James McLoughlin
Wilmington
Summary
Senior Project Manager with 13 years of Clinical Research experience and over 12 years in project leadership. Expertise in managing global studies across Phases 1-4 in various therapeutic areas, ensuring adherence to ICH-GCP standards. Proven track record of delivering projects ahead of schedule, achieving early database locks, and meeting recruitment goals. Strong focus on team collaboration and accountability, fostering a culture of recognition and support among team members.
Overview
13
13
years of professional experience
Work History
Sr. Global Project Manager
The Emmes Company
01.2024 - 01.2025
- Served as primary contact for sponsors, consistently exceeding deliverable targets across projects.
- Delivered three interim data cutoffs ahead of schedule, meeting timelines for two DSMB meetings.
- Managed teams to outperform accelerated startup schedules for two studies through effective leadership.
- Analyzed diverse data sources to generate insights on project status and performance trends.
- Created study budgets, negotiated vendor contracts, and optimized forecasting tools and accruals.
- Developed real-time tracking tools to monitor project deliverables against targeted timelines.
- Mentored team members to enhance collaboration among international offices.
- Ensured compliance with quality standards during management of global projects.
Sr. Project Manager
Fortrea
01.2022 - 01.2024
- Achieved on-time database locks for all assigned studies, including two early recruitment milestones and three early database cuts.
- Managed project delivery, ensuring alignment with timelines, scope, cost, and quality across functional groups and vendors.
- Met financial performance targets while developing transparent reporting and forecasting methods.
- Proactively managed changes in project scope, timelines, and processes through effective action initiatives.
- Created comprehensive project plans and site-specific guides for protocol amendments and recruitment strategies.
- Developed tools and metrics to monitor study progress in real time, addressing risks collaboratively with the project team and sponsor.
- Assigned project resources, provided training, and established succession plans for critical roles.
- Presented tailored delivery strategies during meetings to attract prospective sponsors and secure new project awards.
Sr. Global Project Manager
Syneos Health
01.2020 - 01.2022
- Directed all functional areas while sustaining positivity by reinforcing accountability for deliverables and timelines among all leads
- Facilitated assigned teams in achieving recruiting objectives ahead of time for 4 studies, utilizing fresh approaches that encouraged constructive site rivalry and enhanced motivation through unique appreciation of recruitment accomplishments for sites.
- Enhanced study advancement by implementing diverse tracking instruments and novel strategies, later adopted by other project teams for financial forecasting and patient recruitment projections.
- Crafted and preserved project plans for study per SOPs and Work Instructions (WI), generating new Project Plans to address particular study aims.
- Conducted continuous review and reporting of project financial status including financial forecasts to Sponsors and internal Executive Group.
- Collaborated with functional groups to execute inspection readiness checks throughout all assigned projects.
Project Manager II
Syneos Health
01.2017 - 01.2020
- Oversaw and directed all functions and responsibilities of Sr. Project Manager role, ensuring successful project execution, and client satisfaction.
- Collaborated with senior team members for mentorship, enhancing project management skills and knowledge.
- Executed timely project deliveries, reaching key milestones and surpassing client expectations.
- Guided assigned staff as mentor and Line Manager, facilitating 4 promotions for direct reports
- Managed vendor oversight encompassing contract negotiation, timelines, and deliverables.
Project Manager I
Syneos Health
01.2015 - 01.2017
- Directed and oversaw all functions and responsibilities of Project Manager II role, ensuring successful project execution and client satisfaction, achieving critical milestones ahead of schedule.
- Engaged with senior team members for mentorship, advancing project management skills and knowledge, resulting in elevated team performance and project outcomes.
- Finalized projects before deadlines, outpacing client expectations and accomplishing key milestones.
Associate Project Manager
Syneos Health
01.2014 - 01.2015
- Conducted comprehensive duties of Project Manager I role while collaborating with supervising Project Manager for support and mentorship throughout study initiation phase.
- Assumed Project Lead responsibilities, serving as main sponsor contact and directing all functional teams after supervisory period concluded.
