TFS Clinical Research Manager in Princeton, New Jersey
The Clinical Research Manager (CRM) is part of Clinical Operations Unit within TFS Clinical Development Services and will function operationally as a member of a Project Team being responsible of coordinating and overseeing the country and site management activities during study conduct, according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations.
The CRM will be responsible for certain aspects of project activities which may include country and site tracking, monitoring plans, review of monitoring reports and study monitoring resources management.
The CRM can be also appointed as Clinical Operations Staff Line Manager being responsible for providing oversight and support in meeting quality standards, operational and financial deliverables of the assigned staff.
ESSENTIAL JOB FUNCTIONS
Project oversight and responsibility over clinical operations deliverables
Responsible for overseeing all aspects of monitoring and site Management activities ensuring compliance with ICH/GCP guidelines, SOPs and protocol requirements.
Lead, manage and guide CRAs being responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables.
Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.
Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.
Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.
Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.
Perform co-monitoring visits as part of the monitoring team quality oversight.
Review and approve site visit reports (PSV, SIV, MV and COV) with agreed and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up.
Review CRA Site Visits calendar ensuring monitoring visits (both remotely and on site) are being scheduled and conducted following monitoring plan frequency.
Update the Project Manager with status of sites and countries and ensure a proper escalation of any issue detected at site/country level.
Ensure documents remain current during the course of the trial and ensure proper maintenance of Trial Master File being responsible of QC when delegated by Project Manager.
Review CTMS to ensure country, site and subject information is recorded properly and on a regular basis.
Provide input to project manager about activities time registration and consumption ensuring appropriate revenue recognition and revenue forecasting.
Participate in Investigators Meetings and present monitoring requirements and deliverables when requested.
May also be appointed as primary CRA in some sites and conduct all stages of site monitoring (feasibility, pre-study, initiation, interim, and close-out).
Actively contribute to the organization and development of initiatives and processes to enhance the work at TFS.
For local studies, CRM may be assigned as Project Manager being in charge of customer liaison, project budget management, vendor selection and management and any other additional tasks described in Project Manager Job Description.
-Clinical Operations staff management, resourcing and development
Line management of assigned staff within Clinical Operations
Participate in resource planning and staff allocation discussions to ensure that project teams are appropriately resourced during all phases of a project
Ensure assigned staff achieve expected quality compliance standards by providing appropriate oversight
Collect and analyze delivery, productivity and performance metrics
Provide pro-active guidance and direction to assigned staff around site selection, site management, site monitoring, site close out and customer management to assist in service delivery and professional development
Support staff with resolution of significant site issues and development of recruitment strategies and contingencies
Provide technical expertise and Clinical Operations support to assigned staff
Ensure staff are appropriately qualified and trained by providing input to training plans, coaching and mentoring of assigned staff and assisting in the delivery of training
Together with the Director, Clinical Operations to ensure assigned budgets are managed, profitability is maintained and invoicing is performed on time and in accordance with the scope of work
Identify and escalate issues as appropriate within the organization
Participate in global process improvement initiatives
Degree in clinical, science or health related field
4+ years of clinical research experience, preferably as CRA, including relevant on-site monitoring experience.
Able to work in a fast paced environment with changing priorities
Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas
Possess the understanding of Good Clinical Practice regulations, ICH guidelines
Ability to work independently as well as in a team matrix organization and multiple projects
Excellent written and verbal communication skills as well as computer skills
Excellent organizational and Line Management skills
Ability and willingness to travel up to 20-30%
Benefits discussed during the interview process