Ana Petrović

- Ensure project deliverables according to agreed timelines and milestones, including study set-up, feasibility, site selection, execution and closure, as well as vendor set up/ execution activities.

- Build the cross-functional project team, manage cross-collaboration of the team to support milestone achievement and to manage study issues and obstacles.

- Ensure the financial success of the project, identify opportunities to accelerate activities to bring revenue forward, identify changes in scope and manage change control process.

- Monitor progress against contract, present and discuss project to internal and external stakeholders such as Lead CRA, Data Manager, Biostatistician, Regulatory SU Manager, Site Contract Specialist, vendors, site staff when applicable, customer.

- Ensure inspection readiness through compliance with the clinical research protocol, SOPs, ICH-GCP, ISO 14155, applicable regulations and guidelines from start-up through close-out. Takes ownership for assigned responsibilities.

- Develop study plans and other documents/materials as required including study tools and training materials.
- Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning and implementing corrective and preventative action plans.

- Manage risk and contingencies proactively and lead problem solving and resolution efforts.

- Set objectives of the core project team according to agreed upon contract, strategy and approach, and assess their performance.
- Identify lessons learned and implement best practices. Provide input to line managers about project team members’ performance relative to project tasks.
- Support staff development and mentor less experienced project team members.

Therapeutic experience:

- Cardiosurgery, medical device study in severe symptomatic aortic stenosis, postmarketing study, 14 countries across Europe

- Dental medicine, bleeding control after dental extraction, postmarketing study, 7 countries across Europe and North America

- Manage study start-up activities and develop project plans

- Monitor study timelines

- Evaluate and identify resourcing needs, continuous monitoring on resourcing. Provide performance feedback on team members and ensure appropriate handover between project team members.

- Address identified and escalated site issues and drive to closure. Implement and investigate process improvements within the project.

- Participate in client, investigator and team meetings.

Therapeutic experience:

- Nephrology/Cardiovascular, Chronic kidney disease with uncontrolled hypertension, phase III, 6 countries across Europe and South Africa

- Gastroenterology, Crohn's disease, phase Ib, USA

- Responsible for provision of Client's deliverables on-time, within budget and scope and with required quality and KPIs for assigned projects

- Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services (e.g. Regulatory and Safety Department, Finance Department, Quality Assurance and Training Department etc.)

- Contribute to proposal strategy, development, costing, and bid defense for assigned business development opportunities

- Ensuring that all Project Team Members are adequately trained in project specific trainings, such as client SOPs, project plans, study protocol and all other relevant project specific documentation and that any identified training gaps are adequately followed up and adequate re-training plan implemented and executed

- Ensure project risks are discussed at project reviews. Monitor and control the risk plan and provide ongoing oversight to ensure mitigation plans are in place and working. Escalate risks newly identified by the project team to stakeholders.

Therapeutic experience:

- Oncology, AML and MF, phase I, Italy, Croatia and Israel

- Oncology, SCLC, phase Ib/IIa, unblinded CTL for 7 countries across Europe

- Oncology, pancreatic cancer, phase III, internal CPM Serbia

- Psychiatry, schizophrenia, bioequivalence, internal CPM Serbia and Croatia

- Oncology, colon cancer, phase II, internal CPM Hungary

- Named Patient Program, SCLC, Serbia

- Maintain a detailed overview of the project and ensure that all activities are proceeding as anticipated, both with respect to time and budget. Ensure that appropriate remedial action is instigated in a timely manner

- Set up and maintain a detailed overview of monitoring activities

- Host and/or participate in site quality visits, audits and inspections, as applicable

- Budget negotiation/split and contracts negotiation

- Perform other duties as assigned

Therapeutic experience:

- Oncology, SCLC, phase Ib/IIa, unblinded CTL for 7 countries across Europe

- Oncology, pancreatic cancer, phase III, internal CPM Serbia

- Oncology, AML and MF, phase I, Italy, Croatia and Israel

- Psychiatry, schizophrenia, phase III, internal CPM Serbia (4 projects)

- Psychiatry, schizophrenia, bioequivalence, internal CPM Serbia and Croatia

- Cardiology, ACS, phase III, internal CPM for 2 countries in Europe and Georgia

- Gastroenterology, ulcerative colitis, phase Ib, internal CPM for Georgia

- Performed routine site visits, including pre-study, initiation, interim monitoring and closeout visits at investigational sites in accordance with protocol, applicable SOPs, project related guidelines, ICH-GCP and relevant regulatory guidelines. Each visit is followed by visit reports' preparation and submission.

- Managed assigned sites by regular contacts with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements

- Identified deficiencies and/or discrepancies related to source documents and Case Report Forms (CRFs) and working with the investigator and site personnel on resolution, independently performing CRF review, identifying document in writing and adequately follow up with the site personnel and Client/Sponsor all protocol deviations, regulatory and GCP non-compliances

- Recruitment of potential investigators, preparation of EC submissions and notifications, negotiation of study budgets with potential investigators/institutions and assistance with execution of site contracts

- Reported to project team and/or Client/Sponsor and site personnel any findings noted during site visits, maintenance and management of the relevant project tracking systems, maintenance of study files and ensuring that files are up-to date and accurate.

Therapeutic experience:

- Oncology, Melanoma, phase III

- Psychiatry, Schizophrenia, phase III

- Psychiatry, Bipolar disorder, phase III

- Cardiology, Angina Pectoris, phase III

- Cardiology, AMI, phase IIa

- Endocrinology, Diabetes mellitus 2, phase III

- Hematology, B-cell lymphoma, phase II

- Urology, Neurogenic Detrusor Overactivity, phase III

- Psychiatry, Acute Exacerbation of Schizophrenia, phase III

- Pulmology, Asthma, phase IV

- Psychiatry, MDD, phase III

- Cardiology/Endocrinology, Cardiovascular outcome trial

- Conducted studies from feasibility, start up through monitoring. Performed pre-study visits, initiation, monitoring, unblind monitoring and trained for close-out visits.

- Preparation and submission of regulatory documents in accordance with the Serbian legislation and involved in contracting process including obtaining import/ export licenses

- Participated in company-required training programs

- Performed necessary administrative functions (e.g. tracking of expense reports, reporting of time and attendance)

- Performed other related duties as assigned

Therapeutic experience:

- Rheumatology, Osteoporosis, phase III

- Oncology, NSCLC, phase III

- Oncology, Colorectal Ca, phase III

- Nephrology, Anemia in kidney failure, phase III

- Cardiology, AF, phase III

- Cardiology, ACS, phase III

- Cardiology, AHF, phase II

- Assisted to CRA within CTA duties: collection of site documentation, preparation of submission packages, preparation of site files, filing.

- Assisted with IM organization

- Participated in company-required training programs

- Performed necessary administrative functions (e.g. tracking of expense reports, reporting of time and attendance)

- Performed other related duties as assigned

Therapeutic experience:

- Oncology, Glioblastoma multiforme, phase III

- Neurology, Multiple Sclerosis phase II