CONTRACT Clinical Study Manager
IUVO BIOSCIENCE OPERATIONS, LLC
Behavioral Health Market Context
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Qualifications
- •To perform in this role as contractor successfully, an individual must be able to perform each essential duty satisfactorily
- •The requirements listed below are representative of the knowledge, skill, and/or ability required
- •Bachelor’s Degree with a major/focus in relevant discipline or equivalent
- •Prior experience in the drug/device development space, preferably within clinical operations
- •Proficiency with Microsoft Office (Word, Excel, Outlook, Teams) and other software/programs as applicable including survey tools such as SurveyMonkey, Microsoft Forms
- •COMMUNICATION and INTERPERSONAL SKILLS
- •Ability to act as an empathetic and trustworthy leader who supports listening, constructive feedback, and open communication
- •Develop and foster peer and cross-functional relationships to maximize best practices, knowledge sharing, and team effectiveness
- •Demonstrate effective verbal and written communication skills required to interact with clinicians, clients, vendors, FDA Inspectors and internal project team members through demonstration of:
- •Excellent presentation and interpersonal skills, including clear, succinct, and timely communication
- •MATHEMATICAL SKILLS
- •Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals
- •Understand and demonstrate compliance with FDA, ICH/GCP/GDP, HIPAA, and IRB requirements/regulations
- •Ability to apply project management principles to daily activities
- •Ability to work both independently and/or collaboratively as an effective member of a team
- •Utilize sound judgement and decision-making ability
- •Possess superior client orientation skills
- •Be highly self-motivated with a strong ability to self-direct and self-initiate
- •Strong ability to manage, or seek advice in order to manage, sensitive issues effectively and proactively
- •Ability to approach all work activities and interactions with a high level of integrity
- •Possess strong analytical skills, with attention to detail and process
- •18 more items(s)
Responsibilities
- •The hours will range from 110 to 300 per month
- •The CONTRACT Clinical Study Manager (CSM) works in collaboration with the Project Manager and Sponsor on the strategy, planning, and successful execution of clinical programs
- •The CSM partners with other internal and external parties to ensure clinical trial activities and deliverables are completed on time and within budget
- •As a member of the Clinical team, the CONTRACT Study Manager is responsible for assigned clinical programs including, but not limited to, oversight of key project deliverables, resources, including CRA team, timelines, clinical trial site logistics and communications in the most cost and time effective way, while assuring quality and GCP compliance
- •The Study Manager takes accountability for operational aspects of assigned clinical study/ies and assumes varied levels of responsibility for study budget tracking, training of both CRO and site staff and the management of activities conducted by contract CRAs
- •The Study Manager also ensures trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations
- •Support and/or lead the administration, coordination and management of study activities across multiple functional groups
- •Coordinate clinical study timelines with Project Management to meet critical milestones and Sponsor corporate goals; escalate issues that may jeopardize timelines and deliverables
- •Conduct and implement required internal and site training; coordinate operational and therapeutic area training by Medical Monitor for internal study team members
- •Participate in study planning and set-up activities including vendor management, project management and the coordination of study and implementation plans
- •Oversee site identification feasibility, evaluation and selection
- •Review CRA site visit reports and take action as required with Sponsor and/or sites
- •Provide input into EDC/eCRF design and user acceptance testing, as needed
- •Manage relationship with the sponsor, CRO, investigative site staff, laboratory, pharmacy and other internal and external personnel, as applicable
- •Review study documentation for accuracy, completeness and turnaround times; solicit information to support inquiries
- •Participate in protocol review and provide input as needed
- •Create and implement study-specific plans and templates, clinical monitoring plans and report templates, and monitoring tools and documents
- •Monitor site subject recruitment activities and report progress to PM and/or project team
- •Create investigator meeting training material and participate in the presentation of IM material, participate in the planning of offsite meetings
- •Monitor the progress of studies, data flow, identifying study related trends/issues and work with Project Management to implement corrective actions when necessary
- •Provide regular updates of study progression to Project Manager and executive management
- •Develop site-facing materials as needed including logs, source documents/worksheets/checklists, study newsletters, presentations, etc
- •Create and maintain FAQ/Decision Logs
- •Work with iuvo team members and sites to create and execute recruitment plans in order to meet or exceed enrollment timelines
- •Manage the tracking and forecasting of key study metrics and deliverables
- •Develop tables, spreadsheets, charts and/or graphs for use on project calls
- •Work with the Finance department to review site payment reports for accuracy
- •Build strong rapport and relationships with internal teams, clients, and vendors
- •Successfully influence and negotiate with other stakeholders
- •Sharing ideas in a constructive and positive manner
- •Listening to and objectively considering ideas and suggestions
- •Keeping commitments
- •Keeping others informed of work progress, timetables and issues
- •Addressing problems/issues constructively to find mutually acceptable solutions
- •Respecting the diversity of our work force in actions, words, and deeds
- •Read and comprehend work instructions/SOPs and protocols and write clear concise reports
- •The physical demands described here are representative of those that must be met by a contractor to successfully perform the essential functions of this job
- •While performing the duties of this job, the contractor is regularly required to sit or stand at a desk, talk and hear
- •35 more items(s)
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