Offer summary

Qualifications:

Bachelor’s Degree required, advanced degree (MS, PhD) in life sciences, engineering, or related field preferred., 7+ years’ project management experience in Medical Device or IVD Global industry., Experience managing molecular diagnostic assay development projects under design control and compliance with regulations., Strong communication, collaboration, and analytical skills..

Key responsibilities:

Serve as the primary point of contact between sponsors and NeoGenomics, maintaining positive relationships.

Develop Project Charters based on project Statements of Work and input from teams.

Proactively identify and address project risks, leading kickoff calls with stakeholders.

Create and maintain accurate project documentation and forecasts of testing volume and revenue.

Job description

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 dive deeper into this opportunity.
We believe in career development and empowering our employees. Not only do we provide career coaches internally, but we offer many training opportunities to expand your knowledge base! We have highly competitive benefits with a variety HMO and PPO options. We have company 401k match along with an Employee Stock Purchase Program. We have tuition reimbursement, leadership development, and even start employees off with 16 days of paid time off plus holidays. We offer wellness courses and have highly engaged employee resource groups. Come join the Neo team and be part of our amazing World Class Culture!

NeoGenomics is looking for a Sr. Project Manager who wants to continue to learn in order to allow our company to grow. This is a full time, remote position.

Now that you know what we're looking for in talent, let us tell you why you'd want to work at NeoGenomics:

As an employer, we promise to provide you with a purpose driven mission in which you have the opportunity to save lives by improving patient care through the exceptional work you perform. Together, we will become the world's leading cancer reference laboratory.

Position Summary:

The Senior Project Manager will work closely with internal cross-functional teams and external partners to develop products to desired specifications. This individual will be responsible for directing and defining the planning and execution of product development projects including but not limited to schedules, budgets, and ensuring consistent practices throughout the project life cycle.

Responsibilities:

Primary point of contact between sponsors & NeoGenomics. Establish & maintain a positive working relationship with sponsor, cooperate to resolve project challenges.
Adhere to all internal SOPs for clinical trial study management
Develop Project Charters (a.k.a. Study Specific Protocols, or SSPs) based on project Statements of Work (SOWs) and input from sponsors & project teams.
Proactively identify project risks & address systemically at project outset. Take quick action to address new risks as they are identified.
Initiate & lead kickoff calls with sponsors & project teams, communicate regularly.
Develop and utilize effective sustainable means of communicating relevant information to stakeholders such as project status, risks, and needs.
Create & maintain accurate forecasts of testing volume & associated revenue.
Establish & fastidiously maintain project documentation including but not limited to Project Initiation Checklists, Communication Plans, LIMS Master Project Data, Data Transfer Agreements, Specimen Tracking Forms, study binders (hardcopy and/or electronic), study personnel training records, Financial Force records, CAPA & audit records, Site Personnel Signature & Responsibility Logs, billing evidence, Study Final Reports, Study Closure Forms, and meeting notes / actions.

Experience, Education and Qualification:

Bachelor’s Degree required, advanced degree (MS, PhD) in life sciences, engineering, or related field preferred
7+ years’ project management experience preferably in Medical Device or IVD Global industry, specifically engaged in product development systems, logistics and deployment of products with commercial role out experience
Experience working in cross-functional teams, especially with software engineers, bioinformaticians and wet lab scientists
Experience managing molecular diagnostic assay / genetic test development and validation projects under design control and in compliance with CAP/CLIA and/or FDA regulations
Expertise as an alliance and/or collaboration manager is preferred
Knowledge of clinical diagnostics
Ability to map out components of a project and build estimated timeline for work using excellent communication and collaboration skills
Strong social skills and the ability to establish solid relationships and elicit agreement from a variety of stakeholders
Exceptional analytical and strategic problem-solving skills
Demonstrated ability to work both independently and collaboratively in a dynamic environment

All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.

Required profile