Senior Project Manager, Assay Development

NeoGenomics; Mississippi; Remote; USD 90,000 - 120,000; Full time

Job summary

NeoGenomics is seeking a motivated Senior Project Manager for a full-time remote role. You will collaborate with teams to manage product development projects, ensuring adherence to specifications, schedules, and budgets. Join a company dedicated to improving patient care and advancing your career through extensive training and a supportive culture.

Benefits

401k Match

Employee Stock Purchase Program

Tuition Reimbursement

16 Days Paid Time Off

Wellness Courses

Qualifications

• 7+ years of project management experience in Medical Device or IVD industry.
• Experience managing molecular diagnostic assay projects compliant with CAP/CLIA and FDA.

Responsibilities

• Serve as primary contact between sponsors and NeoGenomics.
• Develop Project Charters based on Statements of Work.
• Maintain comprehensive project documentation.

Skills

Project Management

Communication

Collaboration

Analytical Skills

Problem Solving

Education

Bachelor’s Degree

MS or PhD in Life Sciences

Job description

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to join a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to explore this opportunity.

We believe in career development and empowering our employees. Not only do we provide internal career coaching, but we also offer many training opportunities to expand your knowledge base. Our benefits are highly competitive, including various HMO and PPO options, a company 401k match, an Employee Stock Purchase Program, tuition reimbursement, leadership development, and starting employees off with 16 days of paid time off plus holidays. We also offer wellness courses and maintain highly engaged employee resource groups. Join the Neo team and become part of our exceptional World Class Culture!

NeoGenomics is seeking a Sr. Project Manager who is eager to learn and contribute to our company's growth. This is a full-time, remote position.

Here's why you'd want to work at NeoGenomics:

We promise to provide you with a purpose-driven mission where you can help save lives by improving patient care through your exceptional work. Together, we aim to become the world's leading cancer reference laboratory.

Position Summary:

The Senior Project Manager will collaborate with internal cross-functional teams and external partners to develop products according to specifications. Responsibilities include directing and planning product development projects, managing schedules and budgets, and ensuring consistent practices throughout the project lifecycle.

Responsibilities:

1. Serve as the primary contact between sponsors and NeoGenomics, maintaining positive relationships and resolving project challenges collaboratively.
2. Adhere to all internal SOPs for clinical trial study management.
3. Develop Project Charters based on project Statements of Work and input from sponsors and project teams.
4. Proactively identify and address project risks from the outset and as they arise.
5. Lead kickoff calls with sponsors and project teams, with regular communication.
6. Communicate relevant project information effectively to stakeholders, including status, risks, and needs.
7. Create and maintain accurate forecasts of testing volume and revenue.
8. Maintain comprehensive project documentation, including checklists, communication plans, data records, agreements, study binders, training records, financial records, CAPA and audit records, and meeting notes.

Experience, Education, and Qualifications:

• Bachelor’s Degree required; an advanced degree (MS, PhD) in life sciences, engineering, or related field is preferred.
• 7+ years of project management experience, preferably in the Medical Device or IVD global industry, with experience in product development, logistics, and product deployment.
• Experience working with cross-functional teams, including software engineers, bioinformaticians, and wet lab scientists.
• Experience managing molecular diagnostic assay/genetic test development and validation projects under design control, compliant with CAP/CLIA and FDA regulations.
• Alliance and collaboration management experience is preferred.
• Knowledge of clinical diagnostics.
• Ability to develop project components and timelines with excellent communication and collaboration skills.
• Strong interpersonal skills to build relationships and gain stakeholder agreement.
• Exceptional analytical and strategic problem-solving skills.
• Ability to work independently and collaboratively in a dynamic environment.