Sheri Friends
Chesterfield
Summary
Goal-oriented and self-motivated professional with excellent communication and interpersonal skills. Proven ability to lead cross-functional teams and manage complex projects. Strong background in clinical trial support, document management, and regulatory compliance. Adept at driving process improvements and ensuring high-quality deliverables.
Overview
28
28
years of professional experience
Work History
Director, Global CT Documents Submissions and eTMF Operations Lead
Bristol-Myers Squibb Company
2022 - Current
- Provide leadership, strategic direction, and management oversight a large team of Clinical Trial Support Specialists, eTMF Operations and Central Upload team to ensure processes and related documentation are of the highest quality for active in-house and outsourced studies
- Work closely with other TMF Process Leads to ensure the end-to-end process for document management and archival in the TMF is of high quality and in line with industry standards. Attend and represent eTMF Operations at key meetings
- Actively engage with leadership from business case development through program delivery, ensuring organizational alignment on scope, schedule, quality, benefits, and implementing and monitoring appropriate controls to proactively deal with barriers to completion
- Participate and lead benchmarking initiatives with peers externally to stay abreast of new ways of working and evolving technologies
- Maintain global processes, procedures, and training materials to ensure CTSS and eTMF activities remain in compliance with ICH GCP requirements, BMS Global Quality Standards, and ALCOA-CCEA principles
- Support development and governance of global TMF processes by close cooperation with relevant functions and Local Process Leads
- Manage the development and finalization of GDO protocol-related submission deliverables to ensure all requirements are completed according to timelines and quality expectations
- Manage offshore Clinical Trial Support Specialists and eTMF Quality Reviewers. Provide training, support, and coaching as required
- Help define the TMF control framework and related monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms including both process quality and effectiveness aspects
- Maintain global expertise through training and participation at conferences and in industry forums. Maintain awareness of evolving standards, technology, and best practices and channel appropriate intelligence into our business model. Evolve the operating model as needed
- Utilize metrics and trend analysis to identify and prioritize process improvements. Provide data and input to drive other continuous improvement efforts across the enterprise as applicable, which may include priority and timing collaboration with other stakeholders
- Lead efforts to scope, plan, and implement process improvements including accountability for sustainable improvements; use appropriate change management and communication principles
- Drive standardization and efficiencies in the preparation of GDO submission deliverables
- Drive timelines within the submission deliverable team to ensure on-time deliverables to the overall submission
- Collaborate and coordinate deliverables from outside parties such as NCI and COG in collaboration with Legal and Procurement to establish contract/payment for project deliverables
- Collaborate with Global Trial Managers, Operations Leads, Submission Managers, GBS, Medical Leads, Program Leads, and Development Leads on the coordination of document preparation such as financial disclosure memos, FDA forms, enrollment reports, Module 9 for EU filing
- Drive the development and implementation of various initiatives and automation opportunities to ensure the highest quality and compliance is achieved
- Prioritize book of work for CTSS and eTMF Operations teams and assign resources based on priority projects
- Collaborate across multiple functions supporting clinical trial processes to ensure adherence to regulatory requirements
- Ensure training and support to internal and CRO teams on eTMF and CTMS technical aspects as needed
- Maintain continuous knowledge of the regulatory requirements and industry trends related to TMF compliance
Submission Document Manager, Oncology Clinical Operations Strategy
Bristol-Myers Squibb Company
2019 - 2022
- Manage the development and finalization of GCO protocol-related submission deliverables to ensure all requirements are completed according to timelines and quality expectations. This includes Financial Disclosure packages, OSI Site Level Data Listings, OSI Reviewers Guide, BMS Employment Check, and CRF PID and Word list
- Drive standardization and efficiencies in the preparation of GCO submission deliverables
- Contribute toward building efficiencies into the Submissions Operating Model.
