A multi‐faceted life sciences technologist offering 20+ years’ progressive experience in envisioning curriculum, building teams and processes to effectively translate technical and scientific concepts into client engagement programs.THERAPEUTIC AREA EXPERIENCE INCLUDES: Arthritis, Cardiology, Endocrinology, Genetic Disorders, Gynecology Hepatology, Immunology, Nephrology, Neurology, Oncology, Pain Management, Psychiatry/Psychology, Respiratory, Sleep, Urology, VaccinesREGULATORY EXPERIENCE:Well‐versed in GxP/ICH/21 CFR guidelines and regulations. Have written and created training for SOPs, work instructions and other QSM documents. Have participated in vendor and internal audits. Issued or responded to corrective actions.
Retirement
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RetiredRetirement Mar 2023 - Present
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Principal ConsultantBynara, Ltd. Apr 2020 - Mar 2023Rockport, Massachusetts, United States- For a growing oncology/infectious disease company, overseeing the implementation of a clinical operations platform, including sub-projects like integration, migration, business process, data standards, change management, governance and training strategy.- Created learning strategy for small biotech organization. Included learning platform infrastructure, GxP compliance objectives, optimal delivery modalities (microlearning, social learning, R&U, instructor-led), department/role/activity-specific curriculum and a training governance structure. Helped to identify and recruit resources to operationalize the strategy.- For a small medical device company, created a GxP elearning curriculum, including custom content, selecting 3rd party partners for off-the-shelf curriculum and establishing a network of instructional designers/content developers to handle the fluctuating demands for content development.
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Principal ConsultantCellarity (Contract) May 2021 - Aug 2021Cambridge, Massachusetts, United StatesLed an initiative to identify and select a laboratory information management system for a small company using machine learning to develop new medicines.
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Principal ConsultantEqrx (Contract) Aug 2020 - Aug 2021Cambridge, Massachusetts, United StatesProgram/project manager for several Veeva Vault implementations for R&D and Quality. Responsibilities included:- Program management- Project management- Business process optimization- Workflow design- Documentation (SOPs, work instructions, project records, job aids)- Instructional design (eLearning for applications, clinical operations and computer systems validation)- UAT design and implementation
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ConsultantDiligent Pharma Apr 2020 - Aug 2020Remote• Relationship manager for major clients of GCP vendor qualification platform. o Day-to-day contact for three Top 5 global pharma clients• Sales support including presentations, follow-up, RFPs• Creating and writing quality management system, including SOPs and work instructions. -
ConsultantDiligent Pharma Apr 2020 - Aug 2020Remote• Relationship manager for major clients of GCP vendor qualification platform. o Day-to-day contact for three Top 5 global pharma clients• Sales support including presentations, follow-up, RFPs• Creating and writing quality management system, including SOPs and work instructions. -
Practice Manager, TrainingVeeva Systems Jul 2018 - Apr 2020Rockport, Ma- Ensure end users and customers are happy by building, refining, deploying exceptional learning experiences through eLearning, instructor-led or a blended approach.- Envision and create enterprise Enablement curriculum.- Lead a team of instructional designers and technical training trainers.- Establish and oversee EDC Services onboarding program.- Customer program management/relationship support.- Sales support.- Customer audit support. -
Principal ConsultantSelf-Employed Dec 2017 - Jul 2018Greater Boston Area For a meeting planning organization:o Revamped a instructor-led course focused on healthcare meeting compliance. Included new PowerPoint deck with detailed speakers notes, new graphics, facilitator’s guide and participant handbook. For a oncology biopharmaceutical company:o Worked with QA (GCP, GLP, GVP, GDP) to create a training strategy for new/revised SOP releases. Created standard process, templates, SharePoint site, job aids, and coached subject matter experts on best practices for creating short training events.o Created a presentation to be presented by a senior director at an industry conference focused on quality innovations.
