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Work Background
The Medical Affairs Company (TMAC)Clinical Trial Liaison
Aug. 2020London, England, United Kingdom
Bristol Meyers Squibb MedicalClinical Project Manager II
Jul. 2018 - Apr. 2021Uxbridge, Greater London, United Kingdom
The Insight of an AuthorCEO
Jan. 2017Nigeria
ICON plcField-based Senior Clinical Research Associate (freelance)
Dec. 2013 - Mar. 2018Field-basedField-Based Senior Clinical Research Associate: (Therapeutic Area: Oncology (Lymphoma-Phase III, Prostate Cancer – Phase II) • Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies.
• Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP. • Involvement, when required, in other areas of study management and staff training.
• Contribute to the review of ICON systems and procedures, as appropriate.
• Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues. • Contribute to the culture of process improvement with a focus on streamlining ICONs processes adding value to our business and meeting client needs.
• Recognize, exemplify and adhere to ICON’s values which centre around a commitment to People, Clients and Performance.
• Independently and proactively coordinate the necessary activities required to set up and monitor a study.
Ipsen Clinical Research Associate III Therapeutic Area: Uro-On Area: Uro-Oncology (Prostate cancer)
Nov. 2012 - Oct. 2013Slough, United Kingdom• Organising and participating in Investigator and Monitors meetings.
• Vendor Selection.
• Completing and collating documents for submission to Research Ethics Committees (IRAS) in accordance with specific guidelines.
• Approving the final selection of investigational sites.
• Securing the supply of investigational medicinal products (IMPs).
• Preparing, monitoring and managing study budgets for assigned clinical trials.
• SOPs, guidelines and ICH Good Clinical Practice guidelines
• Ensuring all of the necessary approvals and documentation are in place for each study site prior to authorising the start of recruitment, or the despatch of IMP to the site.
• Circulating regular progress reports for assigned clinical trials to relevant individuals within Ipsen.
• Ensuring that studies are conducted recorded and reported within the agreed timelines and budget, and in accordance with applicable SOPs, ICH-GCP and other applicable regulations and guidelines.
• Writing/reviewing clinical study reports and where appropriate manuscripts or drafts for publications.
• Providing leadership to study specific monitoring team and coordinate monitoring activities.
• Performing project management tasks delegated and may also deputise for the project manager in his/her absence.
• Identify CRA performance issues and communicate issues to appropriate project manager.
• Conducting monitoring visits as required.
• Developing any necessary aids to allow studies to proceed expeditiously (e.g. newsletter, investigator flow charts).
• Ensuring continued supply and accountability of IMP.
• Tracking investigator's and CRO’s expenses against contractual agreements. Updating Ipsen’s electronic databases.
• Ensuring any data queries are resolved and returned to data management in a timely manner.
• Ensuring remaining data are collected promptly to allow prompt database lock.
• Closing down investigational centres as soon as possible following database lock.
PfizerFreelance Clinical Research Site Manager
Jan. 2011 - Apr. 2012homebasedField-Based Clinical Research Site Manager: (Therapeutic Area: Oncology (Phase1 & 2) and Vaccine (Phase 3)).
• Conduct SDV and ensure clinical trials data is submitted to data management in a timely fashion, with supervision.
• Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team, with a Responsible for all aspects of site management from collaboration on site selection to study close-out, with appropriate mentoring and support .
• Ensure studies are run in line with ICHGCP, the UK Statutory Instrument and Pfizer SOPs and procedures
• Manage a number of studies and investigator sites commensurate with experience, with supervision, so that studies are run efficiently, and key study objectives are met • Interact with health care professionals in a manner which enhances Pfizer’s credibility with the customer.
• Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred.
• QC relevant documents on ELARA in a timely manner.
• Maintenance of ELARA to ensure audit trail is complete and accurate.
• Function as mentor for Junior CRA team members.
• Maintain accurate site-level information on corporate clinical trials registry.
• Assist CTA in gathering IIP documentation where required to ensure timely site set up.
• Obtain critical information to enable generation of IIP documentation.
PR RESEARCHManaging Director
Jan. 2010 - Sep. 2014Croydon, United Kinhgdom-Organization: Organization chart; Job descriptions, Authority levels
-Management recruitment and development: Succession planning, in-house training, outside training, promotion from within, human resource plan, new positions, active recruiting
-Policy: Corporate policies, new policies, management input, review
Standards of performance and performance reviews: Standards of performance, performance reviews, performance improvement plans
-Controls: Monthly reports, quarterly reviews, supplemental action programs
-Management morale: Involvement in planning, salary discussions, access to CEO, management turnover.
