Dominique Barbeau

In addition to standard CRM role responsibilities;

- Mentor New CRMs

- Natural & highly respected "go-to" senior resource for CRM colleagues in general (in addition informal coaching/training to COM-Rs & CTCs)

- TAH support: upon request (or voluntarily offered) to assist CRM colleagues with issue-resolution and early risk identification across various indications, perform country feasibility assessments and validations (complex indications).

- Canadian Cluster Lead: General Medicine (previously: Melanoma & Lung Lead)

- Key point of contact for Canadian Centers of Excellence (Institution Partnership Initiative) and Key Opinion Leaders: JGH, MUHC, PMH, CCI & Sunnybrook for past 10+ years

Key Accomplishments:

- March to Dec2020: initiated & led Canadian COVID-19 Response Team as appointed by Country CRD: ensured proper alignment of different roles & knowledge-sharing of evolving site-specific situations vs impact on monitoring, management of issues specific to Canadian reality. Involved constant interactions with TAHs, CRA & CRM Managers, Country Clinical Quality Manager Team for alignment on issues vs Canadian reality (impact on patients, studies & site resources) & Global business needs.

Keytruda journey pioneer: initiated 1st trial in Canada: MK 3475-001 (melanoma and lung/NSCLC). Enrolled >70 patients (Global N= 1100)= 6% (2x typical accrual rate for Canada).

- Includes: Successful FDA Audit (01-05JUN2014): 14 melanoma patients reviewed. No 583 issued, excellent site documentation of ICF process and excellent monitoring and thorough reports

- Conducted validations & initiated trials in a multitude of new indications thereafter: breast, ovarian, prostate, Hodgkin's lymphoma, multiple myeloma (KN 006, 010, 022, 024, 042, 086, 087, 204, 252, 716 in addition to LEAP studies (partnership with Eisai): MK 7902-003, 004 & 005

- Initiated KN 587 (2018): Global Extension Trial

- Initiated Canadian Overall Survival workstream (Co-Lead with SrCOM) & closely interacted with Merck Canada Legal & Global ICF SMEs to properly gage country-level impact & carefully address sensitive topic with PIs & Sites

- Volunteered as CRM Liaison for Data Management (2015-2020) Initiatives/Process Improvement:

• GDMS/GCTO Interactions: monthly calls (March 2020-Dec2020)
• Contemporaneous Data Process: Nov2017-Mar2020
• Query Value Project: Jun-Dec2018
• Canadian Overall Survival workstream Co-Lead: 2017-2019

Adaptive Integrated Monitoring (AIM): GCTO's Highest Priority Initiative. Assigned SOP & Implementation Workstream Lead. Key responsibilities; 1- coordinated updates to existing GDC documents & finalization of new AIM Process Documents through ongoing support to AIM SMEs and liaising with GCD Leads (resulting in successful finalization of all updates by set milestone: 29OCT2021 & GCD submission on 10Jan2022), 2- constant collaboration with REAIM Sub-Team Leads & Training and Communication workstream leads: facilitate onboarding of new studies (Exceptional/Early Adopters) 3- created Process Exception Instructions & ensured adequate & timely requests/approvals for AIM Pilots & Early Adopter studies 4- Attended Monthly AIM Sponsor Meetings (progress reporting & reaffirming alignment with key mandate)

Digital Health Technology (February to October): Co-Led Transition Workstream (mandate; reduce DHT adoption challenges in late-stage clinical trial setting). Hosted weekly calls, actively contributed to development of Transition checklist & associated guidance. Collaborated closely with Process & Governance Co-Leads for alignment of all deliverables in scope for Initial DHT project. Played key role identifying existing gaps & further improvements required for DHT 2.0.

Site Focus Newsletter (Quarterly throughout 2021): coordinated content selection, article development, review/approval & release cycles in close collaboration with PMO Director & Sr Director.

Spectrum CleanUp/Spring Campaign (January to September): in support of GCTO 2021 Quality Goal to -> "Ensure integrity of the data entered into SPECTRUM to drive compliance..." : played key role in development of Spectrum Spring CleanUp Communication campaign, in close collaboration with Communications Team; resulting in a 23% reduction of missing data points (confirmed by June reports). Also collaborated to creation of new tools (CRA Tip Sheet, Manager Instructions, Quiz, etc...) and addition of new CleanUp tile in SPECTRUM Sharepoint for easy retrieval of useful resources paralleled with increased frequency + visibility of standard metrics for all roles.

electronic Clinical Outcome Assessment (eCOA) End to End redesign (February to June): led Training & Communication workstream in close collaboration with PMO Project Lead and involving multiple functional area representatives (ME, CSSM, Procurement, GDO & GDMS SMEs); managed weekly calls, documented progress & tracked successful completion of all required SOP updates & associated documents

Contribution to Surveys:

- Internal CLMS targeted survey (April to June): collected user stories from key Country Ops roles impacted (CRAs, CRA Managers, TAHs & PLMs ) to gain a better understanding of current state & challenges related to CLMS. Co-developed list of questions.

