Biljana Bijelić

Site Activation Lead

ICON Clinical Research

Sep 2021 - Current (4 years 10 months)

Lead clinical trial start-up activities by understanding the clients' objectives and assist them in the development of the plan for country and site distribution. Prepare and contribute to client and project specific site activation strategy and site activation plan and work cross-functionally to ensure that the sites and countries chosen optimize opportunities for successful delivery of the project. Knowledgeable in the areas of clinical trial operations, meeting regulatory and ICON guidelines, and displaying project management skills to optimize performance and collaboration to ensure successful study outcomes. Study Start up experience leading sponsor initiatives such as kick-off meetings, bid defenses, project update and status calls, a

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RSM and Regulatory and Start Up Specialist II(South East Europe)

Allergan Abbvie

Sep 2017 - Sep 2021 (4 years 1 month)

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RBM / Reg Aff. Specialist

Allergan Abbvie

Jun 2017 - Sep 2021 (4 years 4 months)

Responsible for monitoring all types of clinical trials; assuring adherence to Good Clinical Practices and all other applicable laws and regulations, investigator integrity, and compliance with all study procedures, management of clinical trials. Primary responsibility site management and performance (including documentation) according to ICH guidelines (and country specific guidelines and government regulations), as well as FDA regulations (state and local laws), GCPs, and SOPs. Site management activities included all in house and on-site monitoring for all visit types. Collaboration with the Project managers and Line Manager to provide input into clinical management of a clinical study. Data quality assurance: In-depth review of subject-l

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Regulatory and Start Up Specialist II / Site ID, Feasibility, Capability

Quintiles IMSIQVIA

Jun 2015 - Sep 2017 (2 years 4 months)

Acting as a key point of contact with the sponsor and internal team regarding all Regulatory activities for the assigned study. Overseeing all associates assigned to work on the regulatory, ethics and essential document portion of the study. Assuming responsibility on deliverables at the project level. The planning, coordination and oversight of all processes involved in gaining approvals required in each country for a clinical trial to commence. This will include competent authority approvals, ethics committee approvals, import license approvals, radiation approval, tissue/biological sample export and any other local approvals required in a given country. Experienced clinical research professional to specialize in clinical trial intelligen

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Clinical Trial Manager

QuintilesGFR department(Sponsor dedicated)

Jun 2013 - Jun 2015 (2 years 1 month)

Monitoring of the clinical trial and conducting source data verification of the case record forms using paper based and/or EDC Systems in accordance with the protocol and trial specific monitoring/trial product reference manuals. Conducting Site ID and study start up meetings and study, center closure center closure. Organizing and maintenance of the Investigator Files, Trial and Site Master files. Training trial staff or other monitors on trial related procedures, EDC or SOP's.

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Senior Clinical Trial Coordinator Submissions – Regulatory

OptumInsight

May 2010 - Jun 2013 (3 years 2 months)

Monitoring of the clinical trial and conducting source data verification of the case record forms using paper based and/or EDC Systems in accordance with the protocol and trial specific monitoring/trial product reference manuals. Conducting Site ID and study start up meetings and study, center closure center closure. Organizing and maintenance of the Investigator Files, Trial and Site Master files. Training trial staff or other monitors on trial related procedures, EDC or SOP's.

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SMA/ Country Expert

OptumInsight

May 2008 - Dec 2010 (2 years 8 months)

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Main Pharmacist

PRIMA pharmacy

May 2000 - May 2008 (8 years 1 month)

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