Clinical Project Manager – Ophthalmology

WorldCare Clinical (now Voiant) is a company focused on clinical research. They are seeking a Clinical Project Manager who will act as a liaison between Voiant, the study sponsor, and the CRO to execute study protocols effectively.

Responsibilities:

• Consistently performs duties within established Policies, Standard Operating Procedures, Work Instructions, and Study Specific Procedures in accordance with current GxP standards and applicable regulations (e.g., Good Clinical Practices, Good Documentation Practice, 21 CFR Part 11/Annex 11, MHRA, GDPR, HIPPA)
• Reviews Project Management Plan and with sponsor and CRO to:
• Define training and communication plan for sponsor, CRO, and sites
• Facilitate communications and data information flow between Voiant and sponsor’s designated data management vendor to meet sponsor data delivery timelines
• Facilitate communications and data information flow between Voiant and sponsor’s designated CRO to maximize study site performance
• Provides online access and training to sponsors, CRO and data/safety management on content with Voiant systems
• Tracks certification progress at study sites to meet sponsor timelines by monitoring Voiant Study Forms and addressing uncertified site issues with appropriate CRO and Voiant staff members
• Assists and advises Sponsor/CRO with site selection as requested
• Conducts training for sites, sponsors and CROs on Voiant study protocol specific site procedure manuals and other Voiant processes as determined by the Director of Global Services
• Monitors content of the company’s Status Report with sponsor and CRO to obtain forms and images from sites within timelines needed to generate company data for all protocol analysis time points
• Provides ongoing study site compliance matrices to sponsor and CRO; identifies sites needing re-training or re-certification on company study protocol procedures on as-needed basis and addresses them with appropriate Voiant and CRO staff members to obtain resolution
• Assists CRO in monitoring site staff / contact information and verifying that required site Voiant certifications remain current in Voiant STUDY FORMS throughout the study
• Assists sites, sponsor, and CRO in tracking queries to resolution in timely manner via the company status report
• Coordinates technical staff support with study sites and tracks technical issues to resolution in support of the Project Manager
• Meets with Sponsor and CRO at regular intervals to maintain site compliance in study via the Voiant Status Report, adjunct reports, and company procedure manuals when requested by the Director of Global Services
• Provides periodic newsletter or supplemental study information about Voiant, site performance, etc., to sponsor and CRO on regular basis when requested
• Attends interim and recurring teleconferences and webcasts related to study training and management when requested by the Director of Global Services
• Coordinates details of the company’s data delivery method and schedule between Voiant data team and sponsor / CRO data team for ad hoc data transfers
• Develops and implements study closure plan with sponsor, CRO, and sites
• Maintains an updated CV on file with the Quality Assurance team
• Maintains current all assigned training and training documentation
• Answers incoming phone calls from sponsors, CROs, and sites and redirect calls as appropriate
• Monitors inflow of screening/baseline and follow-up study subject forms and images
• Performs QC check of incoming forms and images and issues queries as needed
• Archives pertinent study specific documents in M Files
• Executes internal protocol change control document with company staff when an active study Amendment is received
• Performs other duties and responsibilities as assigned

Requirements:

• 4-year college degree
• High school diploma or equivalent and minimum 2+ years' experience in conducting or monitoring studies at a clinical research site
• High school diploma or equivalent and minimum 5+ years' experience working in a general ophthalmic practice