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Director Of Learning And Operational ExcellenceCogstate Feb 2016 - Nov 2017New Haven, Ct• Devised and implemented a new learning approach for external training for clinical raters. • Key member of client/partner governance committee responsible for implementing new technologies/processes which resulted in decreased project costs, higher profit margins and new business opportunities.• Frequent collaborator with CBO/Marketing on business development/marketing initiatives, including RFPs, bid defenses, webinars, and coaching field staff.• Devised and implemented a new learning approach for training cognitive raters. New approach resulted in Cogstate being awarded preferred provider status for a Lilly’s Alzheimer’s Disease program.• Hired and developed Cogstate’s first learning development team. • Evaluated, selected and deployed a new Learning Management System (LMS) for internal and external use. -
ConsultantBynara Ltd Sep 2006 - Feb 2016Rockport, Ma• For a world-wide EDC firm, deliver generic or customized user training as well as train-the-trainer and enterprise adoption programs. Also, am leading business process optimization sessions for client engagements.• For a growing CRO and a small biotech, designed, wrote and delivered catalog of EDC-related training materials for multiple audiences globally. •For a global clinical EDC firm, designed and implemented a standard business process optimization offering.• For an international clinical organization, designed and developed training curriculum (online and teacher-led) for a suite of services and offerings for a variety of software applications (e.g., business, project staffing/resource management, clinical); trained and mentored global team of trainers. • Offered guidance to a global CRO on how to manage EDC within the constructs of their current CTMS application while improving their vendor and clinical partnerships.• Delivered generic and customized EDC/IRT training in multiple settings, as well as train-the-trainer sessions. • Working with a major world-wide biotech, provided guidance related to training and adoption of EDC as well as consulting on course development (online and classroom).• Developed and delivered training curriculum for a growing CRO with staff in regional offices in US, Europe and South America; included clinical, project/staff management, staff allocation, and regulatory topics.• For a medium-sized global CRO, provided guidance for enterprise adoption of EDC in the areas of training, business processes, and best practices.• Working with the staff of a small biotech, designed and wrote catalog of training materials for multiple audiences (CRCs, CRAs, PIs, and sponsor staff); delivered train-the-trainer and reporting tools training. Also developed/delivered soft-skills curriculum to prepare staff to work with global partners at a leadership level.
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Senior Training Consultant (Contractor)Pht Corporation May 2014 - Mar 2015Greater Boston Area(PHT acquired by ERT in March 2014)- For client-facing training department, develop business processes and training curriculum that supports an expanding business.- With Science and Product Development, designed and delivered initial RATER training initiatives on hand-held devices, tablets and web interface; also worked with eLearning Developers to craft a storyboard shell to use for future RATER eLearning initiatives (internal, client, physicians).- Deliver training sessions at global investigator meetings.- Collaborate with eLearning developers and project teams to ensure training objectives are met and that materials are consistent across all learning modalities.- Initiated effort to bring the voice of the end user into product development; as a result, at least one trainer was assigned to each product development initiative.- Represented project/program managers at client meetings.- Reviewed applicable SOPs to ensure they were complete. Recommended changes to existing SOPs and drafted additional SOPs.- Worked with Oracle EBS team to improve timesheet reporting related to Education Services activities. The objective was to expedite reporting, provide a granular look at details without overburdening staff, project and track revenue more efficiently.- Initiated Train-the-Trainer and Proctor Training programs for project manager/coordinators. -
Training ManagerHumedica Jun 2012 - May 2013Greater Boston Area(Humedica was acquired by Optum Insight in February 2013)• Responsible for Humedica’s provider markets training program.• Collaborate with client services managers and clinical/technical subject matter experts to develop and deliver training programs and workshops to be delivered to provider market clients. • Facilitate meetings in the C-suite to drive data-to-decisions-to-actions initiative.• Work with healthcare analysts to help them understand the power of the combined EHR/claims data Bring the voice of the end-user to Product Development and Engineering. -
Pharma Group Marketing ManagerVivometrics, Inc. (Defunct) Apr 2002 - Sep 2006Ventura, California And Princeton, New Jersey• Global relationship management support for key at-risk clients.• Headed internal best practices teams charged with defining and implementing disciplined business processes.• Active sales team partner (including sales presentations/demo, creating a topical library, providing conference support, co-authoring white papers).• Designed and contributed subject matter expertise to “Vivo University” for staff, suppliers, and partners.• Created customer-facing training program; delivered both train-the-trainer and end-user training.• Coordinated scientific abstract/poster/presentation proposals and preparation, including researching opportunities, drafting proposals, editing documents and organizing supporting literature.• Developed and managed client project and department budgets; participated in developing sales compensation program/initiatives.• Identified KOLs/SMEs in two vertical markets; cultivated relationships and recruited for advisory boards. -
Director, Training And Technical ServicesEhealthdirect, Inc. (Defunct) Apr 2000 - Oct 2000Greater Boston Area• Responsible for eHealthDirect’s employee training activities.• Oversaw planning and contracts for equipment, consultants, and services.• Actively participated in product development initiative.• Built and promoted organization’s knowledge management activities.
