Senior Project Manager Clinical Trials
Senior Project Manager Clinical Trials
08/07/21
Location
Het Hofveld 6F, GROOT-BIJGAARDEN, Belgium
Vacancy
We aim to enhance access to medical treatment
by delivering excellence in the design and execution of clinical trials.
YOU ARE
…passionate about clinical research and aspire to play a crucial role in bringing new medical treatments to market?
...looking for an entrepreneurial fast-growing company specialised in supporting interventional clinical trials where taking ownership and collaboration are key values?
Then check out this great opportunity to join us as a
SENIOR PROJECT MANAGER
Who are we
DICE is a clinical research organization (CRO), that carries out all biometrics aspects of clinical research for pharmaceutical and biotechnology companies, from data management to processing statistical analysis and clinical study report compilation. DICE provides (electronic) data capture, data management, statistics, PK analysis, central imaging reviews, medical monitoring and medical writing services. Check us out on: www.dice-cro.com.
What makes DICE unique
We offer an entrepreneurial environment where you get to partner with start-ups as well as well-established companies. You will be instrumental in their success to bring new medicines to market safeguarding the correct process both from an ethical as statistical point of view;
You will be working on a variety of projects and contribute to different aspects ranging from design to final delivery;
We are committed to your continuous learning and development;
Collaboration and team spirit define our culture and strong values like service, excellence, integrity and ownership – ensure we deliver superior results for our customers.
What will you be doing
As a Senior Project Manager, you will manage a cross-functional team in the execution of the biometrics and medical affairs (medical review, central imaging and pharmacovigilance) aspects of a clinical trial. Your main responsibility is to plan, organize, coordinate and control the project-related biometrics activities in order to achieve all the objectives described in the contract within the constraints of timelines and budget and while keeping compliance with ICH-GCP and the applicable procedures.
You will:
Serve as the biometrics primary contact to the sponsor and other parties involved in a clinical trial
Assist in the initial budget and negotiations with the sponsor
Coordinate the assignment of a project team
Create and manage timelines for project delivery and distribute to internal and external parties
Follow up together with the project team on the status of the project towards the defined deliverables
Be responsible for regular project budget review
Actively review any changes to the scope of the project and discuss changes with the customer
Manage project audits with the QA manager
Ideal work experience and education
A University degree or PhD in (Life) Sciences or equivalent through experience in another CRO
Minimum 5 years of experience with biometrics project management in clinical trials
Strong knowledge and working experience with ICH-GCP guidelines & procedures, DIA Reference model
Excellent knowledge of MS Office
Good communication and negotiation skills
Good verbal and written skills in English - knowledge of Dutch or French is a plus
What makes you stand out
Strong connector who inspires and motivates
Excellent stakeholder management skills combined with right influencing approach
Focus with an eye for detail and a passion for quality
Achievement orientation and high energy
Entrepreneurial mindset with a customer obsession
Can do attitude and the flexibility to engage in a variety of tasks
Growth mindset to continuously learn and stay on top of latest developments
The ability to work autonomously, as well as collaboratively in a team, in an atmosphere where giving constructive feedback is a must
What we offer
A competitive package with extra-legal benefits (company car, mobile phone, meal vouchers, and insurances package).
A young and dynamic work environment
A strong commitment to your professional growth and continuous development
An easy to reach office & possibilities to work from home
We promote flexibility in working arrangements.
Your success will be the result of your entrepreneurial drive, passion for delivering superior results and your desire to fulfil the commitments to clients and co-workers.
Take your career to the next level, and apply now
Check us out on: https://www.dice-cro.com/
Send your applications to: elke.willaert@dice-cro.com