Lindsey Beirens Email & Phone Number

Bree, Be

Alken, Vlaanderen, België

Maastricht, Provincie Limburg, Nederland

• Oversees, designs, plans and develops clinical evaluation research studies.• Prepares and authors protocols and patient record forms.• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.• Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and preparesclinical trial budgets.• Responsible for clinical supply operations, site and vendor selection.• Builds and maitains optimal relationships and effective collaborations with various internal and external parties.• Uses cross-functional collaboration to strategize clinical decisions• Drives evidence dissemination & awareness.

Maastricht, Provincie Limburg, Nederland

• Oversees, designs, plans and develops clinical evaluation research studies.• Prepares and authors protocols and patient record forms.• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.• Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepareclinical trial budgets.• May be responsible for clinical supply operations, site and vendor selection.• Builds and maitains optimal relationships and effective collaborations with various internal and external parties.• Drives local evidence dissemination & awareness.

Brussels Area, Belgium

- Clinical study support including quality and compliance advice, study document review and site support- Streamlining protocol deviation handling on a global level, across trials and programs- Regulatory intelligence including implementation of updates in processes and procedures

Brussels Area, Belgium

• Provides project management expertise throughout the development and implementation of clinical studies. Interacts with various study support groups and the business unit in order to assist in clinical strategy, the development of study plans, and project deliverables.• Facilitates communication between R&D, Regulatory Affairs, Sales and Marketing, Training, Senior Management and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to mgmt staff. • Facilitates site selection process by conducting meetings with appropriate departments and individuals to review and revise draft site list as necessary, and by communicating the final site list to team members. • Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines. • Identify resource needs and elevates/resolves resource constraints with mgmt.• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. • Facilitates the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. • Provides input to protocol design, case report form design, data management plan, monitoring plan.• Organizes Steering Committee meetings and communication; Coordinates investigator and research coordinator meetings.• Oversees compliance to study requirements; Reviews compliance to protocol and elevates critical protocol deviations; Reviews monitoring reports.• Provides study-specific training to internal team members and site personnel.

Support a number of investigational sites to conduct company initiated clinical research in the cardiovascular field (Cardiac Therapies and Vascular Solutions).Ensure that the trial at the site level is conducted, recorded and reported in accordance with the clinical investigational plan, SOP’s and applicable regulatory requirements.

• Coordinate distribution of information related to incoming study requests to the approval committee members• Organize collection of documents and forms related to incoming requests and communicate with requestor to obtain the outstanding information/forms• Keep track of the work of KOL’s in interventional cardiology and endovascular interventions• Follow-up on approved projects regarding enrollment, budget, publication

• Preparation, processing, follow-up, and filing of research projects submitted to ISS Review Committee for review• Maintain and co-ordinates the ISS review process according to procedures and policies• Act as a pivotal point of contact for incomplete submissions and follow-up of the projects• Set-up and maintenance global web-based tracking tool for ISS, act as expert

• Keeping monitors, managers and customers updated about the status• Working together with internal and external partners to resolve issues• Clean patient data via vertical listings and manual review• Working together with Science team, statistics team, business aplication team, ... to build e-CRF’s, determine the needs for the corelab, …• Prepare the Clinical Events Committee• Providing training in the e-CRF system to GDT/ABT-employees and third parties• Writing of a Data Management Plan• Keeping records of data management issues, finding solutions and share with the involved people• Assist in the Protocol Deviation Committee• Make sure the various providers are working and integrating each others data • Discuss with other teams the needs for results, so the timelines can be set up• Franchises: Drug Eluting Stents, Bio-Absorbable Stents

• Reviewing Case Report Form data for clarity and inconsistencies via programmedchecks and listings• Generating, sending and processing of queries• Contacts with site managers (CRA's) and trial managers, Clinical team• Follow-up of the outstanding collection portions and DCF's• Validating edit checks• Experience in Phase 1 and Phase 2-3 trials• Franchises: Pain and Antipsychotics

• Maintaining the imaging material tracking database• Tracking all material (e-CRF's, imaging material, signatures, ...)• Keeping monitors, managers and customers (corelab) updated about the status• Working together with corelab to resolve issues• Opening, processing and closing queries in the e-CRF (working together withmonitors)• Make sure the data are clean, by vertical listings and e-CRF review• Working together with other teams to build e-CRF's, determine the needs for thecorelab, ...• Prepare all material for the Clinical Events Committee, and make sure they aredealing with it• Providing training in the e-CRF system to colleagues and third parties• Writing of a Data Management Plan, and implementing it• Keeping records of data management issues, finding solutions and share with theinvolved people• Assist in the Protocol Deviation Committee with data management tasks• Writing and tracking note to files• Make sure the various providers are working and integrating each others data(InForm, ICON, corelab, ...)• Discuss with other teams the needs for results, so the timelines can be set up• Franchises: Drug Eluting Stents, Bio-Absorbable Stents

• Reviewing Case Report Form data for clarity and inconsistencies via programmed checks and listings• Generating, sending and processing of queries• Contacts with site managers (CRA’s) and trial managers, Clinical team• Follow-up of the outstanding collection portions and DCF’s• Validating edit checks• Experience in Phase 1 and Phase 2-3 trials• Franchises: Pain and Antipsychotics

Master, Biomedical Sciences

Activities and Societies: Member Faculty Board Pharmacy Biomedical Sciences en Veterinary Sciences UA (2003-2004), Member Educational.

Ccir, Interventional Cardiology

Certified Cardiovascular Industry Representative http://www.judge.com/judgemed_cardiovascular.aspx

Bachelor, Biomedical Sciences

Activities and Societies: Member Educational Commission Biomedical Sciences tUL (2001 - 2002), Member Evaluation Committee Biomedical.