- Internal SIP Survey (February to April): analyzed free text comments to assist PMO Director/Project Lead with identification of major pain points and confirm areas for quick wins (vs longer term areas of improvement).

· Responsible for quality and compliance of assigned protocols. Performed quality control visits, reviewed Monitoring Visit Reports and escalated performance issues and training needs to functional vendor and internal management as needed (Merck embedded program/oncology franchise)

• Prepare the project plan/timelines and monitor project progress; quickly identify issues and implement corrective corrective actions. Execute study within set timelines and according to available resources & budget
• Serve as primary contact person for Sponsor during trial conduct & lead regular project progress meetings.
• Review and approve study documents. Identify the participating study sites. Generate project status reports. Provide functional oversight to project assistant.
• Evaluate current processes for efficiency and quality and make recommendations for improvements. Assist in key departmental initiatives

• Managed the Canadian segment of an International Project targeting atherosclerotic patients (encompassing 3 different imaging Core Laboratories).
• Coordinated logistical aspects: special site training sessions (imaging), liaised with suppliers to arrange shipping of equipment & ensured sites were certified in a timely fashion.
• Daily activities included: standard progress reporting, scope and budget review, timeline tracking, daily interactions with Sponsor, internal mentoring and guidance to project team (CRA Team & Data Management) as well as ensuring continuous data quality and adherence to SOPs. Also included regular interactions with all associated vendors (IVRS, CEVA & Central Reference Laboratories, Pharmacogenomic Laboratory) based on study scope.

Line Manager Role (2 years): Managed team of CRAs & Clinical Trial Coordinators. Included: performance evaluations of direct reports, tracking progress against company objectives, mentoring & continued collaboration & executive progress reporting to Clinical Research Director & Scientific Affairs Vice-President.

• Managed Canadian studies involving 2 different molecules (as well as assigned in-house CRA Team and Clinical Support Specialist).
• Served as primary contact when collaborating with CROs (Data Management, Statistics, Pharmacovigilance, Medical Writing, etc…). Assisted Senior Director in proposal/bid reviews and final CRO selection.
• Participated to Monthly Program Reviews (involving Business Development, Scientific Affairs VP, pre-clinical and key clinical staff) and Weekly Project Review Meetings.
• Actively involved in elaboration of new SOPs, preparation of clinical research protocols, informed consent forms, as well as amendment-related modifications (protocols and ICFs), including submissions to TPD. Collaborated to the Investigator Brochure.

Line Manager Role (2 years):

Conducted performance appraisals (CRAs & CTCs), mid-year reviews, followed-up on training needs and/or staff career development opportunities.

• Acted as International Project Leader for an oncology study in the following countries: Canada, Belgium, United States, Germany, Italy and France.
• Planned & carried out Investigator Meeting in Barcelona, in addition to facilitating Investigator Meeting/CRA Training as well as Site Coordinator Training sessions.
• Conducted performance appraisals, mid-year reviews, followed-up on training needs and/or staff career development opportunities.
• Tracked budgets per Scope of Work, as well as monitored need for any potential Change Order, performed associated follow-up with internal Finance Group as well as Sponsor representatives.

Global Project Lead for International Ph IV registry study involving: Canada, France, Denmark, United States, Germany and Australia. Managed Scope of work, objectives, and other PM activities for directly assigned projects.

• Line Manager Role (1.5 years):

- Managed team of 30+ DM staff

- Attended North American weekly teleconferences with other NAMR DM Heads to discuss pipeline and project allocation strategy

- Ensured qualified resources were assigned to new projects and actively tracked overall progress, early identification of issues for proper escalation & efficient resolution
- Closely collaborated with Clinical, Biostatics, Pharmacovigilance, Regulatory & Financial Directors

- Conducted annual performance evaluations: based on established metrics & performance indicators

- Ensured general oversight & progress of all departmental activities, achievement of study-specific milestones, budgets paralleled with overall adherence to company quality & compliance standards

Line Manager Role (1 year):

- Managed team of 6-8 DM staff
- Ensured qualified resources were assigned to projects, monitored overall progress and adherence to quality standards, promoted early issue identification & prompt resolution
- Closely collaborated with DM Director & Biostatics Director
- Conducted annual performance evaluations: based on established metrics & performance indicators
- Provided general oversight of all departmental activities, quick isse resolution, achievement of study-specific milestones, budgets paralleled with overall adherence to company quality & compliance standards

- Mentored/trained Data Managers and Data Entry Coordinators

Lead Data Manager representing the Clinical Data Management team on the corporate project team.

Prepared study designs, developed protocols, generated informed consent forms, tracked project progress. Performed routine parameter calculations and statistical analysis, interpretation of results and production of final report.