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.

Job application