Clinical Project Manager
Clinical Project Manager (CPM) – Naperville, IL, USA
As a global Research Organization to the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.
We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China, and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics, and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.
CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics, and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies, and diagnostics.
We would love to find 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
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.
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. Their responsibility starts when a clinical project is granted to CellCarta and finishes when the project is delivered to the sponsor, with the study properly archived and final invoicing prepared.
- 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
A Master's degree in Biology or Biochemistry, Biomedical Sciences, Pharmaceutical Sciences, Medicine.
Qualification and Skills
The Clinical Project Manager uses an arsenal of skills to successfully perform the required tasks.
On your first day, we'll expect 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
We offer an exciting and challenging full-time position in a multinational environment where customer focus and innovation are key business values. You will receive thorough on-the-job-training.
All applicants are considered for all positions without regard to race, religion, color, sex, gender, sexual orientation, pregnancy, age, national origin, ancestry, physical or mental disability, medical condition, military or veteran status, genetic information, marital status, ethnicity, citizenship or immigration status or any other protected classification, in accordance with applicable federal, state, and local news. By completing this application you are seeking to join a team of hardworking professionals dedicated to consistently delivering outstanding service to our customers and contributing to the financial success of the organization, its clients, and its employees. Equal access to programs, services, and employment is available to all qualified persons.