- Attend submission-tracking meetings and manage the collaboration with the Clinical Trial Support Staff (NACC) for the development of their submission deliverables, i.e., CSR Appendices, Financial Disclosure Tables, etc
- Drive timelines within the submission deliverable team to ensure on-time deliverables to the overall submission
- Collaborate and coordinate deliverables from outside parties such as NCI and COG in collaboration with Legal and Procurement to establish contract/payment for project deliverables
- Collaborate with Protocol Managers, Operations Leads, Submission Managers, GBS, Medical Leads, Program Leads, and Development Leads on the coordination of document preparation such as financial disclosure memos, FDA forms, enrollment reports, Module 9 for EU filing
Sr. Manager, Clinical Document Management Group, Global Regulatory Safety & Biometrics
Bristol-Myers Squibb Company
01.2016 - 01.2017
- Responsible for leading, managing, and developing a team of Clinical Document Management Specialists
- Optimize document development processes through identification of efficiencies, resolution of issues, and skillful stakeholder management
- Review, monitor, and distribute document workload among Clinical Document Management Specialists
- Identify areas for process improvement & standardization
- Liaise with DMC, CSC, and the NGA Leadership team to address technical issues and process issues related to the development and finalization of protocol documents
- Communicate Clinical Document Management Specialists updates via team meetings
- Core Team member of the Program and Protocol Development Operations Forum
- Key member of Protocol Control Change Board, and reviewer of clinical protocol model documents
Protocol Technical Specialist, Global Development Operations, Global Clinical Operations & Strategy
Bristol-Myers Squibb Company
01.2012 - 01.2014
- Provide documentation support to the Protocol Managers with authoring documents
- Mastery of CARA and BMS Core Template and Model Documents
- Provide technical support to all Authors regarding CARA and BMS Core Template and Model Documents
- Complete Quality Assurance checks on all documents to ensure they are submission ready
- Prepare Compare documents to complement revised Protocols and Global Amendments
- Present ad hoc training to teams regarding Model Documents, Core Template, and CARA prior to authoring documents to establish a team working environment and help to facilitate gaps with document approval
- Liaise with the DMC, CSC, and NGA team to address issues with documents or processes
- Provide training and mentoring to new PTS team members
Senior Clinical Trial Associate, Global Development Operations, Global Clinical Operations & Strategy
Bristol-Myers Squibb Company
01.2011 - 01.2012
- Provide lead clinical trial support to Clinical Teams to drive the study start-up process across multiple projects simultaneously including but not limited to: negotiation of Confidentiality Agreements, tracking of site feasibilities, creation of Regulatory Binders, patient diaries, and shipment of study supplies
- Provide effective support to internal and external stakeholders for Dapa (073/077) study start-up team
- Liaise with Site Management and Global Recruitment/Analytics groups to support site selection process
- Monitor and maintain study site progress within IMPACT and assist as needed to ensure protocol and regulatory compliance
- Proactively complete project deliverables to meet study timelines
Clinical Trial Associate II, Discovery Medicine & Clinical Pharmacology, Clinical Science & Operations
Bristol-Myers Squibb Company
01.2010 - 01.2011
- Provide operational support to clinical teams to assist with the execution of early, full, and/or late-stage development projects
- Collaborate with study teams on U.S. and Ex-U.S clinical trial start-up activities working across therapeutic areas. Prepare clinical trial packages
- Prepare regulatory binders for U.S. sites
- Organize, review, and track regulatory documents
- Set up new sites in IMPACT and my Trials/TAO
- Maintain study timelines in IMPACT to ensure they are current following monthly reports such as ISRT, Action Item, and Country Exception report
- Collaborate with study teams and medical writers in preparing CSR Appendices and uploading to CARA
- Complete the TAO archival CD process for completed sites
Executive Associate I, Executive Assistant, Senior Administrative Associate, Administrative Associate
