Do you want to make an impact as a Clinical Research Professional? Do you get energy from coordinating dynamic clinical trials with a quality-driven and pragmatic approach? Do you like to partner with many stakeholders? Do GCP ICH E6 R2 and ISO 14155 have no secrets anymore for you? You might be the Clinical Project Manager we are looking for!
What do we expect from you as a Clinical Project Manager?
The Clinical Project Manager is responsible for site and project management related to clinical trials, ensuring that milestones, timelines, budget and quality of such trials, as outlined by the study protocol, monitoring plan, SOPs, and applicable regulations and policies are met.
Main Responsibilities:
- Strategizes, oversees and coordinates successful execution clinical studies.
- Ensures that the rights and well-being of subjects are protected, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements.
- Is responsible for the overall documentation and adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s).
- Develops clinical study protocols and reviews/approves supporting documentation (such as monitoring plan, study plan, data management plan etc.)
- Develops patient recruitment and retention plans
- Establishes and cultivates a wide range of business relationships to facilitate completion of assignments
- Determines goals and objectives for projects
- Leads projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
- Develops and manages the study budget. Overall responsibility for negotiation of financial aspects of clinical studies / program.
- Uses discretion, diplomacy and tact to resolve difficult situations. Escalates serious issues to management.
- Participates in the development and coaching the study team.
Who are we looking for?
- You have a Bachelor or Master degree in biological or (para-) medical sciences
- Minimum of 7 years’ experience in clinical research or equivalent by education or relevant experience
- Minimum of 2 years’ experience as Clinical Project Leader and previous experience as a CRA is a plus
- You have a critical mindset, excellent communications and organizational skills.
- Ability to maintain composure in difficult circumstances
- Demonstrates ability to manage and oversee projects and related team activities
- A true QbD’er can be recognised by the following qualities:
- Resilient: Your strong and positive attitude helps you overcome any challenge
- Hungry for knowledge: You are always open to learning
- No BS mentality: you can be straightforward in a respectful way
- Innovative: You are constantly looking for new and better solutions
- (Not too) serious: your job is serious, but you don’t take yourself too serious.
What’s in it for you?
- QbD offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
- Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
- As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
- Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together
- Our promise to you:
- As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
- Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
- In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done!
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!