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Director, Training ServicesPhase Forward Dec 1998 - Apr 2000• Responsible for Phase Forward Service’s customer and employee training programs.• Worked with internal and external subject matter experts to design programs to educate Phase Forward employeesworldwide about GCP guidelines, the clinical research process, as well FDA and ICH regulations.• Worked with clinical project teams to customize training to be delivered at investigator meetings.• Managed multi-discipline teams of internal & external resources; defined team skills, roles and responsibilities.• Recruited and mentored training team members worldwide. -
Director Support ServicesInstream Corporation (Defunct) Jun 1997 - Oct 1998Greater Boston Area• Differentiated the organization by selecting, training and leading a small, highly-effective, customer-centrictechnical and operations team, which receives more than 2000 calls each month.• Designed and conducted product-specific training programs for sales and service teams.• Defined, mapped, and implemented customer support and other related business processes.• Worked closely with Product Development/Marketing to introduce customer-ready, easy-to-use products.
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Manager, Support ServicesTasc Jun 1996 - Jun 1997Greater Boston Area• Hired and managed a geographically dispersed team of 25+ professionals responsible for maintaining, supporting, andtrouble-shooting computers, electronic communications and network infrastructure.• Wrote and implemented intra-departmental service-level agreements.• Implemented a customer advisory/advocacy board in order to facilitate communication and policy changes.• Envisioned and executed a mentor program for team members. -
Manager, Technology ServicesThe Forum Corporation Dec 1993 - May 1996• Designed and implemented an internal technology strategy with senior executives and network team.• Expanded company’s competitive advantage by developing technology-based training alternatives; demonstrated applicationsat international conferences and client engagements.• Developed and supervised implementation of global technology training plan for 300+ professionals. -
Project ManagerThe Forum Corporation Feb 1990 - Dec 1993Greater Boston Area• Successfully managed Forum’s first global client project.• Conceived, designed, and implemented system and data conversion for one of Forum’s primary leadership training products.• Worked with Product Development in converting two key instructor-led training products into computer-based training. -
Executive AssistantThe Forum Corporation Jan 1987 - Feb 1990• Supported the President of Forum North America.• Performed fact-checking for successful book on customer service.• Negotiated and organized speaking events associated with book tour. -
Executive AssistantThe Mac Group 1984 - 1988
Pamela B. Education Details
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Business Administration, International Business, Marketing -
French And Business Administration
Frequently Asked Questions about Pamela B.
What company does Pamela B. work for?
Pamela B. works for Retirement
What is Pamela B.'s role at the current company?
Pamela B.'s current role is RETIRED Experienced professional passionate about empowering individuals through exceptional learning programs and technology..
What schools did Pamela B. attend?
Pamela B. attended Bowling Green State University, University Of Oklahoma.
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