Менеджер проектов (клинические исследования)

Описание

Curriculum Vitae
Anna Pavlova, MD
Contact information:
e-mail: pavlovaad@mail.ru
phone: +79060336384

Location: St-Petersburg, Russia



Professional Experience:
June 2021-present
Parexel International RUS
Clinical Operations Leader (Regional and Global)
Key responsibilities:
Manage the study start up process within assigned Regions to the successful sites' activation in compliance with ICH GCP
:: Act as primary contact from Global Team side for Clinical Research Associates (CRAs)
:: Establish and maintenance excellent working relationships with assigned CRAs including their trainings, mentoring and management of hand over processes
:: Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions and quality are maintained
:: Provide performance feedback on team members as appropriate
:: Collaborate with other departments as needed to meet deliverables of the project
:: Forecast and manage resource needs to ensure proper CRAs'
:: Review of submitted CRAs' time reports to assure conducting the study within assigned Regions per agreed budget to ensure accurate financial profibality
:: Assure proper planning of Monitoring Visit per Monitoring Plan, budget and ad-hoc needs
:: Review and approve Monitoring Visit Reports submitted by CRAs, identify issues and/or trends across a study and implement appropriate corrective /preventive actions
:: Coordinate the Site Initiation Scheduling, EC & RA/ MoH Strategy, ICF Customization progress, Contracts negotiations, Risk Mitigations, Site Activation Requirements & Relevant Tools
:: Collaborate and communicate within the Global study team matrix to provide input to milestone development and alignment of operational targets to ensure timely delivery of study start up activities
:: Oversee maintenance and quality check of Central Files at assigned level
:: Identify changes in scope and liaise with Project Leader
:: Participate and lead client, investigator and team meetings

April 2019 - June 2021
Odonate Therapeutics
Regional Director, Clinical Operations
Key Responsibilities:
:: Accountable for overall Clinical Operations activities within the respective region: Russia, Czech Republic, Lithuania, Bulgaria;
:: Serve as clinical operations lead for a region, a study and/or process or activity;
:: Manage and oversee activities of CRAs to ensure the successful start-up, monitoring and execution of Phase I-III Oncology trials in respective region;
:: In conjunction with CRAs, communicate with investigators and site staff on escalated issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance;
:: Work with relevant team members to identify appropriate corrective actions to resolve site performance or quality issues in a timely manner and to follow through until completion;
:: In conjunction with the Vice President of Clinical Operations, create and maintain study level clinical monitoring plans, study start up plan and feasibility form;
:: Report and track pertinent study information and proactive communication of progress and issues to key stakeholders;
:: Review, support and contribute to appropriate metrics related to clinical trial conduct;
:: Oversee feasibility and site identification activities in designated region for new clinical studies; as appropriate, identify sites within the region for participation on clinical studies;
:: Manage start-up and maintenance activities for designated region including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments);
:: Oversee communication with appropriate site staff involved in start-up and IRB/EC submissions in respective region;
:: Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for sites in designated region in collaboration with clinical project management and finance;
:: Ensure that CRA clinical site management and monitoring activities are performed in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines;
:: Oversee CRAs remote data review, query resolution and action plans;
:: Review of monitoring visit reports for sites in designated region in accordance with clinical monitoring plan and relevant SOPs;
:: Generate resource allocation plans including CRAs, including personnel requirements for designated region;
:: Onboard, train, coach and mentor CRAs assigned to designated region;
:: Ensure team member completion of GCP and internal training in a timely manner;
:: Develop performance measures and evaluate CRA performance and quality of work via periodic co-monitoring visits and evaluation of performance measures;
:: Develop and cultivate strong site relationships and ensure continuity of site relationships;
:: Ensure follow up and close-out of all issues identified in monitoring visit reports for assigned region;
:: Ensure sites within assigned region are inspection ready;
:: Conduct risk assessment categorization activities with cross-functional study teams, including protocol and site-level risk assessments;
:: Facilitate and support investigator site audits and/or inspection activities;
:: Review clinical study documents, including study protocols and provide feedback as pertinent to clinical operations;
:: Contribute to overall clinical operations team knowledge by sharing best practices and leading improvement initiatives.
October 2017- April 2019
Odonate Therapeutics
Associate Director, Clinical Site Relationship Manager
Key Responsibilities:
:: Develop and maintain key strategic relationships with investigators participating in Odonate clinical studies as well as regional and global site networks or cooperative groups as applicable within respective region: Russia, Ukraine, Spain, France, Germany, Italy.
:: Responsible for clinical support of sites to ensure achievement of site level enrollment and recruitment targets through active engagement with Principal and Sub-Investigators;
:: Accountable for meeting all site level operational deliverables and meeting metrics targets in accordance with quality and time commitments;
:: Provide support of Clinical Research Associates (CRAs) as needed ensuring study site compliance with protocol procedures (e.g. compliance with data entry, query resolution, adverse event reporting, adherence to study procedures) and compliance with principles of ICH GCP;
:: Ensure adequate performance and productivity of site (e.g. enrollment delivery to site commitment at pre-study visit/site initiation visit, contracting/start-up timelines, timeliness of data entry and query responses);
:: Support activities related to initiation of clinical study sites including participation in site initiation visits as required;
:: Collaborative interaction and problem solving with CRA/Clinical Research Organization staff as applicable;
:: Provide site level support of Odonate medical staff in matters requiring site interaction or resolution of issues;
:: Support regional key opinion leaders and collaborate with internal stakeholders in prioritization and alignment of global interactions and activities;
:: Identify regional and national patient support and advocacy groups related to overall company efforts;
:: Responsible to devise and implement optimal site visit plan to provide proper oversight and ensure optimal site relationships;
:: Contribute to internal planning related to clinical development, commercial and regulatory planning from regional perspective;
:: Collaborate with internal and external stakeholders to ensure execution to clinical study plan while maintaining compliance with Odonate policies and procedures;
:: Ensure high quality implementation of Odonate clinical trials within the assigned region as required (internationally and domestically);
:: Attendance at relevant regional investigator meetings and scientific conferences (ASCO,SABCS, ESMO, ECCO, etc.) as requested.

