Clinical Project Manager
il y a 3 semaines
Clinical Project Manager
Summary
As a Project manager, you will 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.
As a CellCarta Clinical Project Manager (CPM), you will learn the entire business model and you will usually be the first to discover what our customers need.
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.
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.
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 are:
- Manage clinical studies from initiation, all the way through closeout 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
- 2+ years of project management, and/or CRA (clinical research associate) experience, or a history of working with histotechnology 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
- Prolevel communication skills, proficient in English language, including writing and articulating your case
- Proficient in Microsoft Office (Word, Excel, PowerPoint, PowerBI)
- Excellent organizational skills and able to multitask
- 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 stickwithit 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
- Genomic background, understanding the principles and knowledge about some techniques and platforms
- 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
- Experience working in global locations
What can we offer
- A dynamic and rapidly changing global environment allowing personal growth
- Training and personal development in a variety of (technical or people related) areas
- True career opportunities as the company grows fast
- A healthy work life balance with onsite and remote working
- A company that is fit for the future
- A competitive salary and benefits
- A great team you can work with
About CellCarta
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry.
Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials.
The company operates globally with over 1000 employees in its 11 facilities located in Canada, USA, Belgium, Australia, and China.
**Join-
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