Junior Project Manager - Clinical Development
Junior Project Manager - Clinical Development
08/10/24
Location
Zoersel, Belgium
Vacancy
2 Bridge company
2 Bridge is a Belgian-based company that provides advice and support on all key disciplines of healthcare product development (discovery, pre-clinical, clinical and product development, registration and life-cycle management). We work globally with startups, biotech, pharma, and investors.
2 Bridge typically operates via flexible and cross-functional teams, aligned to the project need. Our broad and multidisciplinary expertise allows to address the most complex and challenging tasks during development. For more information, please visit: www.2Bridge.be.
Job description
We are looking for a junior Project Manager Clinical Development with a keen interest to learn about setting up and managing clinical studies.
You will be involved in managing the planning and execution of operational activities related to the start-up, conduct and closure of a clinical study with internal and external partners, according to established timelines and budget, with support and under the guidance of a senior Clinical Development professional.
Key activities of a junior project manager Clinical Development are support in:
Managing a cross-functional clinical study team;
Set-up and roll-out of a feasibility exercise prior to the start-up of a clinical study;
Selection and management of external service providers (clinical research organization, central lab, interactive web response system, …);
Set-up and follow-up of study timelines and budget;
Preparation and review of essential clinical documents (e.g. protocol, informed consent form, case report form, study plans, ….);
Oversight on submissions to Competent Authorities and Ethics Committees/Independent Review Boards etc.;
Follow-up on subject recruitment and contingency planning;
Oversight of site management and monitoring activities, including co-monitoring, if required;
Follow-up on data collection and cleaning during the study until database lock;
Ensuring appropriate filing and archiving of study documents;
Contributing to the development of a clinical study report;
Ensure compliance with applicable regulations and guidelines, in particular ICH-GCP;
Develop / improve of clinical procedural documents and processes.
What we offer
Be part of a multidisciplinary team that values versatility, adaptability, and effective cross-functional collaboration, in the spirit of our values: ‘we care, we adapt, we drive to excel’. By being exposed to a multitude of projects and functions, you will quickly gain a broader view of drug development, thereby enhancing your professional growth.
You will work in a non-hierarchical environment that highly values teamwork and where you will have the freedom to shape your role. We believe in fostering a culture of learning and continuous feedback, where everyone feels supported and empowered to succeed.
We build a safe work environment where people feel comfortable speaking up, taking accountability, and balancing their personal boundaries with business expectations. Our team collaborates and supports each other, creating a dynamic and inclusive workplace where you can thrive.
Qualifications/Desired profile
MSc in Pharmacy, Chemistry, Bio-engineering, Bio-Medical sciences or equivalent;
Some experience in clinical research and/or clinical research organization; although industry-starters with the right mind-set and interest in clinical development will also be considered.
Enthusiasm with a keen interest to learn new things
Team-player with the ability to work in a multidisciplinary team and independently;
Strong organizational and communication skills;
Analytical, pro-active, problem solving, flexible;
Enthusiasm with a keen interest to learn new things;
Fluency in English is a must
How to apply
CV, motivation letter where you:
Introduce yourself
Explain why you are interested in the job
Outline why you think you are the right candidate
Interested? Please send your motivation letter and CV to HR@2bridge.be.