February 2017 - September 2017
Gaea Clinical LLC
Role: Clinical Trial Manager
Key Responsibilities:
:: Management of the clinical trial process from project start. Respective region: Belgium, Germany, Italy, Spain, UK, France and Finland.
:: Leading CRA team to ensure project timely achievement of project deliverables;
:: Monitoring visits report review;
:: Study budget review;
:: Essential Document Pack review and approval;
:: Assistance in the identification of project staff, conduction of a qualification interview: CRAs and CTAs.
:: Conduction of project training to CTA/CRA Management of the CTAs and CRAs: site assignments, priority and required quality;
:: Review /development of project plans and documents of relevance: lead the Clinical Trial Management (Monitoring) plan;





November 2015 - February 2017
IQVIA (QuintilesIMS)
Role: Associate Line Manager (Real World and Late Phase Research)
Respective region: Germany, Hungary, Russia, Finland, Denmark, Ukraine, Sweden.
Key Responsibilities:
:: Managing International Team of Clinical Research Associates (CRAs) and Site Managers (SMs). Respective region: Germany, Hungary, Russia, Finland, Denmark, Ukraine, Sweden;
:: Participate in the selection and onboarding process for new SMs/CRAs by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources
and Learning and Development training programs.
:: Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
:: Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training.
:: 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 deficiencies in performance of staff.
:: Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.







June 2012 - November 2015
QuintilesIMS
Role: Senior Clinical Research Associate (Sr. CRA)
Since 10/2014 till 10/2015: Sr. CRA in Real World and Late Phase Research
Apart from regular Sr. CRA responsibilities, in Real World Late Phase Research Department full Start Up activities were performed:
Submission of Study documents to Independent Interdisciplinary Committee;
Submission of Study documents to Local Ethics Committees;
Contract negotiation;
Payments to Investigators and sites.
Since 06/2012 till 10/2014 Sr. CRA in Global Functional Resourcing Department
Key Responsibilities:
:: Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
Therapeutic areas of experience:
Infectious diseases (HCV - phase III, Tuberculosis - phase III, nosocomial infections - phase IV); COPD (phase II); Asthma (phase IV); DM (phase IV); Rheumatology (phase IV)

June 2011 - June 2012
Novartis Pharma
Role: Clinical Research Associate

Key Responsibilities: :: Site Monitoring Activities, :: Conduction of Site Initiation Visits, :: Conduction of Close-Out Visits, :: Conduction of Site Selection Visits, :: Site Feasibility
:: Submission of trial-related documents to LECs, :: Order of trial supplies and equipment, :: Site and Investigators' payment management, :: Participation in Investigator Meetings, :: Participation in Local Medical Departments Meetings.
Therapeutic areas of experience:
Cardiovascular Disease (phase III - 2 trials); Gout (phase III).
October 2009 - June 2011
Parexel International RUS
Role: Clinical Trial Assistant
Key Responsibilities: In-house support for CRAs: document management, payment management, submission of documentation to Regulatory Authorities and LECs, ordering re-supply trial-related materials for the sites, QC of trial-related documentation.
Therapeutic areas of experience:
Lung Malignant Tumors (phase II); Rheumatology (phase III); Alzheimer's disease (phase III - 2 trails).
Education
St-Petersburg State University, Medical Faculty (2000-2006)
Specialty: Pediatrics (Internship 2006-2008)