Lucian Balan

Head of the UK Clinical Operations

PSI CRO AG

Jan 2023 - Current (3 years 8 months)

Associate Director Clinical Operations

Syneos Health

Apr 2019 - Oct 2022 (3 years 7 months)

Global support for one of the clients (overseeing 30+ managers' compliance, recruitment, CRAs’ KPIs on 500+ global studies, directly responsible for client invoicing). Provide training and onboarding for new line managers Direct communication with the client for the assigned responsibilities Prepare monthly governance and ad-hoc reports for the client and senior management (Sr. Dir/VP) related to project health status and KPIs Provide and develop solutions to improve the KPIs and processes for the entire FSP and Strategic Accounts department Until Mar 2020 managed 2 clients in the UK – up to 16 individuals (Sr CRAs, Sr CTAs, PMs)

Senior Regional Clinical Monitoring Manager, Strategic Resourcing

Syneos Health

Oct 2017 - Mar 2019 (1 year 6 months)

Manage customer's dedicated clinical monitoring teams located in Western Europe (4 countries). Fully responsible for selecting and onboarding new staff, supervising, the quality of assigned staff's clinical work, appraising performance and guiding professional development. Manage direct relationships with sponsors for assigned countries Responsible for financial review and forecast for assigned countries Streamline and standardize processes within the department

Regional Clinical Monitoring Manager, Strategic Resourcing

Syneos Health

Sep 2014 - Sep 2017 (3 years 1 month)

Manage a customer dedicated clinical monitoring team located in Western Europe (11 countries). Fully responsible for selecting and onboarding new staff, supervising, the quality of assigned staff's clinical work, appraising performance and guiding professional development. Manage direct relationships with sponsors for assigned countries Responsible for financial review and forecast for assigned countries

Manager, Clinical Site Monitoring Solutions

IQVIA

Aug 2013 - Apr 2014 (9 months)

Manage the European team of Clinical Solutions Specialists (CSS). One of the main CSSs tasks is to combine clinical and financial data from various sources and present it into various reports, to make more efficient the work of CRAs, CTLs, PMs or upper management. Collaborate continuously with studies' PMs and team lead to make sure that reports meet or exceed their expectations in terms of quality, delivery, and ease of use. Actively participate in initiatives to improve the company’s processes Regular review of the team assigned studies for budget recognition, resources, quality and timely delivery

Manager, Project Coordination Center

IQVIA

Aug 2012 - Jul 2013 (1 year)

Manage a team of remote monitoring staff in the UK, and South Africa and a team of Technical Solution Specialists in France, Netherlands, Poland, Germany, and Serbia. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Participate in the selection and onboarding process for new staff by conducting candidate reviews and participating in the interviewing process. Manage the quality of assigned staff's clinical work through regular review and evaluation of work product. Identify quality risks and issues and create appropriate corrective action plans to prevent or correct d

Clinical Operations Manager, Flexible Resourcing

IQVIA

Jul 2010 - Jul 2012 (2 years 1 month)

Perform all assignments listed as Clinical Operations Manager within a team of customer dedicated staff (outsourced) Manage directly relationship with the sponsor

Clinical Operations Manager

IQVIA

Apr 2009 - Jun 2010 (1 year 3 months)

Perform all assignments as Assoc. Clinical Operations Manager and: - Manage the human, material, system and budget resources to provide clinical monitoring services within a designated office - Ensure that clinical staff (CTAs, CRAs and CTLs) gain the necessary skills to perform their respective job responsibilities - Participate in clinical operations quality or process initiatives

Associate Clinical Operations Manager

IQVIA

Oct 2007 - Apr 2009 (1 year 7 months)

- Manage a team of CTAs/CRAs/CTLs including planning, assigning and directing work - Appraising performance and guiding professional development - Rewarding and disciplining employees, addressing employee relations issues and resolving problems - Participate in the selection and onboarding process for new staff by conducting candidate reviews and participating in the interviewing process - Manage the quality of assigned staff’s clinical work - Provide oversight for the execution of the training plan - Participate in the allocation of resources to clinical research projects - Identifies quality risks and issues and creates appropriate corrective action plans

Senior Clinical Research Associate

IQVIA

Jul 2007 - Sep 2007 (3 months)

- Clinical monitoring of assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas from start-up phase to close-out by the contracted scope of work and ICH-GCP - Act as a mentor for clinical staff including conducting co-monitoring and training visits.

Clinical Research Associate

IQVIA

Feb 2004 - Jun 2007 (3 years 5 months)

- Clinical monitoring of international clinical trials (phase II, III, IV) from project start-up phase to close-out by the contracted scope of work, SOPs and ICH-GCP - Feasibilities - Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form completion and submission, and data query generation and resolution

R

Medical Editor

Romanian Angel Appeal

Jan 2003 - Jan 2004 (1 year 1 month)

- search and identify medical articles relevant for organization’s website - contribute to e-learning content and portal - monitor assistant - translate from/in English medical articles

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