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 IQVIA Biotech 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 IQVIA Biotech.
- Develop and implement Clinical Monitoring Plan.
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 enrolment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
Coordinate 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 sites.
Manage 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 authorization.
Manage 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 CRA.
- Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed.
- Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs.
- Assist PM in preparation of audit responses, as appropriate.
- Assist PM with preparation of information for inclusion in monthly report to client.
- 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 and Abilities
- Thorough knowledge of clinical research process.
- 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.
- Ability to work independently, prioritize and work with a matrix team environment is essential.
- Working knowledge of Word and Excel.
- Prior experience in electronic data capture (EDC) preferred.
- Able to mentor CRAs and more junior Clinical Trial Managers.
- 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.
Critical job Functions
- Ability to travel domestically and internationally.
- Very limited physical effort required to perform normal job duties.
- BS/BA (or equivalent) in one of the life sciences and a minimum of 4 years direct experience in clinical studies
- Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
- Minimum of 2 years as a successful Lead CRA or Clinical Trial Manager.
- Equivalent combination of education, training and experience.