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Work Background
IQVIASenior Project Manager
Mar. 2024City of Cape Town, Western Cape, South AfricaResponsible for all activities related to implementation of clinical studies including: • Manages projects of full scope regional and global projects. Responsible for project team leadership • Responsible for building and maintaining positive client relationships • Ability to negotiate with clients to assure IQVIA Biotech’s operational processes are maintained, projects are done within scope. • Reviewing and identifying project study trends and proactively responding to client and respective team members • Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges • Responsible for change management on all assigned projects • Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead • Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware • In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms. • Oversee delegation of support staff activities, as necessary • Assists in the development and delivery of capability and proposal defense presentations to prospective clients • Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team. • Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually • Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
IQVIA BiotechShadow Board Member
May. 2023 - Apr. 2024
IQVIAProject Manager
Jul. 2022 - Mar. 2024Cape Town, Western Cape, South Africa
IQVIAClinical Operations Specialist
May. 2021 - Jul. 2022South AfricaManage clinical vendors (including on-site monitors / CRO) and oversee relevant sections of the Protocol Management Plan. Management and oversight includes, but is not limited to the following activities: 1. Lead point of contact for clinical vendors 2. Support vendor selection and contracting 3. Train vendors 4. Monitor vendor performance against contract, ICH GCP, relevant SOPs, local Regulatory and ethical standards and protocol; includes site visit report review and quality oversight visits 5. Track vendor invoices for accuracy and against contract, send invoices for processing and payment. • Provide initial and ongoing training to other departments and site staff to support the conduct of clinical trial activities. • Conduct risk planning and mitigation for vendors and clinical activities and work with CTM to mitigate risks and solve issues. • Review, provide input and draft assigned sections of key study documents. • Ensure approved monitoring plan is in place. • Develop quality oversight plan for monitoring activities. • Assist CTM in establishing study timelines and budgets for clinical aspects of trials and ensure clinical activities are conducted within timelines and budget. • Manage and oversee the completeness and accuracy of the Trial Master File (TMF) through appropriate reviews of all study related information, ensuring TMF is inspection ready. • Work with CTM and other departments to oversee data quality through various means including data listings reviews. • Prepare for and conduct site visits as needed, including site qualification, study initiation, interim monitoring, and close-out visits. • Provide study status updates to project team and management as needed. • Act as clinical operational lead on observational studies as assigned.
IQVIAFunctional Resourcing, Manager
Apr. 2021 - Jul. 2022Cape Town, Western Cape, South AfricaResponsible for line management support of assigned IQVIA CRAs. Responsibilities of the DLMs include conduct of interview/hiring activities, assessing ongoing performance of staff, completing/administering performance appraisals, goal setting/review for direct reports, facilitating professional/career development of staff, administrative oversight activities (expense report review, time coding review, vacation approvals), ensuring staff compliance with required IQVIA training/SOPs, and administering disciplinary action when appropriate.
PPDSite visit accompanier
Sep. 2020 - Apr. 2021- Accompany CRA's/monitors on routine site visits to ensure adequate standard of monitoring skills - Perform routine monitoring assessment visits - Perform authorization visits for junior CRA's or CRA's that are new to the company
PPDSenior Clinical Research Associate
Feb. 2020 - Apr. 2021Cape Town, Western Cape, South Africa- Mentor and guide more junior CRA's - Ensure compliance with site contracts and site payments to be made on-time - Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. - May be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. - Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. - Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. - Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. - Build awareness of features and opportunities of study to site. - Collaborate and liaise with study team members for project execution support as appropriate.
IQVIAClinical Research Associate 2
Jun. 2019 - Feb. 2020Amsterdam Area, Netherlands
IQVIAClinical Research Associate 1
May. 2017 - Jul. 2018Cape Town Area, South Africa Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. Build awareness of features and opportunities of study to site. Collaborate and liaise with study team members for project execution support as appropriate.
IQVIAClinical Research Associate Trainee
May. 2016 - May. 2017Cape Town Area, South Africa
University of Cape TownPBL Facilitator
Jul. 2014 - Apr. 2016Cape Town Area, South AfricaFacilitate small group discussions (8 - 10) students, between MBChB students at UCT. PBL (problem based learning) is based on a biopsychosocial approach the medical teaching, engaging the students on a biological, psychological and social level.
University of Cape TownPart-time Lecturer
Jun. 2014 - Apr. 2016Cape Town Area, South AfricaLecturing embryology to first and second year MBChB students
University of Cape TownDemonstrator
Jan. 2014 - Apr. 2016Cape Town Area, South AfricaDemonstrating anatomy for the 1st and 2nd year MBChB students. Doing a research Masters in anatomy at the University of Cape Town.
University of Cape TownSecratary
Jan. 2014 - Apr. 2016Cape Town Area, South AfricaSecretary as part of the Journal Club Committee for the Journal Club of the Department of Human Biology for Anatomy and Anthropology.
University of the Free StateDemonstrator
Jan. 2013 - Dec. 2013Bloemfontein Area, South AfricaI am a honours student majoring in Anatomy. As part of my course I help assist at anatomy practicals for the first year MBChB, nursing, physiotherapy and occupational therapy students. I do dissection on the kadawers, and I am currently writing 4 literature reviews and 1 protocol for my B.Med degree.
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