Project Manager

Job Description

Project Manager

Clinical Trials Division

Employment Type: Full Time - Onsite

Reports to: SVP of Operations

Pay Rate: Based on experience

About RDI

Research & Development Institute (RDItrials.com) is a research laboratory and biobank that serves as a Contract Research Organization to the largest In Vitro Diagnostic companies in the industry.

The Project Manager designs and executes RDI's IVD sample collection trials to ensure that agreed upon services are delivered on time and on budget, using our network of physicians and labs to achieve client satisfaction. The Project Manager will perform all job functions in accordance with RDI's standard operating procedures and policies, Good Clinical Practice guidelines and all applicable regulatory requirements.

Responsibilities

• Design and document a project plan with details for each site and any labs including details for (sites selected, # kits per site, detailed CTMS setup in Salesforce, lab logistics, shipping, etc.)
• Responsible for evaluating and communicating the impact of any risks and developing plans to mitigate these risks.
• Manage Clinical studies as Project Owner for all assigned studies, as outlined in the Clinical Studies process, with accountabilities/authorities specified in the process map including ensuring protocol and study design are feasible, develop and train team on the project plan, risk mitigation plans, CRF development, kit design with service getting from kit making team, support budget/contract negotiation with sites and service from Site Network Manager, regulatory document management, and maintaining and suggesting improvements to Clinical studies process documentation.
• Design protocols to be approved by the IRB quickly that meet client requirements, prevent unnecessary deviations, and allow for RDI internal and client flexibility.
• Define and recommend top priorities for all projects on a rolling weekly basis.
• Ensure team members supporting study activities are working on these priorities, escalating any issues or prioritization question with service providers to manager.
• Design and ensure case report forms are able to capture client requested data, allow RDI to audit, and are clear for doctors to avoid doctor errors and minimize the number of queries.
• Provide options to clients for kit materials and design.
• Develop SIV training materials to clearly define the steps of the study and how it is conducted.
• Conduct or ensure training for all relevant site staff.
• Conduct and/or ensure clinical "visits" including site qualification, clinical training/SIV, and site close outs.
• Ensure all clinical studies and sites receive IRB approval within two weeks for new submissions.
• Proactively monitor project status and address issues, potential risks, and client inquiries/requests in a timely manner, which may occasionally require a flexible work schedule/working outside of normal business hours.
• Keep track and resolve client requests as study progresses.
• Host/attend client calls on time/early especially when hosting.
• Host/support client visits and audits/inspections.
• Review each project, balancing requirements with current workload, and recommending additional resources including time or reprioritization that will help enable new studies.
• Ensure CRA are generating site payments and client invoices monthly.
• Review/approve site payments prior to submission to doctors.
• Ensure successful execution of data management activities (eCRF, manifest, test file).
• Review shipping manifests and contents of shipping containers.

Skills & Requirements

• A minimum of 5 years of industry experience and a minimum of 2 years clinical study management.
• Knowledge of accepted good clinical research practice (GCP) and procedures.
• Experience with in vitro diagnostics and/or medical device industry.
• Excellent organizational, time management, budget management, and problem-solving skills.
• Hustle: Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• This is an onsite position.