Clinical Project Manager

HistoGeneX is a growing global research laboratory specializing in the field of immune-oncology. We strive to make a difference in the future treatment options offered to cancer patients.

We'd love to find a Clinical Project Manager to help us serve our sophisticated customers while adhering to our rigorous but sensible procedures.

As a HistoGeneX 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 HistoGeneX 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 HistoGeneX 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 HGX. His/Her responsibility starts when a clinical project is granted to HGX and finishes when the project is delivered to the sponsor, study properly archived and final invoicing prepared.

Additional responsibilities are:

  • 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 Master degree in Sciences, Biomedical Sciences, Pharmaceutical Sciences, Medical Biology, Medicine or similar expertise through experience.

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 that delicate balancing act of prioritizing multiple opportunities
  • Pro-level communication skills, proficient in English language, including writing and articulating your case
  • Proficient in Microsoft Office (Word, Excel, PowerPoint)
  • Excellent organizational skills and able to multi-task
  • Positive and energetic attitude
  • Able 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
  • Possesses 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
  • Operated 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.

Apply today and send your CV to: This email address is being protected from spambots. You need JavaScript enabled to view it.