SUMMARY

• Committed Project Manager with over 12+ years of clinical research experience, including 8+ years of Contract Research Organization (CRO) experience serving on global studies, and 1 year of consultancy service. Multi - dimensional professional that focuses on tracking project results, milestone attainments, and implementing performance improvement strategies.
• Adept at developing, executing, and managing global clinical studies (Phases I-IV) within the therapeutic areas of Central Nervous System (CNS), Psychiatry, Oncology, and Pain Management.
• Proficient in ensuring that all study initiatives align with research and project goals. Led project and process development from inception to completion.
• Valued professional recognized for exemplary customer service, communication skills, ability to work well both independently and in matrix environments.

PROFESSIONAL EXPERIENCE

Confidential, Irvine, CA

Sr. TMF Process/Sr. Business Analyst

Responsibilities:

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• Leads cross-functional efforts toward standardizing processes and maintaining compliance.
• Liaise with stakeholders and study team members to secure artifacts (ex: Site Essential Documents, confidentiality agreements, master service agreements, clinical trial agreements as appropriate, etc.) and prioritize sites for IP Release approval.
• Responsible for Quality Control of both standard and complex TMF content.
• Participates as a study team member and collaborates with functional SMEs to address consistent quality gaps.
• Triages system issues, escalates as needed, and implements system upgrades.

Confidential

Project Manager

Responsibilities:

• Identified appropriate resources for each task through collaboration with functional representatives.
• Created and manages project artifacts during all phases of the project. (Charter, project plan, etc.)
• Facilitated project discussions to ensure progress and identify appropriate team actions or risks.
• Ensured project tasks are completed and necessary action plans are executed on the ensure project progress.
• Met project objectives through the management of scheduling conflicts, resource constraints, and financial forecasting.
• Tracked project deliverables through appropriate tools and framework; while reporting to all stakeholders.

Confidential

Project Manager

Responsibilities:

• Managed the scope of work, timelines, budget expectations, and the research conduct of 4 clinical studies.
• Assessed and verified adherence to project actual versus forecast study metrics.
• Prepared the Project Plan (including timelines and communication plan) and implemented alternative solutions to problems with study timelines, schedules, resources, budgets, and enrollment. z
• Determined resources, priorities, managed direct reports, and verified completion of all tasks per timelines.
• Trained clinical investigators and support staff on clinical protocols and database functionality.

Confidential, Atlanta, GA

Regulatory Compliance Manager

Responsibilities:

• Oversaw and managed direct reports; while organizing and executing Phases I - IV regulatory submissions.
• Maintained internal regulatory databases and interfaced with external databases.
• Provided Quality Assurance reviews of the clinical development of regulatory documents per benchmarks.
• Defined staff development goals and performance metrics.

Confidential, Marietta, GA

Project Manager

Responsibilities:

• Updated global research teams on project progress and other relevant issues.
• Oversaw the execution of data cleaning activities and timelines.
• Reviewed project progress and adjusted project timelines accordingly.
• Tracked actual performance against planned project performance, minutely analyze all variances, and maintained project control.
• Provided written and verbal status reports to upper management regarding the status of assigned projects.

Confidential, Henderson, NV

Clinical Research Associate

Responsibilities:

• Queried data inconsistencies and revised CRFs in compliance with Standard Operating Procedures (SOPs).
• Conducted Pre-Study Site Qualification, Site Initiation, Interim, and Close-Out monitoring visits.
• Reviewed trial documents (including: 1572s, Delegation of Authority Logs, regulatory submissions, Informed Consent Forms, patient study materials, AE, and SAE reports, etc.).
• Performed site management duties, including patient recruitment strategies and medical query resolution.
• Managed trip reports, site correspondence letters, query resolutions, and expense reports.
• Remained current on internal procedures, processes, and applicable agency regulations.
• Provided comprehensive support to clinical trial teams, project managers, and clinical team managers during initiation, maintenance, and close-out of clinical projects.

Confidential, Bridgewater, NJ

Quality Control

Responsibilities:

• Assisted team members during QC process by identifying missing, incomplete, and misplaced source documentation.
• Evaluated the quality status of a project by reviewing applicable project quality metrics.
• Maintained and organized clinical trial central files according to quality expectations.

Confidential

Science Editorial Project Manager

Responsibilities:

• Created project work plans and adjusted timelines to meet shifting priorities and demands.
• Managed vendors, assigned developmental projects and processed payment upon completion of assignments.
• Effectively communicated, prepared, and managed vendor manuscript submissions, and assured that forecast deadlines were achieved.
• Prepared and presented program presentation materials for both internal and national program meetings.