Megan Kirkwood
Conroe,TX
Summary
Megan Kirkwood is an experienced Clinical Research Professional with 19 years of experience in the clinical research industry. She is well versed with site feasibility, site selection, budget/contract negotiations, vendor management, study metrics tracking, development of monitoring plans and other study-related manuals/forms/tools, EDC, GCP/ICH, investigator meetings (preparation and presentation) and bid defenses. She also has experience with training and mentoring junior staff and identifying and resolving study site issues. She currently manages direct reports and is oversight manager and the escalation on multiple programs for Oncology and CNS.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Director, Project Managment
KCR
11.2022 - Current
- Oversees and manages clinical research studies within assigned project portfolio according to Project Management Plans, SOPs, GCP, ICH guidelines and local laws and regulations
- Staff line management responsibility within Trial Execution Services- Project Management
- Reviewed PM trainings for relevance and initiated a mentorship program for new and incoming PMs. Created a program for PMs with no CRA experience so they could be trained on CRA daily duties and expectations
- Oversight Manager on global CNS and Oncology trials
- Developed and implemented comprehensive strategies to improve operational processes and organizational efficiency.
- Recruited, trained, supervised, evaluated and mentored staff members.
- Conducted regular meetings with department heads to review progress on strategic initiatives.
Associate Director, Clinical Trial management- CNS Delivery Lead- Syneos Health (Acquired Synteract)
05.2022 - 11.2022
- Provides leadership, direction and management to Clinical Trial Managers (CTMs/Sr CTMs)
- Oversees the quality related to monitoring and site management activities to ensure clinical deliverables are met
- Acts as primary point of contact for monitoring strategy and alignment both internally and externally for assigned studies
- Used, metrics, dashboards and reports to analyze compliance and quality of services to ensure clinical operations/central monitoring delivery, manages escalated project and site related matters to drive follow-up action plans and improve departmental procedures
- Participated in the financial review of project status and drives project financial performance, particularly as related to clinical operations/central monitoring services
- Provided expert monitoring strategy, oversight and guidance to support internal teams and sponsors
- Guided internal teams and sponsors through and documents the key decisions needed to implement a high quality, efficient risk-based monitoring (RBM) solution
- Provided operational oversight and guidance to support prioritization of activities, reviewed and monitored the work performed, metrics compliance, and development of contingency plans, among others
- Oversaw progress of teams supporting clinical projects
- Ensured individual and team tasks were completed according to country/region specific and government regulations and per Sponsor/Customer expectations and contract
- Developed and supported customer relationships, managed customer expectations and escalated more serious risks and issues as required
- Line Management responsibilities included administrative oversight, professional development, performance appraisals, and mentoring/counseling of staff
Senior Clinical Trial Manager, Synteract- A Syneos Health Company
01.2021 - 05.2022
- Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
- Participated and presented in key meetings such as Kick Off Meeting
- Served as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members
- Accompanied CRA team members to sites for observation or conflict resolution
- Was Responsible for development and ongoing maintenance of clinical study tools and templates
- Oversaw resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identified risks to delivery or quality
- Oversaw CRAs and Central Monitors assigned to the study and routinely assessed study-specific process and training compliance, CMP compliance, and identified emerging risks
Global Clinical Team Manager, PRA Health Sciences
05.2020 - 01.2021
- Participated in Investigator meetings, assisted with presentations as needed
- Liaised with Clinical Operations Managers to resolve resource and performance issues
- Reviewed Essential Documents to ensure sponsor and investigator obligations were being met and were in compliance with applicable local regulatory requirements and ICH guidelines Interacted with client(s), vendors and PRA functional areas as primary project contact for clinical issues, Mentored junior level staff
- Provided timely status reports for the clinical activities on assigned projects Contributes to Business Development Activities participated in proposals and bid defenses as needed and Led the clinical operations team on projects, providing study specific and therapeutic training and mentoring as required
- Experience in managing all trial components (Start-up to database lock)
- CTM lead on a global hematology oncology/ rare disease trial.
Clinical Trial Manager, Synteract
05.2019 - 05.2020
- Managed Phase II-IV Dermatology, Rare Disease, and Oncology Clinical Trials
- Served as the primary clinical contact for both the client and Synteract project team members
- Coordinated, facilitated, and conducted training for clinical study teams as required and addresses ongoing training needs throughout the study
- Oversaw site assignments and ensured clinical resources were continuously adequate
- Participated in external study meetings, including both client and investigator meetings
- Developed and maintained clinical study documents, templates, plans and manuals
- Oversaw the set-up and maintenance of the clinical portion of the Trial Master File
- Tracks and reviews Monitoring Visit Reports and ensures standards for monitoring and reporting are met
- Supported Business Development in preparing for and attending Bid Defense Meetings; was approached for multiple bid defense meetings due to presentation and preparation skills
- Conducted monitoring visits (PSVs, IMVs, COVs) and attended accompanied field assessment visits with CRAs as appropriate
- Participated in an initiative to update the dermatology program templates
- Provided support and leadership to new Clinical Trial Managers by participating in the mentorship program.
