1. Clinical Project Manager (CPM) responsible to manage, control and co-ordinate along with project team(s)/member(s) performing of clinical trial project life-cycle (initiate, plan, conduct, close). Experience in different clinical trial phases (I-IV) and therapeutic indications.
2. 10+ years experience in pharmaceutical industry (primary clinical research and development).
3. Postgraduate academic specialization degree in pharmaceutical management & marketing.
4. Valid work permit to work in EU/Swiss. Dual citizenship (EU)
Clinical Project Manager (CPM) / Clinical Project Lead (CPL)
Since January 2015
- Manage, control and co-ordinate along with other project teams/members performing of clinical trial project lifecycle (initiate, plan, conduct, close).
- Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.
- Prepare and perform study-specific staff trainings; prepare study tools, review/update SOPs, customize applicable documents used in the study (different project management plans, study manuals, guidelines);
- Control of submission/ approval process and further correspondence with (C)ECs / RA by also providing inputs in pertinent documents finalization (Protocol, ICF, other patient related, ILs/ELs as applicable).
- Strict control over the compliance of all study milestones as per contract obligations followed via different KPIs and other metrics e.g. start-up submission timeliness, patients' enrolment (FPI/LPLV), data management compliance etc.
- Manage project budgets/costs/accruals;
- Manage contract process execution (CDA, SAA, MSA, SOWs/WOs, COs).
- Manage vendor selection (RFP, bidding, oversight of outsourced activity).
- Set up eTMF requirements and control the Central Filing process; Set up IxRS (IRT), EDC, Central LAB / IMAGING systems including UAT process.
- Participate and facilitate audits and inspections; Escalate findings and action plans to appropriate parties. Lead problem solving and resolution efforts (CAPA plan implementation).
- Organize and chair s study team meetings/teleconferences (kick-off, periodical).
- Prepare and conduct Investigator Meetings presentations, as requested.
December 2013 --- December 2015
March 2013 --- February 2014
Site Manager/Clinical Research Associate
April 2010 --- March 2013
Clinical Research Associate (CRA)
January 2009 --- January 2010
MSc Pharm ( central marketing sector and production sector )
January 2006 --- January 2009
Marketing Sector, Central - Participating in planning the strategy for focus products; Coordinator for company continuing pharmaceutical/medical licence educations(CPE/CME ); Key user for CRM ( Customer Relations Management ) software implementation Production Sector, Liquid and Solid forms - Supervising and assisting in production operations for solid and injection forms (including lyophilized injections in dual chamber vials “Act-O-Vial”, which are state-of-the-art production lines consistent with highest US regulations ) Ensuring • FDA • GMP • GLP compliance regulatred by company SOPs and required by law.
April 2006 --- January 2006
Serving patients by providing information and advice on health, providing medications and associated services ( internship period )
Phases of clinical development (phase I to IV)Project ManagementPharmaceuticalsClinical trials
Skills and Expertise
Communication Analytical skillsleadershiporganizationalProblem solving Create SOPs Interact with physiciansproject managementIdentify risksImplement Key Performance Indicators (KPI's)
Postgraduate academic study in Pharmaceutical Marketing and Management from Faculty of Pharmacy - University of Belgrade in 2009
Master degree in Pharmacy from Faculty of Pharmacy - University of Belgrade in 2006
Master in Pharmacy from University of Belgrade in 2005