Sr. Clinical Project Manager

Il y a 7 mois

Wilrijk, Belgique CellCarta Temps plein

**Sr. Clinical Project Manager**

**Summary**

As a Sr. 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 Sr. Clinical Project Manager (CPM), you will learn the entire business model and you will usually be the first to discover what our customers need. As a CellCarta SR. 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.

**Responsibilities**

The Sr. 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 Sr. 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**:

- Lead a team through effective coaching and mentoring, fostering a culture of continuous learning and growth, while proactively engaging and aligning stakeholders to organizational objectives
- Assume responsibility for overseeing high-profile projects, meticulously managing timelines and resources to ensure timely delivery. Develop and communicate a long-term vision, conducting regular risk assessments to anticipate and mitigate potential obstacles.
- Drive efficiency and productivity by optimizing operational frameworks and streamlining processes. Conduct thorough assessments to identify and eliminate waste, continually seeking opportunities for improvement and innovation.
- 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**
- 6+ 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 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
- 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 healt

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