WorldCare Clinical (now Voiant) · 1 month ago
Clinical Project Manager – Ophthalmology
United States
Full-time
Remote
Mid Level
2+ years expWorldCare 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.
BiotechnologyHealthcareHealth CareMedical
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
Qualification
Required
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
Benefits
Competitive salaries
Flexible work schedules
Comprehensive health, vision, and dental insurance (FSA/HAS)
EAP, Health Advocates, and Ancillary Benefits available
Generous paid time off and holiday
401(K) with employer matching plan
Annual Incentive Plan (AIP)
Paid employer life insurance, a voluntary life and disability insurance
Tuition Reimbursement
Ongoing training and development
Internet allowance for remote workers
Company on site meals and stocked snacks
Corporate Perks Program
Community Service Opportunities
Company
WorldCare Clinical (now Voiant)
WorldCare Clinical, LLC (WCC) is a global imaging CRO that provides sponsors with extensive medical, operational and image management expertise in support of even the largest and most complex study designs.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
J
Jeffrey Schneebaum
Director of Operations, Ophthalmology & Founder
Company data provided by crunchbase