:
Assure that the appropriate Novella and/or sponsor SOPs are followed
Ensure all project documentation is appropriately filed per Novella SOPs
Assist PM in preparation of audit responses, as appropriate
Assist PM with preparation of information for inclusion in monthly report to clientBudget/Contract Duties/Responsibilities:
Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions
Define the scope of work with the client and clinical monitoring team
Assist PM in identifying and generating changes in scope and notify client of potential changes in scope
Review and approve CRA travel expenses and time sheets KNOWLEDGE, SKILLS & ABILITIES:
Thorough knowledge of clinical research process.
Prior experience as a Clinical Research Associate.
Strong communication skills (verbal and written) to express complex ideas.
Excellent organizational and interpersonal skills.
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Ability to manage multiple priorities within various clinical trials.
Ability to reason independently and recommend specific solutions in clinical settings.
Understanding of basic data processing functions, including electronic data capture.
Working knowledge of current ICH GCP guidelines and applicable regulations.
Able to mentor CRAs.
Able to qualify for a major credit card.
Valid driver’s license; ability to rent automobile.
Willingness and ability to travel domestically and internationally, as required
BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years direct experience in clinical studies or equivalent level of education and experience.
Previous experience in personnel management within a scientific/clinical environment preferred.
At least 2 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis.
Excellent verbal and written communication skills.
Ability to work independently, prioritize and work within a matrix team environment is essential.
Working knowledge of Word and Excel.
Prior experience in electronic data capture (EDC) preferred.
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