Clinical Project Associate

AbbVie is seeking a motivated Clinical Project Associate to join our Real World Evidence team 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

Qualifications :

• Degree in Science Engineering or Medical field
• Approximately 3 years of experience in industry-based pharmaceutical clinical research   
• Knowledge of the drug development process
• Understanding of the healthcare environment within the pharmaceutical industry
• Good knowledge of the clinical trial legislation in Belgium and ICH/GCP requirements
• Very good knowledge of Dutch and/or French as well as English (spoken and written)
• Good oral communication skills and strong persuasive abilities
• Familiar with standard IT office tools
• Full driving license
• Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity
• Dynamic strong planning and organizational skills and the ability to deliver results
• Ability to lead in matrix organizations: Collaborative team-oriented approach able to build develop and support relationships across the affiliate
• Ability to work independently and in a team-oriented environment

Additional Information :

Competencies Ways we Work at AbbVie

• All4OneAbbVie - Interpersonal Savvy: Relates well to all kinds of people up down and sideways inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably
• Decide Smart&Sure - Dealing With Ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isnt upset when things are up in the air; doesnt have to finish things before moving on; can comfortably handle risk and uncertainty
• Agile&Accountable - Managing Vision and Purpose: Communicates a compelling and inspiring vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision shareable by everyone; can inspire and motivate entire units or organizations
• Clear&Courageous - Managerial Courage: Doesnt hold back anything that needs to be said; provides current direct complete and actionable positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation (not including direct reports) quickly and directly; is not afraid to take negative action when necessary
• Make Possibilities Real Planning: Accurately scopes out length and difficulty of tasks and projects; sets objectives and goals; breaks down work into the process steps; develops schedules and task/people assignments; anticipates and adjusts for problems and roadblocks; measures performance against goals; evaluates results

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time