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<pre>Array ( [var] => cut_url ) </pre> Resume for Daniela M. for Medical Doctor / Healthcare Professional / Healthcare & Social Assistance in Bucuresti, Romania. Search More Resumes for Medical Doctor / Healthcare Professional on Resumark.com #6FZWPQAG3
 

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Resume for Daniela M. for Medical Doctor / Healthcare Professional / Healthcare & Social Assistance in Bucuresti, Romania




Occupation: Medical Doctor / Healthcare Professional Industry: Healthcare & Social Assistance
Country: Romania City: Bucuresti
State: Bucuresti ZIP: 010337



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BD. magheru , Sc.b, et., ap. • bucuresti • telefon +
 
 
 

daniela M. 

date of birth 

      July

Nationality 

     Romanian

languages

        French, English, Italian – Fluent/Fluent

                  Spanish, German, Japanese – Conversational/Intermediate 

education 

                   – Bucharest Academy of Economic Studies

                        Master in Management of Small and Medium Companies MBA 

                   – Leads Management

                        Train the Trainers for Professionals 

                   RTH Consulting International, Bucharest

Time & Stress Management – Professional Techniques of time and stress administration 

                   RTH Consulting International, Bucharest

Diploma in Negotiation Advanced Strategies, Techniques and Tactics of Negotiation 

      RTH Consulting International, Bucharest

     Diploma in Behavioural Manipulation 

      University of Medicine and Pharmacy “Carol Davila”     Bucharest Diploma in Medical Sciences 

      Ecological University/Faculty of Medicine, Bucharest

     Graduate Degree in Medical Sciences 

                   St. Sava’s College, Bucharest

Professional activity 

– present – Clinical Investigations Group Ltd./Romania

    Medical Affairs Manager

International Project Management for phase IIIII and observational/epidemiological studies, harmonization and coordinating/training/coaching a team of more than CRAs and PMs; medical writing; business development 

– – PM freelancer, Clinical Research Consultant & Management Adviser 

– – PRSCLINICAL, Inc/Romania JSC

                Clinical Trials Manager & Country Manager

Startup activity beginning with based of the Romanian office; coordinating/training/coaching a team of CRAs, CTAs, accounting team, lawyer, administrative support person; coordinating phase IIIII studies; master list of doctors

  • Preparation and implementation of budget and yearplan, country strategy, business plan and business management
  • Decide on salaries within budget and propose for key functions
  • Authorize terminations
  • Sign report sent to the headquarter
  • Deliver rapid feedback, support and medical training to internal staff.
  • Organize periodically the medical tests in order to increase the team medical background in line with the company needs.
  • Initiate and perform meeting with KOLs and other decision makers in order to medically and scientifically support and initiate collaborations.
  • Provide medical documentation
  • Provide the specific medical information to the authorities if necessary.
  • Support force at clinical visits, congresses and other meetings.
  • Propose clinical sites for participation to international studies
  • Liaise for the HQ clinical studies monitor and/or for the contracted CRO companies.
  • Handling grants and investigator sponsored studies.
  • Ensure that a clinical studies system is provided in compliance with the company SOPs and national/European regulations in close collaboration with regulatory authorities
  • Updated on applicable regulatory requirements such as GCP, SOPs, company policies
  • Respect and apply the company travel policy, the company deadlines for the activity report by using the specific reports, the financial& accounting policies manage expenditures effectively.
  • Check regularly ELibrary once/week by using the relevant information’s in the specific work.
  • Initiates and coordinates feasibility assessment, potential investigator identification for a specific study and site selection for a specific study
  • Plans incountry sponsored trials forecasting, timelines, baseline recruitment
  • Strategically plans and coordinates study resourcing required FTEs and budget of feasibility and ongoing clinical trials 
  • Defines study specific incountry processes including study communication plans
  • Ensures all study staff understand study deliverables and timelines
  • Tracks incountry trial implementation, data collection and study reporting
  • Reviews and approves monitoring reports and Site Initiation Packages SIPs
  • Coordinates the collection of local study metrics and provides regular updates on study progress and study sponsors as required, identifying barriers to site activation and patient enrolment and identifying potential solutions
  • Responsible for insourcing/outsourcing decision for local MA studies 
  • Escalates studyrelated issues
  • Ensures quality of study execution
  • Ensures CRA gets necessary TArelated and studyrelated training 
  • Coordinates local studyrelated administrative tasks e.g. information to finance, status updates in local meetings 
  • Consolidates, develops and manages the study budget and resources 
  • Selects and evaluates performance of vendors for studies
  • Monitor and evaluate CRA's workload. Accompany and ensure that CRAs are accompanied on prestudy, initiation, monitoring and closeout visits and provide onsite training for CRA evaluation and to assess performance and/or additional training needs. These visits should be conducted until the CRA has demonstrated the ability to conduct visits unassisted
  • Initiate regular communication, : meetings and mentoring with all allocated CRAs according to set goals and coordinate CRA performance reviews and appraisals including obtaining feedback from PMs 
  • – – ASCENT Clinical Research Solutions Romania

