Rasheed Badmus
Frederick,MD
Summary
Detail-oriented and highly organized Clinical Associate Project Manager with 13 years of experience leading clinical operations and managing complex, fast-paced protocols for sponsors such as Moderna and Gilead at a full-service CRO. Extensive background in oncology studies and team leadership, with a strong focus on timely, budget-conscious regulatory submissions. Demonstrated expertise in project management frameworks and clinical trial lifecycles, with a proven track record of overseeing more than 1,800 regulatory document submissions annually. Experienced in IND lifecycle management and well-versed in FDA and ICH regulatory guidelines. Also served as a Trial Master File (TMF) Associate, supporting clinical trial operations through the maintenance of inspection-ready TMFs. Proficient in document review, vendor oversight, and the generation of quality metrics to ensure TMF completeness and compliance.
Clinical operations professional with proven track record in managing complex healthcare projects and optimizing clinical workflows. Skilled in regulatory compliance, process improvement, and resource management. Known for fostering team collaboration and adapting to evolving needs, consistently delivering measurable results. Strong analytical skills, strategic thinking, and effective communication enable success in driving operational excellence.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Associate Clinical Operations Manager - Trial Master File
Technical Resources Internation
06.2023 - Current
- Ensure TMF completeness and accuracy in accordance with SOPs and global regulatory requirements.
- Maintain TMF throughout study lifecycle, including setup, ongoing document QC, and closure activities.
- Review a variety of clinical documents in short turnaround windows while ensuring consistency and quality standards.
- Review and align CRO-generated TMF document trackers with internal archival records to ensure accuracy and consistency.
- Evaluate site performance data to detect trends or issues and proactively escalate critical findings to management.
- Generate and analyze TMF metrics to support study teams in maintaining document quality and completeness.
- Participate in inspection readiness activities and contribute to TMF audits by preparing documentation and supporting records requests.
- Prioritize tasks to meet departmental and project-specific deadlines with minimal supervision.
- Provide training to TMF stakeholders on TMF best practices and system navigation.
- Assist in onboarding and mentoring new staff on TMF processes and tools.
- Support straightforward cross-functional projects involving process improvement or system enhancement initiatives.
Associate Clinical Operations Manager – Essential Regulatory Documents
Technical Resources Internation
06.2020 - 06.2023
- Assist in the management and coordination of clinical trial activities to ensure successful execution of study timelines and deliverables.
- Participate in vendor and CRO selection, oversight, and performance evaluation.
- Collaborate with cross-functional teams (e.g., Regulatory, Data Management, Safety, and Medical Affairs) to ensure seamless study execution.
- Review clinical trial data and reports to ensure quality and adherence to the protocol and regulatory requirements.
- Track study metrics (e.g., enrollment, site performance, monitoring visits) and help develop risk mitigation strategies.
- Track Study milestones (e.g., Study Start-Up / Study Initiation, Site Activation, Ongoing Trial Conduct, and Study Closeout).
- Support inspection readiness activities and contribute to audit preparation and responses.
- Participate in internal team meetings and contribute to process improvements and standard operating procedures (SOPs).
- Support the development and review of essential study documents, including protocols, case report forms (CRFs), informed consent forms (ICFs), and operational plans.
- Provide support in the onboarding and mentoring of new team members or junior staff.
- Plan resources and manage staff to ensure efficient operations and encourage development of capabilities. Oversee In-house Clinical Research Associates (CRAs) and calculates workloads using Full Time Equivalent (FTE) calculation; and conducts annual staff check and performance reviews.
In-House Clinical Research Associate III
Technical Resources Internation
07.2015 - 06.2017
- Guided and motivated In-house Clinical Research Associates (CRAs) to ensure the team fulfills responsibilities in accordance with sponsor requirements, Food and Drug Administration (FDA) regulations, ICH Good Clinical Practice (GCP) guidelines, and Technical Resources International’s (TRI) Standard Operating Procedures (SOPs) and Project Specific Procedures (PSPs).
- Trained In-house CRAs on current processes and serve as the team point of contact for questions and problem resolution.
- Responsible for the collection, review, tracking, and maintenance of essential regulatory documents (ERDs) during activation, supplemental, and close-out phases of clinical studies across more than 20 sites and over 50 protocols. Review ERDs for accuracy and completeness in accordance with FDA regulations, International Conference on Harmonisation (ICH)/GCP guidelines, sponsor requirements, and SOPs.
- Reviewed and approved In-house CRA responses to quality assurance audits to ensure issues are addressed appropriately and responses are submitted in a timely manner, in compliance with TRI or sponsor SOPs.
- Communicate findings and corrective action recommendations to investigators and study sponsors.
- Served as the primary liaison between clinical study staff, sponsors, and other stakeholders through both formal and informal communications, including updates, issue resolution, and information sharing.
In-House Clinical Research Associate I
Technical Resources Internation
08.2012 - 06.2015
- Review of Essential Regulatory Documents for completeness and accuracy.
- Manage and monitor project timetables and expectations.
- Assist in the development of project procedures, study-related documents (i.e., study binders, standard operating procedures, study guidelines, study management/tracking tools, e-mail/memorandum templates and checklists, project work specific instructions) and ensuring its successful implementation.
- Manage essential regulatory document collection, tracking, and transmittal using electronic systems, interfaces, and databases.
- Perform quality review assessment to ensure accuracy, completeness and compliance with the requirements and guidelines referenced in ICH GCP Guidelines, 45 CFR 46, 21 CFR 50, 21 CFR 312 and 21 CFR 812, Sponsor’s requirements and SOPs.
- Assist in generating project progress report and abstracting data from clinical trial systems to produce reports for internal and external personnel.
- Manage shipping and inventory of study supplies.
- Assisted In-house CRAs in accurately updating and maintaining clinical documents and systems (e.g., Trial Master File [TMF]) to track site compliance and performance within project timelines.
Education
B.S. - Biology
Morgan State University
01.2002
Skills
- Project Management
- Clinical Data Management
- Trial Master File
- Audit Preparation
- Review and Tracking of ERDs (Essential Regulatory Documents)
- GCP Training
- Onboarding and Coaching
- Quality Control
- Software: Adobe, Microsoft Office (Access, Word, Excel, PowerPoint, Outlook) WordPerfect, Oracle Clinical (RDC Onsite), Clinical Trials Management System, Veeva Vault, Medidata, TrackWise, Cardiff, Teleform (version 10), SPSS, SAS, Matlab, Medix, Unix, Linux, and NIH Clinical Research Information System (CRIS)
Certification
- CompTIA Security +CE (2018)
- Scrum Master Accredited Certification (2019) Public Trust Clearance (2018)
- Public Trust Clearance (2018)
AREAS OF EXPERTISE
- Project management
- Human and animal clinical research
- Trial Master File
- Relevant FDA regulations and ICH GCP guidelines
- Review of Essential Regulatory Documents
Timeline
Associate Clinical Operations Manager - Trial Master File
Technical Resources Internation
06.2023 - Current
Associate Clinical Operations Manager – Essential Regulatory Documents
Technical Resources Internation
06.2020 - 06.2023
In-House Clinical Research Associate III
Technical Resources Internation
07.2015 - 06.2017
In-House Clinical Research Associate I
Technical Resources Internation
08.2012 - 06.2015
B.S. - Biology
Morgan State University
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