SUMMARY:

• Dynamic and resourceful individual who sees the “big - picture” and creates detail in developing Standard Operating Procedures as well as writing end-user documentation within a highly regulated industry.
• Demonstrated expertise in writing corporate process documents and formulating structure for quality processes for company.
• Instrumental in writing, developing and tailoring business processes as a technical writer. Stellar record of performing research, reviewing (Key Performance Indicators) KPIs, interviewing technical staff (SMEs), and ensuring projects are completed within given time.
• Instrumental in authoring, editing and approving technical documents, including user forms, manuals, white papers, annual reports, presentations, tutorials, and Web content.
• Demonstrated success in developing and implementing strategic plans as well as collaborating, training, and mentoring teams to accomplish organizational goals.
• Vendor Selection & Onboarding
• Project & Operations Management
• Training & Development
• Technical Writing
• Process Improvement Initiatives
• Team Building & Collaboration
• ICH/GCP, GDPR, CFR, ISO, HIPAA, PHI,PII
• Content Management

KEY AREAS OF EXPERTISE:

• Strong Collaborator & Communicator; expert leader to lead virtual teams.
• Possess both breadth and depth of industry acumen while having freelanced both on the client side (Pharmaceutical, Device) with a record of repeat call-backs for individual contract work before entering the service provider side (CRO).
• Create, develop and streamline global corporate structural processes (SOPs, Forms, Guides, Work Instructions, Manuals) within a highly regulated industry and per ICH/GCP guidelines. Tailored process documents per local country regulations and ISO 9001 standards where applicable.
• Organize and empower international teams to accurately submit for local country competent authority Clinical Trial Applications & Ethic Committee Submissions for regulatory approvals
• Process and content development; editing for patient engagement & training materials developed to obtain regulatory approval. SOPs, policies, forms, WI, Plans etc.
• EU-GDPR, HIPAA, Personal Identifiable Information (PII), Personal Health Information (PHI)
• Track record of rescuing projects within a regulated industry and delivering positive and improved clinical operations start up metrics by deconstructing and localizing root cause and leveraging efficiencies for positive outcomes

TECHNICAL SKILLS:

Technical Proficiencies: MacOS and Windows operating systems, Trackwise, ELS (eLearning Systems), Clinical Trial Management Systems (CTMS, eTMF, EDCs), Virtual Meeting Platforms (WebEx, Zoom, GoToMeeting, Microsoft Teams, GoogleChat), Collaborative workspaces (DropBox, Box, SharePoint, Google Drive, One Drive), Microsoft Suite (MS Word, Excel, PowerPoint, Outlook), Adobe

EXPERIENCE:

Consultant

Confidential

Responsibilities:

• Partnering with global clients remotely to implement strategic initiatives for business growth.
• When required, consult on their internal business processes for improvement; develop current/future state process maps.
• Optimize business leads for clients in Canada, Europe and the States.
• Develop Quality Management System’s (QMS) architecture, consult to optimize existing business processes within clinical and technical industries.

Chief Compliance Officer

Confidential

Responsibilities:

• Delivered exceptional leadership and guidance to senior quality management personnel for prompt delivery on corporate quality initiatives to ensure high-level quality in operations.
• Envisioned and employed risk management approaches in interdisciplinary team environment, while deploying quality consistency at global level.
• Steered GDPR, PII, PHI compliance principles, ICH/GCP regulations, ISO standards, while strategically positioned as SME for data privacy.
• Developed structural processes within a high virtual team environment by providing effective leadership.
• Created quality corporate process framework, promoted frequent gap analyses to nurture a culture for consistent improvement based on team feedback and collaborations.

Strategy & Clinical Compliance Officer

Confidential

Responsibilities:

• Spearheaded and mentored project teams in developing and improving process, work instruction, forms/guides to meet current regulatory requirements for a robust Company Quality Management System (QMS).
• Established and conducted company training program including implementing an electronic document management system to meet and exceed set performance goals.
• Ensured transparency and accuracy in operations by hosting GCP sponsor company audits, performing vendor audits and implemented CAPA plans in response to audit findings.
• Administered/maintained business critical vendors: collaborated with external IT partner in improving business disaster recovery, developing business continuity plans and were operationally aligned to business model.

Director of Operations

Confidential

Responsibilities:

• Developed high-performing teams by overseeing vendor selection and onboarding to support clinical trial operations in areas of data management (EDC), clinical trial document translations and clinical trial systems.
• Nurtured a collaborative team environment for growth/development as well as formulated team training programs to ensure continuous performance improvement.
• Developed/administered social media accounts for company, including (Twitter, LinkedIn) for business development team.
• Served as company DPO representative for EU development in support of Company growth.
• Achieved fast track promotion to operationally recruit, train and oversee team's day to day tasks for European CRA/Project Manager/Associate Director/Regulatory and support organizational growth.
• Updated/maintained negotiation processes regarding data privacy languages for site contract full executions.

Global Program Manager

Confidential

Responsibilities:

• Conducted diverse range of several study roles in global Phase III/IV clinical trial program, including having co-monitored as the lead CRA for quality assurance in Germany, Switzerland, France and Italy.
• Executed and delivered primary CRA task requirements including investigational product reconciliation, data query management, Serious Adverse Even (SAE) reporting, and regulatory submissions to ethics committees. Manage creation and improvements of technical documents from Policies, Standard Operating Procedures to Disaster & Recovery.
• Implemented company’s first collaborative sharespace and trained teams on usage globally.
• Performed monitoring tasks for 50+ centers globally at one time either as primary monitor, or as co-monitor to supervise monitoring quality assurance and ensuring delivery of corresponding monitoring trip reports to meet or exceed project delivery metrics.