    Head of Project Operations 

    Startup activity beginning with based of the Romanian office; coordinating/training/coaching a team of doctors, accountant, lawyer, administrative support person; coordinate phase I studies

  • Project manages local clinical study teams  
  • Defines CRA/CRS resourcing requirements for every study planned
  • Translates regional strategic objectives to the local level
  • Strategically communicates at the local level e.g. ML, DOM, MD and the      regional level CRME/MA e.g. program management
  • Liaises with study sponsors
  • Partners with MA colleagues to exchange site relationship information and to develop Key Opinion Leaders KOLs
  • Facilitates and maintains strong external relationships e.g. investigators, vendors
  • Identifies and highlights risk areas concerning operational readiness, communication and management
  • Maintain the administration, budgeting, monitoring, reporting, communication and liaison on all company affairs at a level acceptable to the board
  • Management, monitoring, reporting and communication in regard to financial and physical resources, administration and budgeting
  • Maintain and develop organisational culture, values and reputation in its markets and with all staff, customers, suppliers, partners and regulatory/official bodies.
  • Build and lead an effective and cohesive management team
  • Implement effective succession planning, people management, development, recruitment, and retention strategies
  • Manage the performance
  • Selfdevelopment and continuing personal development
  •  

    – ClinRom Med/Romania

                Country Manager 

    Startup activity beginning with based of the Romanian office; coordinating/training/coaching a team of CRAs, accountant, administrative support person; coordinating phase IV study 

  • Manage the operational and fiscal activities to include staffing levels, budgets, and clinical/medical goals.
  • Plan and develop systems,  solutions and procedures to improve the operating quality and efficiency
  • Coordinate and implement solutions from process analysis and general department projects.
  • Supervise staff in accordance with company policies and procedures.
  • Conduct interviews, hire new staff and provide employee orientation.
  • Coach and provide career development advice to staff.
  • Establish employee goals and conduct employee performance reviews.
  • Responsible for staff scheduling to include work assignments/rotations, employee training, employee vacations, employee breaks, overtime assignment, backup for absent employees, and shift rotations.
  • Assist staff to resolve complex or out of policy operation problems
  • Schedule, organise, supervise and conduct meetings, including Investigator’s Meeting.
  • – AbC.R.O, Inc/Romania JSC

         Senior Clinical Research Associate  

    Startup activity beginning with based of the Romanian office; coordinating/training/coaching a team of CRAs, CTA, accountant, lawyer, administrative support person; monitoring phase IIIII studies 

  • Responsible for the Investigator identification and Study Site selection activities
  • Design of study related documents such as protocols, case report forms, patient information sheets and informed consent documents
  • Supply of study specifics supplies for the study site.
  • Responsible for qualification, initiation, routine monitoring and study closeout of study sites
  • Organization and supervision of Study Site initiation visits
  • Development of new company SOPs and SOP amendments with senior management.
  • Preparation and submission of study related documents to the Local Ethics Committees and the Regulatory Authorities.
  • Liaison between the sponsor, Romanian National Drug Agency, study site and senior study management
  • Organization and completion of a routine monitoring visit
  • Preparation and completion of Closeout visits performing drug accountability and reconciliation.
  • Preparing the Pharmacy file documents for archiving
  • Writing appointment letters, monitoring reports and fo

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