Senior Clinical Project Manager

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? Do you want to be surrounded by fantastic colleagues in an authentic and growing company and be one of our ambassadors? You might be the Clinical Project Manager we are looking for at QbD Clinical!

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, that the reported study data are accurate, complete, and verifiable from source documents, 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).
• Oversees quality of data collection, management of study supplies and resources in adherence with the project timelines, budget and quality standards
• Oversees start-up, enrollment, follow up and closure of clinical trial activities
• 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
• Reports and presents to core teams and upper management
• Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments
• Interacts with and manages vendors and stakeholders, as required
• 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.
• Represents the organization as a prime contact on contracts or projects. Develops and manages the study budget. Overall responsibility for negotiation of financial aspects of clinical studies / program.
• Interacts with senior internal management and external personnel on significant matters often requiring coordination between involved team members and stakeholders.
• 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?

• Master degree in biological or (para-) medical sciences or equivalent by experience
• 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
• Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook)
• Excellent oral and written communications skills
• Excellent interpersonal skills
• Team player
• Inspirational and motivational skills
• Demonstrates ability to manage and oversee projects and related team activities
• Demonstrates ability to make timely and well-reasoned decisions
• Demonstrates ability to effectively and persuasively communicate verbally and in writing
• Demonstrates ability to identify and adapt to shifting priorities and competing demands
• Ability to maintain composure in difficult circumstances
• Sensitive to cultural differences
• Fluent in Dutch, French and English. Other languages are a plus

A true QbD’er can be recognized 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 non-sense mentality: you can be straightforward in a respectful way
• Innovative: You are constantly looking for new and