Clinical Project Manager
WHAT ARE YOUR MAIN RESPONSIBILITIES?
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.
- 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.
WHAT DO YOU HAVE TO OFFER?
- 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
WHAT DOES TRIUM, part of the QbD group, OFFER YOU?
We are a healthy company with a strong growth and international ambitions. In addition to an attractive salary package, we can offer you the following advantages:
- We've got your back, giving you the opportunity to shape your career.
- Thanks to our flat organization, we have short communication lines and you can always come to us.
- Standing still means going backwards. With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise.
- Get to know your colleagues outside the work environment! Teambuilding and fun activities are planned on a regular basis. A comedy night or quiz night? Nothing is too crazy for us!
- 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 (both in English) and who knows, we might welcome you soon in our QbD group!