Experience

Medannex Ltd

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Project Director

  • Jul 2020 - Present

  Responsible for implementing and delivering Medannex's clinical development programme in Oncology. Responsible for implementing and delivering Medannex's clinical development programme in Oncology.



IQVIA Biotech

• Biotechnology Research
• 1 - 100 Employee

• Project Director

  • Jan 2020 - Jun 2020

  • Accountable for the strategic development and execution or delivery of clinical studies in line with agreed upon contracts while optimizing speed, quality and cost of delivery, ensuring compliance with system updates, standard processes, policies and procedures.• Primary project oversight and/or contact with customers and own relationship with the project's key customer contact(s), communicate/collaborate with IQVIA business development representatives as necessary.• Set objectives for the core project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance, providing feedback and leadership.• Monitored progress against contract and prepare/present project information proactively to all stakeholders internally and externally.• Supervised problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate risks.• Coach and/or mentor junior team members around project delivery, planning, project review, risk management and problem solving to ensure alignment of work practices across the team.• Achieved project quality by identifying and proactively managing quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.• Participated in executive committees as part of program leadership.• Ensured the financial success of the project including optimal management and assignment of resources to achieve project goals and profitability.• Forecast and identify opportunities to accelerate activities to bring milestones and revenue forward, implement appropriate actions to achieve.• Identified changes in scope and managed change control process, including securing customer agreement to financial and milestone updates as necessary.• Identified and communicated lessons learned and best practices to promote continuous improvement.



NuCana plc

• United Kingdom
• Biotechnology
• 1 - 100 Employee

• Senior Project Manager

  • May 2014 - Dec 2019

  • Responsible for implementing and delivering NuCana’s global clinical development programme in Ovarian Cancer.• Set-up, initiation and management of Phase I, Phase II and Phase III Oncology clinical studies . These are both Company Sponsored and Investigator Sponsored Studies. Hands-on, day-to-day management to ensure adherence to timelines and generation of exceptional data. • Select and manage CROs to provide high-quality deliverables within established timelines and budgets.• Responsibility for the financial management of the clinical development programme including budget planning, tracking, reconciliation and risk management.• Manage and further strengthen relationships with KOLs/investigators, in 1 to 1 meetings and advisory boards.• Document preparation and review for IND aplications• Prepare and submit competent authorities and ethics applications.• Clinical study design and protocol development, including adaptive study designs.• Develop and maintain key clinical study documents, including Investigator Brochures, Protocols, CRFs, DSURs, Pharmacy Manuals and Clinical Study Reports.



PPD

• United States
• Research Services
• 700 & Above Employee

• Project Manager

  • Sep 2012 - May 2014

  Managed the global project deliverables for a clinical studies. Tasks and responsibilities included:• Plan and implement, to achieve, anticipated and unexpected project deliverables.• Analyse and oversee cost, personnel hours and project needs to determine the most cost effective and efficient means to run and complete projects successfully on time, to agreed quality standards and within budget while meeting the Customer’s needs and adhering to the contract.• Delegate assigned responsibilities to project team members.• Have regular and proactive liaisons with Department Heads to optimize performance and utilization of the project team members.• Anticipate potential issues and escalate appropriately/pro-actively to their Franchise Director/Associate Director.• Act as primary contact with Customer throughout study. Up to delivery of final project product(s).

• Senior Clinical Team Manager

  • Apr 2012 - Aug 2012

  Performed the role of Clinical Study Manager for North America with reporting responsibilities to the Global Project Manager. This role involves serving as the sponsor’s primary contact in that region and requires that in addition to managing the clinical deliverables, there are management responsibilities for all contracted North American functional groups and their deliverables.

• Clinical Team Manager

  • Jul 2010 - Mar 2012

  Managed the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a large clinical trial and multiple smaller trials.

• Senior CRA

  • Sep 2008 - Jun 2010

  Performed all aspects of monitoring which includes feasibility, Pre Study Evaluation Visits, Initiation Visits, Interim Monitoring and Close Out visits. My responsibilities include training of site staff in the protocol and ICH GCP, reviewing essential documents, source verification of CRFs, SAEs and queries, reviewing investigational product accountability and general site management for the duration of the study

• Senior CRA/ CRA2/ CRA

  • Nov 2005 - Aug 2008

  Performed all aspects of monitoring which includes feasibility, Pre Study Evaluation Visits, Initiation Visits, Interim Monitoring and Close Out visits. My responsibilities include training of site staff in the protocol and ICH GCP, reviewing essential documents, source verification of CRFs, SAEs and queries, reviewing investigational product accountability and general site management for the duration of the study

• Research Assistant

  • Sep 2004 - Sep 2005

  A year long CRA training program combined with project work. Tasks and responsibilities included:• Administrative support to Project Manager, CTM and CRA. • Communication with client regarding approvals for costs and maintenance of the client tracker. • Maintenance of study master file, country file and in house investigator site file. • Meeting minutes for client and team calls.• Assisted CRA in the update of project specific trackers, preparation and review of documents prior to UK Ethics submission and internal regulatory review. • Created study specific investigator site file forms and source document worksheets.• Tracking and distribution of data management and medical monitor queries

• Data Processing Technician

  • Feb 2004 - Sep 2004

  As part of the data management team my tasks and responsibilities were:• Performed tracking and entry of CRF data following study specific guidelines. • Assisted in the testing of databases and data entry screens. • Performed quality control activities and assists in the archiving of study documentation.

• Clincal Data Associate

  • Aug 2002 - Dec 2002

  As part of the data management project team my tasks and responsibilities included:• Performed checks on the clinical data in accordance with the study specific guidelines to ensure its validity. • Performed quality control activities and ensures all necessary documentation is created and filed correctly. As part of the data management project team my tasks and responsibilities included:• Performed checks on the clinical data in accordance with the study specific guidelines to ensure its validity. • Performed quality control activities and ensures all necessary documentation is created and filed correctly.