-Product development: Overall strategy, quarterly priority meetings, status reports, new products, development expense
-Community relations: public relations, community participation.
-Planning: Overall company strategy, Strategic Plan, Operational Plan
Johnson & JohnsonSenior Site Manager
Jun. 2009 - Feb. 2011Field-Based Senior Site Manger/Senior Clinical Research Associate: (Therapeutic Area: Phase 1:Pain and Phase II: Cardiovascular ).
• Assess potential investigators and decide on the suitability of the site.
• If required, conduct one or more pretrial visits to assess the investigational staff and facilities.
• Plan and conduct investigator and site-staff training.
• Develop/adapt recruitment and retention strategy for the site.
• Ensure that the current versions of the trial documents that are listed on the Site Initiation Report and all required trial-related materials and supplies are provided to the investigational site
• Ensure that the investigators send the SUA gap pack to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB.
• Set up the IF and TCF and ensure the IF is complete and accurate.
• Notify the GTM and the Local CSC in writing, when a country and an investigational site is approved to receive clinical drug supplies.
• At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored, and returned, accurately inventoried and documented.
• Follow up with the trial site regarding case report forms and data correction forms.
• Conduct monitoring visits, site closure according to the checklist of activities listed on the Monitoring Visit Report and the site closure report.
• Ensure that all AEs/SAEs/PQCs are reported within reporting timelines and documented as appropriate.
• Arrange for the appropriate destruction of clinical drug supplies.
• In studies where IVRS is used: Ensure that the IVRS at the site has been activated and tested and that unblinding capabilities are operational for those authorized to unblind subjects.
• Track costs at site level & ensure payments are made.
• Provide study report synopsis to investigators, IEC/IRBs.
• Follow up on and resolve any pending issues, including adverse events and IFDFs one year post-trial.
INC RESEARCHCLINICAL RESEARCH ASSOCIATE I (RICR)
Jul. 2007 - Jun. 2009Clinical Research Associate I: (Therapeutic Area: Oncology and Infectious Diseases)
• Site management and performance according to ICH guidelines, local regulations, as well as FDA regulations (state and local laws), GCPs, and SOPs. Site management activities include all in house and on-site monitoring for all visit types.
• Complete core clinical training program and develop independent monitoring skills.
• Site Selection including identification and feasibility
• Monitoring visits including pre-study, initiation, ongoing monitoring and close out as required.
• Arrange and Co-ordinate Annual CRA training days.
• Attend Investigator Meetings.
• Responsible for providing quality written documentation required for all clinical study documents (visit reports, correspondence, etc.) with a minimum of errors and guidance
• Understand importance of communicating problematic team issues to the Project manager and Line/Clinical manager for additional mentoring or resolution in a proactive manner
• Performs administrative duties, including attendance at clinical monitoring staff meetings, project team meetings, clinical committees, clinical training sessions, etc
• Maintains overall awareness in the field of clinical research, as well as assigned areas, by reading related literature, attending training classes, attending professional meetings, etc.
• Completing and collating documents for submission to Research Ethics Committees (IRAS) in accordance with specific guidelines. Ensures that the submission is done and that any issues resulting from these submissions are followed-up.
Merck SeronoClinical Trials Co-ordinator
Jan. 2007 - Jun. 2007Trainee CRA: (Therapeutic Area: Dermatology, Endocrinology, Paediatrics, and Reproductive Health)
• Maintain up to date information on ethics committee procedures and requirements in order to assist CTLs, Lead CRAs in study start-up.
• Liaise with CRA to obtain meeting dates and document requirements of EC committees.
• Act as central point of communication for extended implementation team, as well as study sites and central laboratory personnel.
• Ensure that payments processed in timely manner, track and provide ad hoc reports as requested to implementation team on payments related to: Investigators grants, Study Equipment, Central Laboratory, and Contract Research Organizations.
• Minute taking and appropriate frequency of distribution of minutes to allow management of actions between meetings.
• Accompanying CRA’s on monitoring visits. • In conjunction with the Clinical Trial Document Coordinator, set up and ensure TMF in compliance with GCP and Company SOPs.
• Liaise with CRAs to ensure timely deliver of CRFs to all study sites in time for patient visits on an ongoing basis and track.
• In conjunction with the Clinical Trials Document Management Coordinator, establish and maintain GCP archiving as appropriate.
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