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Summary of Responsibilities:
Duties include diverse coordination and administrative tasks and activities. May organize multiple processes, procedures, or programs.
Responsible for reviewing and supporting the logistics and operational management of Business Operations departmental processes.
Assists with the identification of challenges and resolutions, process improvement initiatives.
Provides analytical and specialized support to relieve and assist executives, line and staff managers of complex details and advanced coordination and administrative duties. This may include the coordination, tracking and management of budgets, metrics, vendor compliance/risk, activities required for new-hires and leavers, and coordination of vendor/client/team meetings, for example.
Assist in the processing, analyzing and graphical display of data related to Business Operations activities to support the delivery to established goals.
Act as contact for Business Operations functional leadership to support specific ad hoc activities within their teams requiring coordinated support.
Serve as the Business Operations Core Matrix Owner to manage the departmental Core Training Matrix and track compliance to any core/mandatory training requirements.
Prepares high quality correspondence, presentations and reports, letters, and other documents. Contacts company employees at all organizational levels to gather information and prepare reports.
Effectively maintains confidentiality of critical documents.
Effectively manages complex assignments and projects where independent action, within guidelines, and a high degree of initiative are required in resolving problems and developing recommendations. May handle special projects and execute research and data analysis tasks.
Acts independently to determine methods and procedures on new assignments.
Coordinates and compiles information required for Business Operations Monthly Reporting.
Oversees and arranges logistical and hospitality aspects of meetings, including scheduling, preparing agendas, slides, and minutes as well as making necessary business travel arrangements, compiling and distributing materials, arrangements with presenters, recording and distribution of meeting minutes, action items. Keeps track of RSVPs for events and meetings and proactively ensuring that things are not overlooked. Facilitates / performs “host” duties for WebEx / Blue Jeans meetings.
Arrange and oversee administrative aspects of training for Business Operations, including updating staff details in relevant databases, maintaining business-wide and departmental training matrices and assigning these to the online training portal. Pulls training reports to ensure training is up to date and to identify any training deficiencies or requirements.
Manages and maintains filing system, ensuring compliance with Records Retention policies and protocols. Includes tracking and uploading CVs, job descriptions and organizational charts regularly.
Maintains a wide variety of departmental trackers, departmental distribution lists, business continuity contact list, department SharePoint/Yammer sites, etc.
Creates and maintains department newsletter(s).
Support the day-to-day operational management and execution of assigned clinical trials, ensuring activities are completed in accordance with study timelines, applicable regulations, and established quality standards.
Maintain accurate and up-to-date clinical trial information within study tracking tools, databases, and operational systems, providing regular updates to study teams and stakeholders.
Assist with the development, maintenance, and coordination of study-specific plans, essential trial documents, and operational processes throughout the study lifecycle.
Support study startup, maintenance, and closeout activities, including site feasibility, site activation readiness, study system setup, and operational tracking.
Coordinate and facilitate communications with investigative sites, investigators, study vendors, and internal cross-functional teams to support study objectives and deliverables.
Assist with vendor onboarding, oversight, and coordination activities, including tracking deliverables, issue resolution, and communication of study requirements.
Ensure the quality, completeness, and inspection readiness of Trial Master File (TMF) documentation by coordinating document collection, review, filing, and compliance activities.
Support clinical data review, data cleaning, and study metric tracking activities, assisting with the identification and resolution of operational and data-related issues.
Coordinate investigator, site, and study team training activities, including management of study-specific training documentation and compliance tracking.
Contribute to patient-focused initiatives and trial engagement strategies designed to support participant recruitment, retention, and overall study success, where applicable.
And all other duties as needed or assigned
Qualifications (Minimum Required):
University/college degree - Degree level education in Life Sciences, or Business Studies-or related (equivalent) experience.
Minimum of three years relevant coordination/administration experience in clinical research setting in a pharmaceutical company/CRO
Valid Driver’s License
Experience (Minimum Required):
Minimum of 3 years of project coordinator, project administrator, or executive administrative assistant or related experience.
Ability to interact consistently professionally with all levels of individuals internally and externally.
Ability to manage time and meet deadlines independently and efficiently.
Advanced proficiency in Microsoft Office Suite of Products (Word, Excel, PowerPoint, Outlook) and Internet. Ability to use various applications, including running reports, spreadsheets, email and the internet.
Outstanding communication, presentation and keyboarding skills required.
Navigate effectively in a team based corporate environment, coordinate activities among departments and outside parties.
Solid prioritization, organization, and time management abilities. Strong attention to detail.
Utilizes critical thinking skills to independently analyze problems, determines approach, identifies potential solutions, and utilizes experience and judgment for issue resolution, within guidelines.
Excellent oral/written communication with team members, external clients, vendors, and management (phone, fax, letter, e-mail). ¨ Understands internal and external customers’ requirements and expectations and provides consistently outstanding customer service.
Demonstrated understanding of clinical research processes, including study startup, conduct, monitoring support, maintenance, and closeout activities.
Working knowledge of ICH-GCP guidelines, clinical research regulations, and industry standards.
Knowledge of clinical trial documentation requirements, Trial Master File (TMF) management, and quality compliance practices.
Experience working with clinical trial management systems, electronic trial master files, and study tracking tools preferred.
Physical Demands/Work Environment:
Ability to sit for extended periods and operate a vehicle safely.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Regular and consistent attendance.
Varied hours may be required.
Target Pay Range: $62-70K based on experience and level
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