Clinical Trial Project Manager

• Aug 2021 - Present

Project Manager

• Jan 2021 - Aug 2021

Project delivery• Oversee the delivery of major research, training and project activities, ensuring they are managed to business requirements, specification, time and budget;• Provide day-to-day high-level support to the PI, assisting in the implementation of robust program management processes and protocols, in line with best practice, as well as deputizing for the PI as appropriate;• Deliver project events, such as research collaboration meetings, road-mapping and coordinate appropriate publicity, ensuring meeting minutes are taken and distributed;• Routinely monitor all activities, review risks, issues and progress, taking actions as necessary to ensure minimum impact on program deadlines;• Maintain up-to-date records that enable effective monitoring, control and evaluation of assigned program activities;Operations and resources management• Perform strategic project resources planning and financial analysis, including assisting in preparation of budgets, to include staffing and operational needs, as well as manage the payment of expenses;• Coordinate the delivery of strong project governance, through supporting the management of advisory board meetings, as well as required scientific and other stakeholder workshops and summits, as needs arise;Communications and relationships management• Communicate project information and status to all relevant parties, providing early warning and escalation of key issues to the PI and associated Institute senior management;• Act as a primary contact point for all internal and external partners and ensure strong business relationship management;• Work with Institute Partners, sponsors and researchers to ensure project portfolio is visibly relevant and integrated into current Turing strategies and policies;• Work with the Institute’s communications team to develop powerful case studies, highlighting successful outputs and outcomes of the projects;

Research Project Manager

• Jan 2018 - Jan 2021

Providing direct input into strategic planning, development management processes, and project management from conception through development cycleWorking closely with regulatory specialists to manage protocols, perform continuing reviews and accrual updatesDeveloping costing, budget, legal contract and provide input into proposalsReviewing project progress and adjusted project timelines accordinglyDeveloping and implement clinical study procedures and strategiesEnsuring essential documentation and recording of patient's research data in appropriate files as per institutional, and regulatory requirementServing as a primary point of contact for the research participants, pharmaceutical sponsors, and regulatory hospitals to coordinate collection of study reports as well as advertise the trials to recruit participantsEstimating funds necessary for the clinical trial, and finding sponsors for fundingPerforming various clinical research duties such as coordinating services, scheduling procedures, creating and maintaining case packages, and monitoring Handling and assisting with the administrative activities associated with the clinical trials by reviewing medical records or conducting screenings for recruitment of study patients with the help of interviews and QOL questionnairesProviding guidance to data analysts on analytical plan and conduct data management for the study, in collaboration with biostatistics and/or a study data analystLeading/managing medium to large size projects, leveraging basic project management tools to deliver resultsMaintaining ongoing communication with the vendors and sites regarding all study related materials and issues to ensure all materials are up to date.Preparing for meetings and teleconferences (e.g. creating slides, agendas, travel arrangements, budget projections, meeting invitations, study reports, and minutes) with internal and external partners both locally and internationally across various time zones.

Project Manager

• Mar 2016 - Oct 2017

Performed Clinical trial start-up activities, including site initiation visits and team training;Served as the primary contact with the sponsor for all study related items, with oversight of all aspects of trial conduct, from study start-up through close-out in accordance with study protocol and Health Canada regulations, project specific SOPs, guidelines, budgets, timelines and contracts;Ensured operational plans are developed consistent with program needs, including but not limited to, the development of communication plans, monitoring plans, project plans, training plan, study timelines and clinical management plans; monitor project progress as compared to established plans and ensure compliance with plans;Supervised project management staff in execution of assigned studies;Ensured project training occurs;Served as a resource to team members for all inquiries and issue resolution for site management, contract budget and remediation, and regulatory document preparation;Ensured project budget is tracked against contract milestones;Assessed resourcing needs throughout the trial;Managed trial sites, including identifying issues and resolving them quickly, escalating problems and concerns to the appropriate TDRA personnel in a timely manner;Review of trial data on an ongoing basis and identifying trends or concerns;Reviewed site visit reports and letters and other trial documents;Provided TDRA with regular updates on trial status;Facilitated timely progress in key trial areas and metrics, including screening, enrollment and other pertinent metrics;

Clinical Research Associate (contractor)

