Clinical Project Coordinator, Biotech

Job Overview
IQVIA
Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.
The Clinical Project Coordinator supports, with minimal supervision, the Project Leader (PL) and Clinical Project Manager (CPM) with project management activities to ensure all work is conducted in accordance with standard operating procedures (SOPs), policies and practices, good clinical practices (GCP), applicable regulatory requirements, and meets quality/timeline metrics. Ensure customer satisfaction is met in relation to assigned project/s.

Working hours are anticipated to be either 11:00 AM–8:00 PM (including a 1-hour break) or 11:30 AM–8:00 PM (including a 30-minute break). The exact schedule will be confirmed before your start date.
Essential Functions

• Assist in the establishment and maintenance of all project documentation including all files, records and reports according to the scope of work and standard operating procedures (SOPs).
• Assist with periodic review/audit of files for accuracy and completeness.
• Assist with the coordination and tracking of all information, communications, documents, materials, and supplies for assigned projects.
• Manage study specific eTraining and oversee compliance.
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.
• Prepare and distribute status, tracking and project finance reports, and assist the project manager(s) with budget allocation and approval of invoices.
• Organize and support project leader (PL) in managing internal study team and customer meetings.
• Take and record minutes, notes and actions at assigned meetings, distribute and follow up accordingly.
• Support the preparation of presentation materials for meetings (internal/external) and project summary data.
• Support the coordination of project team and/or customer meetings including logistics and materials required.
• Identify and escalate discrepancies in project tracking data, timesheet coding, expense data billing etc.
• Establish and manage performance dashboards, analyze event triggers and alerts and determine appropriate follow up for PL or others to act upon.
• Monitor metrics and make required updates in IQVIA systems to ensure accurate and timely reporting is available to senior management.
• Assist in the establishment and maintenance of all project documentation including all files, records and reports according to the scope of work and SOPs.
• Coordinate onboarding of new Key Members and system access.
• Assist in the training and orienting of more junior project support staff.

Qualifications

• Bachelor's Degree in life sciences or other related field required.
• Good knowledge within a specific discipline typically gained through extensive work experience and/or education.
• 3 – 4 years' experience or equivalent combination of education, training, and experience.
• Knowledge of clinical trials - basic knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Knowledge of clinical systems such as CTMS and experience with Trial Master File (TMF) filing.
• Experience with EAC reporting preferred.
• Strong written and verbal communication skills including good command of English language. Good communication and interpersonal skills.
• Good problem solving skills.
• Results and detail-oriented approach to work, delivery and output. Good planning, time management, and prioritization skills. Attention to detail and accuracy in work.
• Good software and computer skills, including MS Office applications.
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
• Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Working hours are anticipated to be either 11:00 AM–8:00 PM (with a 1-hour break) or 11:30 AM–8:00 PM (with a 30-minute break). The exact schedule will be confirmed before your start date.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more