Bristol-Myers Squibb Company
01.2000 - 01.2010
- Administrative support for (2) Executive Directors and (9) Directors
- Manage calendar by determining the priority of the meetings, working to eliminate scheduling conflicts when possible, and scheduling meetings as necessary
- Coordinate business-critical meetings requiring coordination of submissions, agendas, and collection and posting of comments and action items
- Coordinate logistics for Investigator meetings bringing multiple sites together for study-related training
- Collaborate with protocol study teams, BMS legal, and Procurement to establish effective contracts
- Maintain HRIS database to include: job postings, terminations, promotions, and reporting structure and ensuring all information is accurate
- Assist in interviewing candidates at various levels for open positions within the department by scheduling job candidates to include scheduling, working with recruiters, and travel arrangements and candidate review meetings
- Member of the CD/Virology SLT where responsibilities encompass building agendas, creating action items, and ensuring that the members of the SLT complete action items and follow-up in order to meet specific objectives
- Ability to prioritize multiple tasks to meet or exceed project deadlines
- Negotiate contracts with medical personnel for the purposes of consulting
- Set up service orders in SAP, work with purchasing, global strategic sourcing, and legal to ensure vendors are appropriately aligned with vendor policy 50
Administrative Assistant
Bristol-Myers Squibb Company
01.1998 - 01.2000
- Support Director, Laboratory Operations Manager, and Staff
- Maintain monthly support staff meetings
- Coordinate support staff schedules to ensure full coverage
- Data entry into LIMS (Laboratory Information Management System)
- Maintain personnel files, org charts, temporary personnel lists
- Process lab supply orders, including troubleshooting
- Maintain master investigator list for all study sites
Office Manager/Optometric Technician
Michael & Sidney Newman, O.D.
01.1992 - 01.1996
- Scheduling of four staff members
- Ordering contact lenses for patients and maintaining stock inventory
- Processing insurance forms
- Working with special needs “low-vision” patients
- Monthly billing receivable and payable
- Teaching adults and children proper care for contact lenses
Education
MBA - Masters of Business Administration
University of Phoenix
Bachelor of Science - Business Management
University of Phoenix
Medical Office Assistant Certificate -
Mercer County Vocational School
Certified Nurses Aid Licensure -
Mercer County Vocational School
Skills
- Relationship building
- Strategic planning
- Verbal and written communication
- Decision-making
- People management
- Employee development
- Partnerships and alliances
- Business administration
- Team building
- Stakeholder engagement
Timeline
Sr. Manager, Clinical Document Management Group, Global Regulatory Safety & Biometrics
Bristol-Myers Squibb Company
01.2016 - 01.2017
Protocol Technical Specialist, Global Development Operations, Global Clinical Operations & Strategy
Bristol-Myers Squibb Company
01.2012 - 01.2014
Senior Clinical Trial Associate, Global Development Operations, Global Clinical Operations & Strategy
Bristol-Myers Squibb Company
01.2011 - 01.2012
Clinical Trial Associate II, Discovery Medicine & Clinical Pharmacology, Clinical Science & Operations
Bristol-Myers Squibb Company
01.2010 - 01.2011
Executive Associate I, Executive Assistant, Senior Administrative Associate, Administrative Associate
Bristol-Myers Squibb Company
01.2000 - 01.2010
Administrative Assistant
Bristol-Myers Squibb Company
01.1998 - 01.2000
Office Manager/Optometric Technician
Michael & Sidney Newman, O.D.
01.1992 - 01.1996
Director, Global CT Documents Submissions and eTMF Operations Lead
Bristol-Myers Squibb Company
2022 - Current
Submission Document Manager, Oncology Clinical Operations Strategy
Bristol-Myers Squibb Company
2019 - 2022
MBA - Masters of Business Administration
University of Phoenix
Bachelor of Science - Business Management
University of Phoenix
Medical Office Assistant Certificate -
Mercer County Vocational School
Certified Nurses Aid Licensure -
Mercer County Vocational School
Awards
Multiple Ovation and Bravo Awards received for outstanding results, leadership development & exceeding regulatory Submission Timelines.