Located in beautiful Western Michigan between Grand Rapids and the shores of Lake Michigan, QST Consultations, LTD. is a full-service clinical research organization (CRO) providing full clinical operations, data management, statistical analysis support and medical writing services to the drug and device development industries. Founded in 1974, the company has collaborated with clients on many successful Phase I-III and Post-Marketing clinical trials designed to support 510(k), PMA, ANDA, and NDA submissions, along with ongoing marketing activity support. QST’s primary focus is to meet the goals of each client through personalized service and technical expertise; we currently work with a range of sponsors that extend from small start-up organizations to well-established leaders in the pharmaceutical industry.
As the company continues to grow, there is an incredible opportunity for a Clinical Project Manager to manage sponsors and vendors, deliver projects on time and within budget, and implement clinical trial activities. Our ideal candidate will report onsite in our Allendale office, with some flexibility in the schedule and work from home option.
Are you ready to join the team?
You will be responsible for:
- Providing input into and developing study related materials
- Ensuring quality data are delivered by reviewing monitoring reports, protocol deviations and data listings for sponsored studies
- Coordinating with clinical team on site selection, IRB submissions, site initiation and close-out planning
- Coordinating with Data Management, Statistics and Medical Affairs on the execution of project deliverables
- Managing tracking study metrics
- Supporting safety reporting and IRB submissions and maintaining and reporting metrics for clinical site performance
- Performing and overseeing site monitoring visits for clinical trials
- Coordinating the negotiation of site budgets within guidelines and providing oversight for site payments per contracts
- Ensuring compliance with required regulatory and GCP quality standards and consistency with SOPs by providing oversight to staff maintaining clinical trial master files
- Participating in sponsor audits
- Participating in business development activities
- Planning, scheduling, and tracking project timelines, deliverables, and milestones
- Assessing and determining need for additional staffing
- Tracking and reporting project team hours and expenses and managing project budgets
- Serving as a mentor and line manager to other QST clinical personnel
- Have a bachelor’s degree with a minimum of five (5) years of clinical study management experience in bio-pharmaceutical industry, three (3) years of which as a clinical study lead or a project manager
- Be knowledgeable of pharmaceutical development, regulatory requirements, guidance, and Good Clinical Practice (GCP)
- Have proven experience in leading cross-functional teams, managing multiple projects, and meeting goals and metrics
- Be self-disciplined, able to settle well into established systems and structures, and always comply with the rules
- Be observant and reflective with high level of critical thinking
- Demonstrate exceptional leadership by building trust, developing competence, and transferring learning
- Have exceptional communication skills and ability to give difficult feedback and deliver sensitive information
- Be willing to travel up to 20% of time including domestic and international travel
Recognized as a top company to watch in Michigan, QST is a small employee-owned company that has been making a big impact in the CRO industry over the last 40 years. If you desire a rewarding career where you can make a difference, we encourage you to apply today!