Clinical Trial Manager, Mckesson/ MCRO
09.2015 - 04.2019
- Primary contact for sponsors/CRO and vendors
- Recommended leads and implemented tactical process improvements
- Contributed to a culture of process improvement, performance measures, project prioritization, and developing successful solutions and provides clear direction with timelines for supporting members of the project (budget, contracts, regulatory, pricing, network operations, others)
- Managed Phase II-IV clinical trials including Investigator Initiated trials
- Assisted with site selection and selecting appropriate sites for the client
- Reviewed/ approved CRFs for the network CTMS and EDC system (CRO and Investigator Initiated trials)
- Participated in two fiscal year initiatives: Site Activation and Improved Feasibility.
Owner/Director, Medical Development Centers, LLC
04.2009 - 08.2016
- Owned and managed a clinical research Site Management Organization
- Responsible for business development by recruiting new investigators and finding leads on clinical trials to grow the pipeline
- Completed quality assurance for essential documents and subject records
- Maintained and updated company SOPs
- Managed a team of 10+ study coordinators and study nurses
- Managed clinical trials in multiple indications including, but not limited to: Gastroenterology, Women’s Health, Dermatology, Infectious disease, Cardiology, Endocrinology, Pulmonology, Ophthalmology, Neurology.
Site Manager
Gulf Coast Research
Baton Rouge, LA
09.2008 - 12.2010
- Managed 20+ employees for a Site Management Organization in Baton Rouge, Opelousas, and Lafayette Louisiana
- Established a quality assurance program using a “No stickies” method of reviewing source documents prior to monitoring visits and audits
- Developed source document templates and other study related tools
- Completed feasibility assessments for potential studies and completed the study start-up process
- Responsible for maintaining the Trial Master Files
- Developed a training program for study staff.
Research Coordinator
Gulf Coast Research
09.2004 - 09.2008
- Facilitated and coordinated the daily clinical trial activities
- Managed clinical trials in multiple indications including, but not limited to: Gastroenterology, Women’s Health, Dermatology, Infectious disease, Cardiology, Endocrinology, Pulmonology, Ophthalmology.
Education
Master of Science - Clinical Research Administration
Walden University
03.2018
Bachelor of Business Administration -
Southeastern Louisiana University
05.2010
Skills
- Staff Development
- Program Management
- Project Management
- Operations Management
- Training Methods
- Team Leadership, Training, And Development
- Business Administration
- Performance Feedback
- Strategies And Goals
Certification
- 09/2008, Certified Clinical Research Coordinator, ACRP
- 10/2009, Certified Clinical Research Associate, ACRP
Delivery Lead Oversight Experience
- 1 program, 2 protocols: Parkinson’s Disease and Multiple System Atrophy
- 1 Program, Phase I Solid Tumor
- 1 Program, 7 Protocols: Migraine (Pediatric and Adult- Acute and Chronic)
- 1 Program, 3 Protocols: Sleep Disorder- Sleep Apnea
- 1 Protocol: Atopic Dermatitis (Pediatric and Adult)
- 1 Protocol: Solid Tumor
- 1 Protocol: Sickle Cell
Timeline
Director, Project Managment
KCR
11.2022 - Current
Associate Director, Clinical Trial management- CNS Delivery Lead- Syneos Health (Acquired Synteract)
05.2022 - 11.2022
Senior Clinical Trial Manager, Synteract- A Syneos Health Company
01.2021 - 05.2022
Global Clinical Team Manager, PRA Health Sciences
05.2020 - 01.2021
Clinical Trial Manager, Synteract
05.2019 - 05.2020
Clinical Trial Manager, Mckesson/ MCRO
09.2015 - 04.2019
Owner/Director, Medical Development Centers, LLC
04.2009 - 08.2016
Site Manager
Gulf Coast Research
09.2008 - 12.2010
Research Coordinator
Gulf Coast Research
09.2004 - 09.2008
Master of Science - Clinical Research Administration
Walden University
Bachelor of Business Administration -
Southeastern Louisiana University
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