Senior Clinical Research Associate (contracted) / Clinical Project manager / Consultant at SELF EMPLOYED/FREELANCER
Director Program Clinical Delivery lead (PCDL), Fertility, Endocrinology, CMC, N&I and General Medicine at MERCK PTY LTD (2021-04 – 2024-05)
Direct Reports: 29 Clinical Research Managers, 1 Clinical Trial Leader, Global Project Managers - dotted line, Cross functional on a program Level (Global Data Management Lead, Clinical Quality Management, Patient Safety, 4 x Strategy Leads, Medical Writers, CRO's, Clinical Leads).
Regions responsible for: UK, USA, Europe, Japan, China, Australia, South Africa and Africa. End to end operational oversight of all company sponsored phase II- IV, collaborative research studies and investigator sponsored studies.
- Provision of leadership and strategic direction as operational delivery SME
- Program and study level issue and trend identification and mitigation
- Provision of proactive risk based and quality risk oversight and management
- Provision of risk-based sponsor oversight for investigator sites
- Facilitation of robust start up, monitoring and oversight activities
- Acting as operational lead for early access programs
- Representation at various governance boards (review and approval of phase IV company sponsored studies and investigator sponsored studies)
Compound Operations lead (COL) N&I at MERCK PTY LTD (2023-11 – 2024-05)
Additional assigned role.
- Responsible and accountable for the strategic operational planning and strategic cross functional collaborations
- Accountable for the oversight of day-to-day activities of all aspects for the management of global/regional company sponsored studies, including study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
- Accountable for the oversight of large scale, strategic company sponsored late phase studies and investigator sponsored studies, granted by Merck PTY Ltd, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according to approved plan, managing product supply, if applicable and coordinating internal review of final report
- Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
- Oversight of the development and monitoring of study budgets and timelines
- Oversight of work of cross-functional teams to ensure quality of study-related deliverables
- Contribute to the planning and set-up of studies and provide planning parameters
Associate Director, Regional Clinical Research Manager, Clinical Operations Lead (Global Health) at MERCK PTY LTD (2019-08 – 2021-02)
Operational lead for the International Pediatric Praziquantel consortium. Responsible and accountable for the strategic operational planning and strategic cross functional collaborations across the assigned programs. Accountable for the oversight of day-to-day activities of all aspects for the management of global/regional company sponsored studies.
- Accountable for the oversight of large scale, strategic company sponsored late phase studies and investigator sponsored studies, granted by Merck PTY Ltd, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according to approved plan, managing product supply, if applicable, coordinating internal review of final report
- Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
- Oversight of the development and monitoring of study budgets and timelines
- Oversight of work of cross-functional teams to ensure quality of study-related deliverables
- Ensures that trial status is tracked and entered the respective Clinical Trial Management System
- Contribute to the planning and set-up of studies and provide planning parameters
Site Relationship and Operation Lead (SROL)/Clinical Research Manager (CRM) at MERCK PTY LTD (2013-07 – 2019-08)
Interaction with various regulatory stake holders from Southeast African and SADC member countries as well as Ivory Coast and Cameroon. Interaction with NEPAD agency on ad hoc basis concerning clinical trials. Regulatory strategy planning and implementation regarding clinical trials. Reason for leaving: Retrenched.
- Compilation and maintenance of regulatory fact sheets for Southeast Africa, and parts of West Africa
- Information source on pharmacovigilance requirements in Southeast African countries
- Review and approval of CTA dossiers prior to regulatory submissions
- Sponsor-Regulator relationship building and maintenance in SEA
- Hosting and presenting at Scientific and Regulatory workshops on neglected tropical diseases
- Clinical operations and trial lead for global NCE development program
- Liaison between the company and investigational sites building investigator and site staff awareness on Merck PTY Ltd
- Conduct of accompanied visits with CRA's to determine skills gaps
- SME for allocated studies
- Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
- Act as Legal Line Manager for Clinical Account Managers, Clinical Research Managers and Senior Clinical Research Managers, as needed
- Providing leadership and guidance in operational activities at product level, drive performance across studies in regards of timelines, cost and quality, by guiding CRM activities strategically per product to identify gaps in deliverables and ensuring product level mitigation plans are implemented and results in improvement
Snr Clinical Research Associate (Level II) at PPD (2010-12 – 2013-06)
Responsible for 106 investigative sites across 11 countries, with 29 CRAs in EMEA indirectly reporting. Lead CRA for 2 double blind protocols and back up Lead for 1 open label extension protocol.
- Site identification and conduct of feasibilities, site selection, site initiation and investigator meeting coordination and presentation
- Responsible for study visit report reviews, review of study issues and following to resolution, identifying and mitigating risks on the projects
- Reviewing and updating site visit report annotations and monitoring plans
- Creation of master essential document lists required to be maintained in study files
- Consolidating investigator payments
- Review of study specific training to ensure all sites and CRAs have completed all required training
- Delivery of key milestones to clients within budget across the region
- Reporting to CTM and PM on study deliverables
- Hosting client audits and regulatory inspections
- Chairing of study team calls
- Review and maintenance of CTMS across the region
- Identification of training gaps, and escalation of these training gaps
- Mentoring and coaching of junior staff
- Co monitoring with junior staff were indicated
- Conducting routine performance visits to evaluate peers
