Joyce Meulemans Email & Phone Number

Leuven, Flanders, Be

Mechelen

Support the Development team in contributing to the clinical evaluation of new drug candidates through the operational management of multinational clinical studies from phase I till III.In particular:• Responsible to deliver a clinical study from initial planning, setup and study conduct until final reporting phase within agreed budget, timelines and with high quality (comply with GLPG processes).• Initiate and coordinate the vendor selection process through RFI, RFP & BID meetings• Be the primary contact person for selected ESP and ensure high quality oversight according to study plans, timelines & budget •Coordinate study document creation (Clinical Study Protocol, DSMB charter, Informed Consent Form, Clinical Study Report,…)• Review and/or approve study documents (Monitoring Plan, TMF plan, Data Management Plan, Safety Plan, eCRF, SAP, Mock TLFs, DTA/DTS a.o.)• Ensure proper filing and archiving of TMF• Internal single point of contact for assigned clinical studies, close interaction with functional experts involved in the clinical study (Medical Monitor, PK/PD lead DM, Stat, CMC,…).• Organize Study Meetings with ESP & ad hoc internal functions• Act as Clinical Study representative in Clinical Working Groups• Organize and lead the Investigator Meetings• Interact with the Quality Monitor and follow-up on audit reports & CAPA set-up• Actively initiate and participate in Process Improvement initiatives

Mont-Saint-Guibert

As Clinical Manager I was responsible for global study management. My main responsibilities were, but not limited to:1. Global day to-day Management of the clinical trials • Plan, establish and guard study time-lines, required resources and protocol specific milestones• Responsible for the set-up and maintenance of the administrative structure of the project(s)2. Coordinate with the project team:• Preparation of the materials for clinical trials (Investigational plan, Investigators brochure, Patient information, monitoring and study guidelines ...)• Preparation of files for the submission to Ethics committees, Competent Authorities and other bodies if needed• Preparation of files for Clinical trial insurance• Follow-up of agreements with hospitals and investigators in collaboration with Contracts & Payments team3. Coordinate eCRF development together with Data Management vendor and/or CRO4. Coordinate of payments to clinical sites according to contract milestones in collaboration with Contracts & Payments team5. Develop and manage Clinical study budget6. Follow-up of enrolment and milestone follow-ups and develop actions to optimize it (metrics, KPI, etc)7. Writing Project plan and study plans8. Ensure proper clinical trial monitoring, escalation and mitigation9. Ensure Regular communication with the study sites and CROs10. Management of CRO and vendors11. Ensure set-up and coordination of study committees12. Oversee Study documentation (TMF)13. Clinical Study Report: lead CSR delivery process and contributors14. Regular reporting of project status

Waver

As Sr. CRA I was the central point of communication between the sponsor and the investigators for all clinical trial related activities to assure trials were conducted on time and budget, while fully GCP, ICH and SOP compliant. The activities were across multiple phases and multiple therapeutic areas.My responsibilities were, but not limited to:• Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial• Assume ambassadorial role to facilitate communication between sites and key client line functions to increase value proposition to investigators• Facilitate preparation and collection of site level documents• Execute site initiation and training activities• Perform both on-site and remote monitoring visits according to monitoring plan• Manage drug supply at site level• Resolve site level update of technical systems (Clin Admin, EDC)• Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc)• Manage recruitment implementing appropriate contingency plans as needed• Assure continual CP, ICH and SOP compliance (informed consent process, source data verification, AE and SAE reporting, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training• Author study monitoring reports• Perform data query resolution process (both at site and with data management)• Execute site closeout activities• Train junior CRAs

Mont-Saint-Guibert

I was responsible for the close-out activities of a clinical trial. I managed all the close-out activities for this clinical trial and performed multiple close-out visit at all participating sites.

Brussels

As Sr. CRA I was the central point of communication between the sponsor and the investigators for all clinical trial related activities to assure trials were conducted on time and budget, while fully GCP, ICH and SOP compliant. The activities were across multiple phases and multiple therapeutic areas.My responsibilities were, but not limited to:• Participate in site nomination process; perform evaluation of site capability and make recommendation for inclusion in clinical trial• Assume ambassadorial role to facilitate communication between sites and key client line functions to increase value proposition to investigators• Facilitate preparation and collection of site level documents• Execute site initiation and training activities• Perform both on-site and remote monitoring visits according to monitoring plan• Manage drug supply at site level• Resolve site level update of technical systems (Clin Admin, EDC)• Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc)• Manage recruitment implementing appropriate contingency plans as needed• Assure continual CP, ICH and SOP compliance (informed consent process, source data verification, AE and SAE reporting, protocol, drug accountability etc.). Resolve deviations to standard by remedial action and training• Author study monitoring reports• Perform data query resolution process (both at site and with data management)• Execute site closeout activities• Train junior CRAs

I was responsible for the organization of trainings for the investigators that were part of the network at CTN.I collaborated with external experts and trainers to develop the most customized trainings. This was an additional function to my CRA position.

As CRA I was responsible for site management, and compliance of assigned clinical projects at all phase of the development. I was involved in the primary contact with medical professionals at site. I worked closely with the Clinical Project managers of the trials as well as senior management. As a CRA I had to ensure that all activities were conducted in accordance with government regulations, Good Clinical Practices (GCP) and Standard Operations Procedures (SOPs).My responsibilities were, but not limited to:• Manage / Contribute to the study site selection process by preparing feasibility questionnaires and conducting site interviews.• Organize investigator’s start-up meeting and study site initiation meetings.• Develop various study specific forms/templates and prepare/manage study status reports.• Assist in vendor set-up, and oversight of vendors.• Review essential documents from study sites for accuracy and completion. Conduct set-up ofTMF and review for reconciliation of required documentation.• I was the first point of contact for the site staff.• Conduct monitoring visits and co-monitoring visits: coordinate with clinical investigators in thetimely completion, submission, and review of CRFs and verify report data against protocol andpatient files.• Provide support to clinical investigators and study coordinators to resolve site-related issues• Communicate all relevant and critical issues to management.• Assure compliance for assigned projects with clinical research policies and procedures.• Manage progress by tracking regulatory submissions, recruitment, case report form (CRF)completion, and data query resolution.• Contribute to the review of all SAEs, site notification and compliance with all company procedures.• Manage clinical aspects of database lock by participating in data listing review.• Provide guidance to product supply process and oversee site shipments

Brussels Area, Belgium

I managed the day-to-day patient care, by visiting the patients in their familiar environment at home. Providing support to the patient in developing their personal care. Supporting the family was also a part of my job. During this job, I learned to develop my nursing skills, organizational skills, social skills and collaborating with other professionals. I learned to work independent and working with a remote team. Delivering quality for the total care of the patient was a must. The patients need at different levels was what drove me the most.

Bachelor Verpleegkunde, Ziekenhuisverpleegkunde

Graduaat Pedagogisch Begeleider, Specifieke Lerarenopleiding

Economie-Moderne Talen

Safety Officer Grade 3

Clinical Project Manager, Clinical Project Management

Prince2 Foundation

Project Management

Ich-Gcp Clinical Practice Refresher & Addendum 2016

Cro Management

Ich-Gcp E6 (R2) Addendum 2016