Clinical Project Manager

Clinical Project Manager (CPM) – Naperville, IL, USA

Are you ready to launch your career in the exciting world of clinical trials and biotech? We're seeking a driven and detail-oriented Clinical Project Manager to join our dynamic team. This entry-level role offers the opportunity to gain hands-on experience and grow your expertise in a fast-paced, innovative environment. As a key member of our team, you will have the opportunity to work with cutting-edge technology, collaborate with cross-functional teams, and gain valuable experience in project management. Get ready to take your first step in a rewarding career in the biotech industry and join us today!

Summary

We're looking for a Clinical Project Manager to help us serve our sophisticated customers while adhering to our rigorous but sensible procedures.

As a CellCarta Clinical Project Manager (CPM) you learn the entire business model and you will usually be the first to discover what our customers need. As a CellCarta CPM, you’re ultimately responsible for embodying 3T’s.   Always keep the project on Task, on Track and on Time.

You will need to be comfortable doing the following:

• Listen well to the customer and build relationships to establish client satisfaction
• Manage yourself well under pressure
• Prioritize being effective over being right
• Be willing to transform yourself

If you are organized, analytically minded, possess a solid technical background and will thrive in our dynamic, high complexity environment, this might just be the role you are looking for.

Purpose of the function

To drive and manage projects with internal stakeholders and external customers (pharma and biotech partners in oncology) in order to deliver results on time in full and in agreement with the CellCarta Quality System. CPMs have project management skills and are able to hold scientific discussions with the sponsor in relation to the project. CPMs are part of the Clinical Operation group.

Responsibilities

The CPM is responsible for the delivery of clinical projects within the agreed scope, time and budget, primarily by coordinating a multitude of tasks performed by internal and external partners. The CPM ensures that the project is accomplished within the quality system of CellCarta. His/Her responsibility starts when a clinical project is granted to CellCarta and finishes when the project is delivered to the sponsor, study properly archived and final invoicing prepared.

Additional responsibilities

• Manage clinical studies from initiation, all the way through close-out and archiving, including reporting, in compliance with GCP guidelines and regulations. 
• Review of all required essential documents necessary for study initiation and ensure audit ready study files throughout the duration of the study
• Prepare and/or approve design sample flows; study trackers; Bio-Analytical Report; and other required documents for clinical studies
• Study budget control
• Maintain and document professional communication with the sponsor; cross functional project team and management throughout the duration of the study
• Chairing sponsor calls
•  

Required education

A Masters degree in Biology or Biochemistry, Biomedical Sciences, Pharmaceutical Sciences, Medicine or a Bachelors degree with experience.

Qualification and Skills

The Clinical Project Manager uses an arsenal of skills to successfully perform the required tasks. 

On your first day, it will be beneficial for you to have:

• 2+ years of project management, and/or CRA (clinical research associate) experience, or a history of working with histo-technology laboratories
• A great curiosity and a learning appetite that is layered on top of a humble and teachable spirit
• Prior success managing complex projects to completion with rave reviews, and can pull off the delicate balancing act of prioritizing multiple opportunities
• Pro-level communication skills, proficient in English language, including writing and articulating your case
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Excellent organizational skills and multi-tasking
• Positive and energetic attitude
• Ability to take initiative, be adaptable, and strive in a dynamic environment
• Diligence and strong attention to detail
• Ability to work independently and as a team member
• Critical thinking and problem solving skills
• Customer and Project Manager service oriented
• A solution mindset and an unrelenting stick-with-it outlook

It's great, but not required, if you have

• Experience in cancer research, understanding of the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and the scientific, statistical, regulatory, and compliance requirements of clinical research
• Experience operating in CAP, CLIA, GCP environments and have a working knowledge of EMEA and/or FDA guidelines related to clinical trials
• Programming and validation of data experience
• Worked in global locations

Benefits

CellCarta is made up of dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world! 

We offer a wide range of benefits including: 

• Competitive wages
• Medical, dental, and vision benefits 
• 401k retirement savings plan with a healthy match 
• Vacation and sick time 
• Career development opportunities 
• Continuing education 

About Us  

CellCarta is a rapidly growing, stable company. We are a leading provider of pre-clinical and clinical trial services to pharmaceutical and biotechnology companies. Our laboratory service offerings include immunohistochemistry, FISH, CTC isolation and characterization, chemosensitivity testing, tissue procurement, flow cytometry, ELISA, mutation testing, cell expansion, and colony-forming assays. CellCarta is a CLIA-licensed and CAP-accredited laboratory, and we perform studies in compliance with the relevant portions of Good Laboratory and Good Clinical Practices. 

Join us as we make an impact on the future of patient therapy! 

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