Clinical Project Associate

AbbVie is seeking a motivated Clinical Project Associate to join our Real World Evidence team in Belgium. In this role, you will manage non-interventional clinical studies across Belgium and Luxembourg, ensuring compliance with approved protocols, procedures, and regulations. 

For your assigned non-interventional studies, you will closely collaborate with the medical affairs team and other functions, to make sure that the study specific milestones are met including but not limited to: site selection, site feasibility, study start-up including Ethics Committee (EC) submission, study follow-up and study close-out.

In this role, you will partner with numerous stakeholders inside and outside the affiliate and build expertise across several core business functions.

The function will be based in Belgium and will report to the Affiliate Real World Evidence Lead (ARWEL).

Tasks & Responsibilities

1. Pre-study activities

• Support the Clinical Project Manager (CPM) in developing the study plan, outlining tasks, timelines, resource allocation needed for study initiation, training and study-specific procedures
• Collaborate with CPM, Medical Managers (MM), Medical Advisors (MA), Medical Science Liaisons (MSL) for an effective site selection process
• In case of Global studies, be the point of contact for Global Medical Affairs (GMA) for the assigned clinical studies
• For Affiliate studies, assist the RWE Manager and CPM in Clinical Research Form (CRF) development
• Ensure that all pre-study activities are performed in a timely manner

2. Study start-up activities

• Prepare, collect, file, maintain and archive all all essential study documents
• Conduct budget negotiation with investigational sites
• Coordinate legal discussion on Clinical Study Agreements (CSA) with the respective legal departments 
• Ensure timely signature of CSA
• Prepare protocol synopsis and ensure translations in local languages
• Prepare study-specific Informed Consent Forms (ICF) using the country specific (NL & FR) ICF template
• Prepare and manage clinical study submissions to ECs
• Follow-up on EC approval within the required timelines
• In compliance with the applicable AbbVie Standard Operating Procedures (SOP) develop required study-related documents (e.g. site selection plan, monitoring plan,…)
• Ensure initiation visits are performed according to required timelines

3. Study maintenance activities

• Ensure on-site visits (if needed) and close-out visits are performed according to the monitoring plan
• Ensure proactive follow-up on study progress/issues and if necessary, develop and implement strategic/corrective action plans
• Assist sites with study-related issues and questions
• Ensure final study report is sent to investigators/ECs within the required timelines
• Act as the main line of communication between AbbVie and the investigators/site staff and coordinate distribution of study-related communications to all sites (e.g. newsletters, mailings, etc)
• Ensure relevant internal communication with the affiliate medical affairs teams involved in the study
• Update central (TESLA, Sharepoint,…) and relevant local tracking systems within the required timelines
• Report site/study status to the CPM/ARWEL and to the GMA study team on a regular basis
• Participate in GMA-driven study teams calls
• Ensure execution of payments to Investigational sites as defined in the CSA
• Ensure study-related budget tracking and report to ARWEL/Finance team as requested

4. Other activities

• Participate in preparatory activities required for regulatory and QA audits, and assist in formulation of responses to observations pertaining to areas of responsibility
• Manage translation for appropriate study documents
• Attend timely relevant internal and external trainings, complete documentation or provide written evidence of attendance