International Project Leader (Global Project Director) @ From June 2015 to Present (7 months) Sr.Project Manager @ Management of the late phase (PASS) studies. From September 2013 to Present (2 years 4 months) Sr. Project Manager @ Mar 2012- t/n -Covance (in house); Sep, 2010 -
International Project Leader (Global Project Director) @ From June 2015 to Present (7 months) Sr.Project Manager @ Management of the late phase (PASS) studies. From September 2013 to Present (2 years 4 months) Sr. Project Manager @ Mar 2012- t/n -Covance (in house); Sep, 2010 - Mar, 2012 - Co-source/Pfizer, Vaccines.
Leed core project team and facilitate their ability to lead extended/complete project team.
Meet financial performance targets for the assigned clinical projects
Ensure project deliverables are met according to both Covance and client expectations.
Key client contact for assigned projects. From September 2010 to Present (5 years 4 months) United KingdomStart-up Manager @ Study start-up &Protocol amendment management:
• EC submissions (EU, Asia & Pacific, S. Africa)
• CTAs, budget
• IP release documents (review and approval)
• ICF (country specific modifications –EU, Asia - Pac, S. Africa). From May 2010 to September 2010 (5 months) Project Manager @ · Involved in the set-up, close-out and ongoing project management of International clinical trials
· Managing projects in accordance with internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfil all local regulations.
- Facilitating team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training.
· Maintaining effective communication with project team through oral and written correspondence, project status reports, and monthly progress reports, and ensuring adequate documentation of each communication.
· Maintaining and evaluating project progress by maintaining timelines and other tracking/analysis tools. Producing and distributing status, resourcing and tracking reports, and functional area plans, to appropriate team members and senior management.
· Establishing and maintaining good relationship with the Customers through the high quality of the performances and friendly way of the communication.
· Responsible for the feasibility studies ensuring that all selected sites/countries are suitable and in order to guarantee a quick start and high quality of the trial according to the GCP and ICH guidelines and capable to fulfil Sponsor's requirements on a site level with a good enrollment potentiality and high motivation.
· Managing selection of the Vendors and maintaining effective communication.
· Responsible for coordination of the Customer and Investigator Meetings. Takes a leading role at the Quick Start Camps.
· Responsible for the Project budget. Creating and negotiating the Work Orders internally within INC and with the Clients.
· Writing the Project Plans.
· Develop the ICF based on the Protocol and accordingly to the SOPs and country specific requirements.
· Managing CA/EC submissions with the cooperation of the Project Team and Regulatory management.
· Line management responsibilities. From May 2008 to April 2010 (2 years) Project Manager @ · Involved in the set-up and management of several large international clinical trials including sites in Russia, Central and Eastern Europe, Western Europe and US.
· Involved in the project management of several rescue studies and managed the project transition from another CRO and the implementation and integration of the ongoing study.
· Management/ coordination of global project teams
· Set up and coordinate/implement strategy for timely patient recruitment and retention during the study
· Stay within the agreed budget and timelines.
· Co-ordinate/provide support for the resolution of study data queries, issues at investigational centres, contacts with external clinical study services providers, including central laboratories, IVRS providers.
· Promote compliance with the Company's SOPs, ICH GCP and applicable laws and regulations
· Provide planning and management of the study budget including updates of tracking systems.
· Change Orders creation and negotiation internally and with the Client.
· CRO-CRO Transition Plan
· Project Plan writing.
· Report writing.
· Participating and conducting International Teleconferences within the project (with the study team / Sponsor).
· SMVRs review.
· GLPs review. (Green Light Packages/ drug release)
· Conduct/participate in Investigator's/ monitor's meetings.
· Training for the CRAs.
· Participate continuously in relevant training courses to improve personal/professional skills, provide study- GCP-specific training to investigators, monitors and/or relevant Company staff;
· Main point of communication with the Sponsor. From November 2006 to May 2008 (1 year 7 months) Project manager @ · Perform study feasibility for the clinical R&D studies (Investigational sites selection, agreements negotiation).
· Collaboration with Marketing Department for feasibility.
· Submit, coordinate and participate in timely obtaining of ethics and regulatory approvals.
· Set up and coordinate/implement during study strategy for timely patient recruitment and retention.
· Ensure collection of high quality study data.
· Coordinate/provide support for the resolution of study data queries, investigational centre's issues.
· Contacts with internal and external clinical study services providers, including central laboratories, IVRS, CRO, etc.
· Provide coordination and/or direct technical and logistic support for the conduct of clinical trials within the country, distribution, collection and destruction of the study materials.
· Management/ coordination of the project team. Project team typically included CRAs (1-3 GSK CRAs) and up to 5 outsourced CRAs (CRO), RAMOS (internal IVRS), Logistics officers, Regulatory manager, and Technical assistants. The size of the project team depended on the number of sites involved in the project (up to 30 sites) and the distance between the sites.
· Responsible for monitoring (17 sites (Urology study) for 2 years (2003-2005), 5 sites (RA study) - for 1 year (2005) From May 2005 to October 2006 (1 year 6 months) Project Manager/CRA @ From June 2004 to October 2006 (2 years 5 months) Medical Dept Logistic Officer @ · Supporting and providing Clinical trials with the supplies (study medication, lab.kits, CRFs)
· Finance (invoice tracking, purchase request submission) From December 2002 to June 2003 (7 months) Medical Representative @ · Promotion of the company products
· Performing meetings and presentations
- Providing the doctors with promotional information and materials. From November 2001 to December 2002 (1 year 2 months) Gynecologist /surgeon @ medical practice From September 2000 to December 2001 (1 year 4 months)
postgraduate, gynecology @ RMPA From 1999 to 2001 Physician, General medicine @ Russian Medical Postgraduate Academy From 1999 to 2001 GP @ Российский Государственный Медицинский Университет (РГМУ) From 1993 to 1999 Yulia Todd, MD, CPM is skilled in: Clinical Trials, CRO, Vaccines, Line Management, Pharmaceuticals, Physicians, Financial Management, Negotiation, Pharmaceutical Industry, GCP, ICH-GCP, Clinical Research, Sop, CTMS, Clinical Monitoring
Looking for a different
Yulia Todd, MD, CPM?
Get an email address for anyone on LinkedIn with the ContactOut Chrome extension