Clinical Trial Manager, Medical Device (Home-based - Nationwide) - Novella Clinical
Responsiblefor the successful planning, implementation and execution of contractedclinical monitoring activities. Functionally responsible for all clinical monitoring team membersthroughout the duration of each clinical trial. Assures clear client and internal team communication, processdocumentation, and compliance with Good Clinical Practices and procedures setforth by Novella and its clients.
ESSENTIAL JOB FUNCTIONS,DUTIES AND RESPONSIBILITIES:
Responsiblefor all activities related to implementation and execution of clinical studiesthat include:
- Workwith Project Manager (PM) to define program targets for clinical monitoringstaff and assure work is documented within contracted project scope.Communicate and document all interactions with client as required by SOP.
- Serveas client advocate within Novella.
- Developand implement Clinical Monitoring Plan.
Responsiblefor assuring needs of clinical sites are met by facilitating clinicalmonitoring processes, including:
Coordinatesite management activities:
- Siteidentification, recruitment, and selection.
- Regulatorydocument collection and review.
- Overallscheduling and management of all site visits.
- Developsite/monitoring tools and training materials.
- Reviewand identify trends in enrollment and data entry at sites and proactivelyinterface with clinical monitoring team and client to identify solutions.
Coordinateand oversee daily operations of clinical monitoring team:
- Setand enforce project timelines with the assigned study team.
- Coordinateremote review of clinical data within EDC system.
- Overseemonitoring visit schedule to ensure compliance with frequency set forth incontract.
- Reviewand approve trip reports and follow-up letters within required timeframe.
- Scheduleand manage weekly CRA project team meetings.
- EnsureCRAs assigned to team receive therapeutic and project-specific training.
- Managequality and regulatory compliance among clinical monitoring team andinvestigational sites.
Manageproject milestones and proactively address deficiencies:
- Attendand provide information at monthly projections meetings.
- Attendand provide information at weekly client teleconferences/team meetings.
- AssistProject Manager in identifying Out of Scope activities and assuring that suchactivities do not begin until the client provides authorization.
- Defineand implement functional standards, goals, and expectations with clinicalmonitoring team.
- Serveas CRA mentor and perform accompanied field assessment visits as required.
- Participatein the performance appraisal program by providing timely and accurate feedbackregarding the performance of each respective CRA.
- Assurethat the appropriate Novella and/or sponsor SOPs are followed.
- Ensureall project documentation is appropriately filed per Novella SOPs.
- AssistPM in preparation of audit responses, as appropriate.
- AssistPM with preparation of information for inclusion in monthly report to client.
- AssistPM in review of project budgets, monitoring costs, potential overruns andpropose/implement cost effective solutions.
- Definethe scope of work with the client and clinical monitoring team.
- AssistPM in identifying and generating changes in scope and notify client ofpotential changes in scope.
- Reviewand approve CRA travel expenses and time sheets.
KNOWLEDGE, SKILLS &ABILITIES:
- Thoroughknowledge of clinical research process.
- Priorexperience as a Clinical Research Associate.
- Strongcommunication skills (verbal and written) to express complex ideas.
- Excellentorganizational and interpersonal skills.
- Positiveattitude and ability to interact with all levels of staff to coordinate andexecute study activities.
- Abilityto manage multiple priorities within various clinical trials.
- Abilityto reason independently and recommend specific solutions in clinical settings.
- Understandingof basic data processing functions, including electronic data capture.
- Workingknowledge of current ICH GCP guidelines and applicable regulations.
- Ableto mentor CRAs and more junior Clinical Trial Managers.
- Ableto qualify for a major credit card.
- Validdriver’s license; ability to rent automobile.
- Willingnessand ability to travel domestically and internationally, as required.
- BS/BA(or equivalent) in one of the lifesciences with a minimum of 4 years direct experience in clinical studies orequivalent level of education and experience.
- Minimumof 4 years as a Clinical Monitor/CRA, as well as experience in data handling oranalysis.
- Minimumof 2 years as a successful Lead CRA or Clinical Trial Manager.
- Excellentverbal and written communication skills.
- Abilityto work independently, prioritize and work with a matrix team environment isessential.
- Workingknowledge of Word and Excel.
- Priorexperience in electronic data capture (EDC) preferred.
CRITICAL JOB FUNCTIONSIN ACCORDANCE WITH ADACRITERIA:
- Abilityto travel domestically and internationally
- Verylimited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
- * Position requires cardiac/aortic surgery and/orvascular surgery experience.
- 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.
- 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.
- Excellent verbal and written communication skills.
- 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.
EEO Minorities/Females/Protected Veterans/Disabled
Back to top