Project Manager - Clinical Trial Services

at  Thermo Fisher Scientific

JOB DESCRIPTION

As a Project Manager of Clinical Trial Services at Vestrum Health, (a division of CorEvitas), you will be primarily responsible for conducting remote and/or on-site chart reviews to identify the strongest candidates for screening by the site(s) for various trials in ophthalmology. You will be assigned duties to support study start up, including evaluation of Sponsor protocols, and will work directly with the sites to ensure client satisfaction and success. In addition, you will manage projects and interact directly with the client for regular updates.

EXPERIENCE AND QUALIFICATIONS

• High School Diploma Required, Bachelors or Associates degree preferred
• Minimum 5-years’ experience in ophthalmology/ retina required (anterior segment experience strongly preferred)
• Working knowledge of Microsoft Outlook, Word, Excel and PowerPoint required
• COA or COT preferred and at least one year as study coordinator/CCRC required

YOUR RESPONSIBILITIES WILL INCLUDE:

• Manages various Trials (based on volume)
• Manage dispatch table for assigned trials
• Attend weekly client calls, meeting minutes
• Conduct chart reviews of patients identified via Vestrum’s recruitment acceleration program (RAP) reports, or as identified by the site and approved by the Sponsor, providing clinical feedback to sites for patient eligibility status.
• Provide sites with a de-identified, cumulative list of chart review results, both eligible and ineligible, via email every 1-2 weeks
• When the system allows, send sites internal communications within their EMR to inform them of prospective candidates for the study. This should be completed at the time of the chart review.
• Conduct both initial site training and retraining on how to re-identify RAP reports.
• Manage chart review trackers by study for Sponsor/internal reporting and invoicing.
• Manage site trackers by protocol, sending weekly updates to Sponsor(s).
• Follow-up with sites to ensure that enrollment of Vestrum-identified patients is properly tracked.
• Site satisfaction: monthly phone calls and/or emails to sites, solicit feedback on service quality, Site Support Meetings PRN.
• Manage practice and contact information in HubSpot for all active RAP sites.
• Review Sponsor protocols for newly awarded trials and collaborate with Director of Clinical Trial Services and data team to design the protocol summary and programming.
• Identify important changes (e.g., following a protocol amendment) to programming summaries and submit the change(s) request with the Director of Clinical Trial Services
• Attend weekly and biweekly meetings with Sponsors, create and distribute meeting minutes.
• Attend conferences and Investigator Meetings upon request.
• Attend Internal Meetings

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.