Meghan MacDonald
I’m a clinical trial manager currently working to get new medications approved
- Role
- Senior Local Trial Manager, Johnson and Johnson Innovative Medicine at ICON plc
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Meghan MacDonald
I am an experienced clinical trial project manager currently supporting immunology. I\'m a…
Experience
Senior Local Trial Manager, Johnson and Johnson Innovative Medicine
May 2020 — Present · Raleigh-Durham-Chapel Hill, NC, US
Oversee clinical monitoring for studies within the US within the Neuroscience and Immunology therapeutic area • Collaborate with functional areas for country feasibility and site feasibility assessment • Ensure consistent conduct of pre-trial assessment visits and recommend suitable sites for selection to participate in trial • Maintain and update trial management systems. Use study tools and management reports available to analyze trial progress • Monitor country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicate study progress and issues to study management teams • Attend/participate in Investigator Meetings as needed • Manage the local team to meet recruitment targets Manage local vendors, as needed • Review and approve trip reports submitted by Site Managers (Clinical Research Associates) • Ensure clinical team training is rolled out and completed in a timely manner • Prepare for internal and external audits • Develop local study tools and procedures for sites and internal staff • Conduct proactive risk management and budget forecasting • Accompany Site Managers on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators • Act as an ambassador/mentor for ICON staff
Skills
- Ctms
- Clinical Trial Management System (Ctms)
- Pharmacovigilance
- Therapeutic Areas
- Report Development
- Healthcare
- Validation
- Microsoft Office
- Clinical Trials
- Market Research
- Conversational Spanish, Oral and Written
- Ich-Gcp
- Biotechnology
- Pharmaceutical Industry
- CRO Management
- Edc
- Clinical Monitoring
- Conversation
- Gcp
- Salesforce.com
- Microsoft Excel
- Sop
- Timeline, Budget and Vendor Management
- CRO
- Creativity
- Regulatory Requirements
- Electronic Data Capture (Edc)
- Client Presentation
- Content Development for Client Presentation and Creative Materials
- Clinical Research
- Project Management
- Medical Writing
- Diabetes
- Clinical Data Management
- Software Documentation
- Social Media
- Good Clinical Practice (Gcp)
- Protocol
- Fda
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