Clinical Project Manager I - Ophthalmology

Overview

The Project Manager works closely with sites and is a liaison between Voiant, the study sponsor and the CRO for executing the study protocol with Voiant.

Responsibilities & Accountabilities

· 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:

o define training and communication plan for sponsor, CRO, and sites.

o facilitate communications and data information flow between Voiant and sponsor’s designated data management vendor to meet sponsor data delivery timelines.

o 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.

Experience

· 4-year college degree

OR

· High school diploma or equivalent and minimum 2+ years’ experience in conducting or monitoring studies at a clinical research site

OR

· High school diploma or equivalent and minimum 5+ years’ experience working in a general ophthalmic practice.

Pay: $65,000.00 - $80,000.00 per year

Benefits:

401(k)

401(k) matching

Dental insurance

Employee assistance program

Employee discount

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Professional development assistance

Referral program

Tuition reimbursement

Vision insurance

Application Question(s):

It is preferred that the candidate has previous experience with Ophthalmology, Medical Device, Pharmaceutical or the Clinical Research Industry and with regulations & standards such as GCP, FDA 21 CFR 320 and 812.

a. How many years of experience do you have?

What are some of the tools/applications you have used in your role as project manager to support study management, study timelines etc.

a. Do you have experience with tools/applications supporting CTMS and TMF maintenance?

Do you have experience in reviewing study budgets – forecasting and reconciliation, and how the scope of work translates to operational deliverables for a study?

As a project manager, you will be overseeing and guiding cross-functional teams in support of study management and deliverables and may require the PM to operate on stringent timelines and be a part of discussions that can be challenging and require conflict resolution.

a. Can you briefly describe how you would oversee deliverables impeded by cross-functional challenges and address any potential conflicts.

Are you authorized to work in the U.S without employer sponsorship assistance?

Work Location: Remote