• Nov 2015 - Jan 2016

Responsible for ensuring that clinical investigative sites: protect the subjects rights and safety, adhere to clinical protocols, Standard Operating Procedures, ICH guidelines, Good Clinical Practices and FDA guidelines;Conducted Site Initiation, Routine monitoring and Site Close-Out Visits;Reviewed regulatory documents, investigation product accountability, Case Report Form source document verification and prepare site visit reports;Assisted in collecting data management queries and data clarification forms;Instructed investigator site staff in their responsibilities and ensures compliance with GCP and ICH guidelines;Worked in conjunction with the in-house project teams to ensure that sites have adequate study drugs and supplies;Identified and evaluated potential investigation sites, documenting and routing appropriately concerned departments;Tracked and monitored enrollment at the sites, initiating additional recruitment strategies as required;Submitted monitoring reports per SOP;Reviewed investigator files to verify that the site complies with FDA regulations and internal SOPs;Reviewed study files and update tracking information reported for key study forms;Determined availability and completeness of study files and identifies deficiencies;Input and maintained electronic site management systems;Assisted in updating study trackers and ensures accuracy against clinical database;Managed several study protocols at one time;Responsible for accurate and timely data collection, documentation, entry, and reporting;Development of action plans to improve quality;Provided instruction and management to staff of lower grades and train research staff;

Clinical Research Coordinator/Site and Data Management

• Nov 2014 - Oct 2015

Liaised with Contracts and Finance departments, National Leaders, Site Management Coordinators, and site staff to develop clinical trial agreements, complete regulatory/ethics submissions, and process payments for sites and national leader office staff;Identified site issues and initiate correction plans based on monitoring plan and action item reports;Provided study status updates to team members and project manager, including interaction to resolve site issues and facilitate project timelines;Coordinated logistics, review requirements, and confirm accuracy for the shipping and collection of materials and supplies for the main study as well as for sub-studies;Proofread study materials and protocols;Found suitable monitors for the study;Provide all necessary documents to perform the monitoring visit. Review and processed the monitoring visit data and documents;Compiled and reviewed monitoring documentation required for Good Clinical Practice and/or as required from the study sponsor;Contributed to the coordination and management of sub-studies, including the distribution of supplies and all unique aspects of the sub-study;Implemented protocol amendments in consultation with the Research Coordinator;Responded to study-related questions from internal and external partners;Revised, troubleshoot, and edited edit-checks to maintain their functionality;Supported Research Coordinator to oversee the management and reporting of data;Requested and reviewed reports from the Statistics Department to maintain data integrity of the study;Coordinated the process of transferring prepared study data to the study sponsor (if other than PHRI) at regular intervals;Responded to data-related questions from internal and external partners;

Research Assistant

• Aug 2013 - Oct 2014

Developed research protocol;Abstracted Data from patient charts;Validated quality of data elements/data editing;Evaluated consistency of nutritional data;Provided computational research support;Performed studies as related to research project;Diagnose and problem solve as it relates to the research project;Coordinated clinical trials;Conducted screens and assays;Recruited and enroll study participants;Wrote protocols and informed consents;Performed study scheduling;Tracked patient participation;Conducted literature searches;Administered patient interviews and preparing assessments;Preparation of tissues, cell cultures, blood samples, etc. for testing;Training of laboratory personnel in experimentation techniques;Conducted phage displays (bio-panning technologies);Modified, tested, verified and analyzed research data;Tabulated research data;Recorded results of experiments;Interviewed human subjects participating in a clinical trial;Developed research survey, questionnaire, or tests;Prepared research manuscripts and research presentations;Developed and maintain research databases;

Research Assistnat

• Oct 2012 - Aug 2013

Recruited, screened and booked study participants for long-term clinical trial;Created clinical project documents according to the protocol, including but not limited to, source; documentation forms and guidelines, monitoring Standard Operating Procedures and reportsImplemented and monitored clinical trial to ensure sponsor/investigator obligation are met and are; compliant with applicable local requirements and FDA and ICH guidelines Conducted chemical analysis of food samples/ingredients;Managed and supervised work-study students, research volunteers and study nurse;Assisted graduate students and postdoctoral fellows with experiments including blood and urine collection for analysis of relevant biomarkers;Provided nutrition counseling regarding healthy eating and energy restriction;Conducted literature searches, reviews and maintaining literature databases;Maintained communication with study participants to confirm appointments and follow-ups regarding study guidelines;

Research Associate/ Dietitian Assistant

• Apr 2010 - Oct 2012

Educated and advised a wide range of patients with dietary-related disorders on the practical ways in which they could improve their health by adopting healthier eating habits;Calculated patients' nutritional requirements using standard equations based on assessments of blood chemistry, temperature, stress, mobility and other relevant factors;Gathered and organized nutritional information;Provided assistance in determining BMI, Waist circumference and calorie counting;Conducted 24 hour and 3-day dietary assessments; Planned dietary meals for patients with heart disease (CVD), hypertension and diabetes; Performed meal planning through Data Analysis (plus 8.0) Program;