- Executed comprehensive financial reporting, revenue accounting, and forecasting for presentation to internal executive team and Sponsor
- Oversaw creation and management of timelines for all deliverables and milestones for assigned studies.
CRA
Syneos Health
01.2013 - 01.2014
- Facilitated operational execution of clinical trials at study sites, ensuring compliance with regulatory standards and effective management of site partnerships for strategic milestone achievement.
- Collected and reviewed site essential documents, created study files, and managed regulatory submissions, ensuring data quality and integrity.
- Analyzed and confirmed data sourced from electronic data capture (EDC) systems, detecting and addressing data discrepancies, and generating reports on study progress and site performance.
- Functioned as primary site contact for all site inquiries and challenges.
- Contacted sites to resolve open data queries, missing documents, and action items.
Project Specialist
Syneos Health
01.2012 - 01.2013
- Implemented and managed tracking tools, confirming projects consistently met deliverables, action items, patient recruitment, and site performance.
- Administered regular status reports of eTMF completion and quality, liaising with team members to resolve outstanding documents or quality issues, advancing document quality by over 40%
- Coordinated development and structuring of study plans and timelines, guaranteeing effective communication with project teams and stakeholders, resulting in on-time project delivery and enhanced stakeholder satisfaction.
- Achieved 100% on-time training accuracy by meticulously tracking training requirements for project team members.
Managed onboarding and training assignments for new team members during transitions. - Documented precise meeting minutes and action items for all internal and external project meetings.
Education
Bachelor of Arts - Business Administration and Management
Providence College
Provdence, RI05-2005
Skills
- Project management and leadership
- Clinical trial management systems
- Project planning and development
- Team collaboration and building
- Data verification and management
- Microsoft Office proficiency
- Interactive response technology
- Agile project tracking (Jira)
- Regulatory compliance (ICH-GCP)
- Project management office oversight
- Vendor selection and management
- Direct report supervision
- Timeline and status reporting
- Effective communication skills
- Electronic data capture expertise
- Regulatory submissions for study/site start-up
- Problem-solving strategies
- Veeva Vault proficiency
- Site contract negotiation and management
- Query resolution management
- Protocol deviation oversight
- Proposal development and presentation
- Site management and monitoring
- Bid defense presentations expertise
- Clinical monitoring and source data verification
- Budget forecasting and development
- Mentoring team members
- Change management
- Complex Problem-solving
- Organizational skills
- Work Breakdown Structures
Accomplishments
Clinical Researcher of the Year, 2019-Team Based Competition
Timeline
Sr. Global Project Manager
The Emmes Company
01.2024 - 01.2025
Sr. Project Manager
Fortrea
01.2022 - 01.2024
Sr. Global Project Manager
Syneos Health
01.2020 - 01.2022
Project Manager II
Syneos Health
01.2017 - 01.2020
Project Manager I
Syneos Health
01.2015 - 01.2017
Associate Project Manager
Syneos Health
01.2014 - 01.2015
CRA
Syneos Health
01.2013 - 01.2014
Project Specialist
Syneos Health
01.2012 - 01.2013
Bachelor of Arts - Business Administration and Management
Providence College
Similar Profiles
Phyllis Zaia AldermanPhyllis Zaia Alderman
Senior Project Leader at The Emmes CompanySenior Project Leader at The Emmes Company
Shola OgbodoShola Ogbodo
Clinical Data Manager at The Emmes CompanyClinical Data Manager at The Emmes Company
Carolyn BurkeCarolyn Burke
Associate Director, Clinical Study Management at The Emmes CompanyAssociate Director, Clinical Study Management at The Emmes Company
Indie PurdueIndie Purdue
Busser, Food Runner, and Host at Jailhouse ProvisionsBusser, Food Runner, and Host at Jailhouse Provisions
ERICKA JOHNSONERICKA JOHNSON
Insurance Claims Representative at ModivCareInsurance Claims Representative at ModivCare