ALTEN Belgium is a leading consultancy company in the fields of Life Sciences, Engineering and IT in which our people and clients are central.
In our open and adaptable organization, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.
All employees together form a large network of expertise, even at an international level. In this way we offer optimal growth to our consultants and the best solutions for our customers.
We are currently looking for a Senior Clinical Research Associate (Sr. CRA) to join our Life Sciences team in Belgium. This individual will be responsible for managing clinical activities at study sites conducting studies for the MedTech group, as well as, fostering strong, productive relationships with colleagues within the MedTech Group. Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between the clinical study team and study site personnel for the specific clinical projects.
Clinical Study Site Management 95%
Other Administrative Activities 5%
Key Job Activities:
Clinical Study Site Management Tasks
• Ensures that all work related activities, and decisions embody the Credo Values.
• Verify safety and well-being of study subjects are maintained for assigned study sites.
• Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
• Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.
• Accountable for study site performance, and providing high quality data according to overall project timeline.
• Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.
• Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
• Responsible for supporting patient recruitment and retention activities.
• Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
• Assists with internal communication of important clinical data and events.
• Support organization of Investigator and other study training meetings, if required.
• Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
• Understand business value of clinical projects and balances overall business objectives and functional needs.
• May be involved in other tasks to support Clinical Operations and Operating Company as needed.
• Support the implementation of new clinical systems/processes.
• Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.
Administrative Tasks
• Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• May be asked to provide additional support to Clinical Operations staff, as needed.
Education
• A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
Experience
• Typically requires Bachelor's degree with at least 4 years of relevant experience; Masters or PhD/MD/PharmD with at least 2 year of relevant experience.
• Previous clinical research experience required.
• Previous medical device monitoring or equivalent experience required.
• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background – a plus.
Knowledge
• Requires experience and knowledge working with computer systems(Microsoft Office – Excel, Word, and Power Point).
Additional Requirements
• Demonstrated competencies in the following areas are required:
o Leadership
o Written and verbal communications
o Presentation and influencing
o Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines).
o Ability to travel up to 80% of time.
What ALTEN has to offer
* A permanent contract;
* A salary package in line with your experience and extra benefits (company car, meal vouchers, recovery days, insurances);
* The possibility to join a great team and be part of the success story of an international group.
We are also open to work with freelancers!
Apply now and be a part of our amazing journey. We believe in growing together!
We are looking forward to getting to know you and your ambitions!