Mark Self
Lubbock,TX
Summary
Highly competent and experienced Manager of Clinical Operations and formerly a Clinical Project Associate with years of experience in providing results for employers and clients. Skilled in leading employees and managing resources to meet client needs and expectations. Creates a positive and professional work environment that attracts and retains top talent, delivering services that exceed customer expectations. Proficient in regulations and good practices governing clinical trials and new pharmaceutical products, including company operating procedures, Code of Federal Regulations, and ICH/GCP guidelines. Experienced in electronic Trial Master File (eTMF) filing and review of study-related documents throughout the trial process. Consults with various stakeholders, including trial sites, sponsors, and internal trial personnel. Familiar with study-related documents requiring IRB review, such as protocol amendments, continuing reviews, and protocol deviations/exceptions. Offering proven leadership skills and a solid foundation in clinical research. Eager to learn and develop in clinical operations while focusing on regulatory compliance and process improvement.
Overview
15
15
years of professional experience
Work History
Manager of Clinical Operations
ICON Strategic Solutions
09.2020 - 01.2025
- Managed 16 to 18 team members by following key principles regarding resourcing, people leadership, training, functional delivery, quality and operational delivery at a regional and/or country level. This included oversight of productivity and quality metrics, timely and objective performance reviews, recommendations for promotions and utilization of measurement systems
- Used the key principles of client project management at the functional level to ensure staff assignments were suitable to meet utilization and productivity targets
- Used key performance metrics and ensured delivery of them by staff to meet performance objectives for productivity and quality and take appropriate remedial actions and/or escalations as required
- Performed role in Inspection Readiness processes and educated team members on its importance.
- Served as a contact regarding operational questions and escalations.
- Interviewed, evaluated and selected new associates and ensured induction and orientation of newly hired team members
- Established a trusting and open two-way communication path to provide and receive timely and relevant updates to staff members
- Partnered with team members on their development, identified opportunities to progress in line with their career aspirations and helped them get visibility inside and outside the department
- Implemented measures for retention of staff as needed
- Understood the drivers of revenue and cost for the department and contributed to budgeting discussions to ensure profitability
- Provided feedback on the development and implementation of formal training tools and presentations
- Assisted with review of current processes and implementation of agreed process improvements in collaboration with other regions and/or departments and communicated changes and innovations effectively to team members.
In-House CRA III
PRA Health Sciences
05.2016 - 09.2020
- Served as a primary liaison for site start-up and in-house site management issues, escalating to the Project Manager (PM) as required
- Supported PM in managing sites to ensure compliance with study timelines, trial protocols, ICH/GCP guidelines and regulatory requirements
- Achieved successful delivery of site start-up, in-house site management and close-out activities meeting internal and external client requirements
- Performed essential document distribution, collection, and review for study start-up, maintenance, and close-out activities
- Determined, tracked, and reviewed milestones, tasks, and timelines for all clinical activities for assigned projects and provided timely status reports for clinical activities
- Performed study tracking via designated systems ensuring study files were current, accurate and complete
- Interacted with sites, clients, vendors, and internal functional areas as a secondary project contact for site issues and questions
- Assisted with Investigational Product accountability, subject screening/enrollment, Case Report Form retrieval and query distribution to/from investigational sites
- Consulted with internal and external customers to meet project specific goals including participation in sponsor and project related meetings
- Lead other colleagues on projects, providing training and mentoring as required
Project Specialist II
INC Research
02.2014 - 05.2016
- Supported PMs in ensuring the quality and delivery of clinical trials
- Assisted PMs with the management and maintenance of the trial
- Operational lead for the organization, compilation, and transfer of electronic TMFs for three related studies
- Supervised and directed a team in reviewing TMF for accuracy and completeness
- Oversaw TMF document submission according to quality guidelines and TMF structure
- Prepared and delivered detailed reports on the performance and conduct of clinical trials
- Involved collection and analysis of trial information then presenting information to trial stakeholders
- Organized, performed, and maintained a clinical recruitment initiative
- Involved regular contact with trial sites, collection and analysis of subject recruitment information, and management of financial payments to sites for performance
- Tracked and analyzed project details and maintained internal systems for assigned projects within a therapeutic area
- Assured compliance with local regulations, regulatory and GCP guidelines, and company operating procedures
- Served as a liaison for other study personnel including external and internal customers
- Maintained project communications including meeting schedules, minutes, and any other mass communications
- Processed and tracked financial details for invoicing and study expenses
Clinical Project Support Specialist
Quintiles
10.2009 - 02.2014
- Operational lead for the organization, compilation, and transfer of the eTMF for a study
- Supervised a team of people in the maintenance of the eTMF for the trial by updating filing structure, adding documents, and periodic review of study files for accuracy and completeness
- Functioned as a central liaison with the sponsor regarding the eTMF
- Functioned as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
- Assisted PMs and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
- Assisted the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Assisted PMs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
- Assisted with the tracking and management of Case Report Forms, queries, and clinical data flow
- Performed assigned administrative tasks to support team members with clinical trial execution
Education
B.A. - Government
University of Texas
Austin, TX05.2002
Skills
- Clinical trial management
- Staff management
- Employee performance evaluations
- Documentation management and reporting
- Highly skilled with Microsoft office including Word and Excel
- Computer skills including Teams, OneNote, Veeva Vault, CTMS systems
- Multitasking and organization
- Exemplary communication skills
- Detail-oriented
- Very comfortable and collaborative in virtual office environments
- eTMF Review and auditing
- Regulatory submissions
Accomplishments
- Supervised team of 16 to 18 staff members to meet and exceed client expectations.
- Managed and tracked compliance with study deliverables for all staff members.
- Used Microsoft Excel including data analysis and pivot tables to track compliance with study deliverables and client expectations.
- Documented and resolved issues with eTMF which led to timely compliance with study deliverables.
- Participated in resourcing staff and in interviewing new hires.
Affiliations
Regulatory Affairs Professional Society, RAC Certification, 2006-2012
Further Information
References and therapeutic experience are available on request.
Timeline
Manager of Clinical Operations
ICON Strategic Solutions
09.2020 - 01.2025
In-House CRA III
PRA Health Sciences
05.2016 - 09.2020
Project Specialist II
INC Research
02.2014 - 05.2016
Clinical Project Support Specialist
Quintiles
10.2009 - 02.2014
B.A. - Government
University of Texas
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