Clinical Project Manager
Il y a 2 mois
**Clinical Project Manager (CPM) - Antwerp, Belgium**
As a global Research Organization to the biopharmaceutical industry, **CellCarta** 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'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 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 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, PowerBI)
- 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
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