IQVIA Clinical Trial Manager (Dermatology,Home-based) - Novella Clincial in Boulder, Colorado
Novella Clinical is looking for Perm Clinical Trial Managers (CTM) to join our growing team. The ideal candidate can be office based in one of our Novella offices or home-based. Candidates must have CRO Dermatology experience.
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 programtargets for clinical monitoring staff and assure work is documentedwithin contracted project scope. Communicate and document all interactionswith client as required by SOP.
Serve as client advocate within Novella.
Develop and implement Clinical Monitoring Plan.
Responsible for assuring needs of clinical sites aremet 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 entryat sites and proactively interface with clinical monitoring team and client toidentify solutions
Coordinate and oversee daily operations of clinical monitoring team:
Set and enforce project timelines with the assignedstudy team
Coordinate remote review of clinical data within EDCsystem
Oversee monitoring visit schedule to ensure compliancewith frequency set forth in contract
Review and approve trip reports and follow-up letterswithin required timeframe
Schedule and manage weekly CRA project team meetings
Ensure CRAs assigned to team receive therapeutic andproject-specific training
Manage quality and regulatory compliance among clinicalmonitoring team and investigational sites
Manage project milestones and proactively address deficiencies:
Attend and provide information at monthly projectionsmeetings
Attend and provide information at weekly clientteleconferences/team meetings
Assist Project Manager in identifying Out of Scopeactivities and assuring that such activities do not begin until theclient provides authorization
Manage CRA performance:
Define and implement functional standards, goals, andexpectations with clinical monitoring team.
Serve as CRA mentor and perform accompanied fieldassessment visits as required
Participate in the performance appraisal program byproviding timely and accurate feedback regarding the performance ofeach respective CRA
Assure that the appropriate Novella and/or sponsor SOPsare followed
Ensure all project documentation is appropriately filedper Novella SOPs
Assist PM in preparation of audit responses, asappropriate
Assist PM with preparation of information for inclusionin monthly report to client
Assist PM in review of project budgets, monitoringcosts, potential overruns and propose/implement cost effective solutions
Define the scope of work with the client and clinicalmonitoring team
Assist PM in identifying and generating changes inscope 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) toexpress complex ideas.
Excellent organizational and interpersonal skills.
Positive attitude and ability to interact with alllevels of staff to coordinate and execute study activities.
Ability to manage multiple priorities within variousclinical trials.
Ability to reason independently and recommend specificsolutions in clinical settings.
Understanding of basic data processing functions,including electronic data capture.
Working knowledge of current ICH GCP guidelines andapplicable 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 andinternationally, as required.
MINIMUM RECRUITMENT STANDARDS:
BS/BA (or equivalent) in one of the life sciences witha minimum of 4 years direct experience in clinical studies orequivalent level of education and experience.
Previous experience in personnel management within ascientific/clinical environment preferred.
At least 2 years as a Clinical Monitor/CRA, as well asexperience in data handling or analysis.
Excellent verbal and written communication skills.
Ability to work independently, prioritize and workwithin a matrix team environment is essential.
Working knowledge of Word and Excel.
Prior experience in electronic data capture (EDC)preferred.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Ability to travel domestically and internationally
Very limited physical effort required to perform normaljob duties
EEO Minorities/Females/Protected Veterans/Disabled
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