Summary
Overview
Work History
Education
Skills
Websites
Affiliations
Technical Skills
Timeline
Generic

Stuart Donaldson

San Carlos,California

Summary

Experienced clinical data management professional and accomplished leader with a proven track record of steering clinical trials through approval, delivering innovative solutions, and executing strategic initiatives. Consistently promoted to higher levels of leadership due to demonstrated competence in staff development, business management, partnerships, portfolio-based resourcing, and operational excellence. These qualities have led to a significant increase in the effectiveness, efficiency, and quality of program delivery and activities within teams.

Overview

33
33
years of professional experience

Work History

Sr. Director and Global Head CDM

Nestle Health Sciences
01.2020 - Current
  • Led global CDM team managing all Pharma clinical trials (Phase I Phase III) and Nutritional Health studies.
  • Directed team of internal staff, contractors, and outside vendors including CROs and systems providers.
  • Implemented studies from protocol development through database lock
  • Developed budget for resource allocation
  • Work collaboratively with heads of Biometric, ClinOps, Quality, Regulatory, Legal, Clinical Development, IT

Sr. Director, Clinical Data Management

AIMMUNE THERAPEUTICS
03.2017 - 01.2020
  • Formed and led Clinical Data Management team responsible for Palforzia immunotherapy approvals - including pivotal trials leading to US and European approvals and supplemental approvals.
  • Responsible for the oversight of all data management (DM) activities - Case Report Form (eCRF) development, database design, Data Management Plans (DMPs), Standard Operating Procedures (SOPs), implementation of edit check programs, data quality assurance, data delivery and database closure.
  • Responsible for tracking vendors’ important data management study metrics. Work collaboratively with internal and external groups to insure study data quality.
  • Hired and mentored new team members.

Rotation: US Medical Affairs DATA Group

Genentech
06.2016 - 03.2017
  • Co-Lead of USMA Evidence Generation (EG), Business Process Management Excellence Project (BPME). This project optimizes the quality of business process documentation, reducing duplication between EG Functions and supports the efficient storage of documentation for internal users and potential auditors
  • Liaison for USMA DATA Group Functional Service Provider Implementation team - to define the detailed documentation USMA will use to conduct studies using in-house database management systems, e.g., Rave
  • Optimized quality of business process documentation

Director and CDM Therapeutic Area Head for gRED

Genentech
10.2012 - 03.2016
  • Responsibilities: contributed as a member of the global CDM leadership team to provide strategic direction and leadership in order to maximize our effectiveness to deliver on the portfolio; led the gRED (Genentech Research and Early Development) CDM Therapeutic Area; established the CDM vision, mission, and strategy; ensured gRED strategies were known, understood, supported and implemented by global CDM; recruited, inducted, retained, and developed staff through coaching and mentoring; ensured staff well-being; ensured gRED CDM projects were delivered on time; supported a culture of innovation; ensured budgets were set, tracked and reported effectively
  • Significant Accomplishments: co-led global CDM productivity enhancement initiatives from inception through change management and embedding; sponsored EDC productivity initiatives (PI Signature Simplification; Medidata Capabilities Assessment); sponsored gRED Clinical Data Collaboration; sponsored gRED TCS adoption

Director and CDM Site Head for gRED

Genentech
09.2009 - 10.2012
  • Responsibilities: created the gRED unit within global CDM; optimized global CDM practices through connecting with members of the new global CDM leadership team; connected gRED with the broader CDM global organization; coached, supported, and lead staff; ensured that the performance of Data Management staff at the site was proactively managed, trained, and developed; ensured resource planning and site productivity; was accountable for portfolio delivery, budgeting and process improvements; ensured that staff communication and employee relations were managed proactively to maximize the well-being of staff; established and maintained relationships with key partners
  • Significant Accomplishments: established gRED as a new and significant contributor to global CDM; established global relationships within the product development organization in order to facilitate study execution provided leader coaching to managers; established team roles and responsibilities; defined work processes; managed stakeholders; developed budgets and managed resourcing

Director and Site Head of CRED Data and Process Management, SSF

Roche
07.2009 - 09.2009
  • Responsibilities: provided management, coaching and CDM expertise to local CRED staff; planned, allocated and prioritized data management resources, budgets and goals; ensured execution and delivery of studies, compliance to GCP guidelines, company SOPs, standards and departmental processes; drove operational excellence; managed relationships; established goals, expectations and accountabilities for staff; provided staff feedback, evaluation and recognition
  • Significant Accomplishments: established a new team to support gRED studies under Roche Early Phase; represented South San Francisco on a new international team in order to merge Early Phase development teams from Europe and the U.S.; established roles and responsibilities; defined work; managed stakeholders; developed budgets and resourcing

Associate Director and Head of CDM Specialized Operations

Genentech
08.2008 - 07.2009
  • Responsibilities: broadened the scope and size of the CDM Specialized Operations group which included SAS clinical programming, laboratory data management, study database build, IVRS specification, and Global Library Management; ensured project timelines and budgets for clinical coding
  • Significant Accomplishments: Grew an existing group in order to increase the CDM focus on technical capabilities and enhance their ability to contribute as a group; established roles and responsibilities; defined work processes; managed stakeholders; developed budgets and managed resourcing

Sr. Manager and Head of CDM Study Initiation Group

Genentech
03.2007 - 08.2008
  • Responsibilities: launched the CDM Specialized Operations group which included SAS clinical programming, laboratory data management, study database build, IVRS specification, Global Library management and EDC Project Management
  • Significant Accomplishments: established a new group in order to gather and focus technical expertise; established roles and responsibilities; defined work; managed stakeholders; developed budgets and resourcing

Sr. Manager and Head of CDM EDC Services Group

Genentech
03.2006 - 03.2007
  • Responsibilities: Established and led a new group tasked with delivering EDC capabilities using RAVE; managed groups dedicated to EDC study implementation: EDC Training, EDC Account Management, Study EDC Project Management and Dedicated EDC Help Desk oversight.
  • Significant Accomplishments: Helped establish EDC as a major data collection portal at Genentech; established new group to manage EDC: established roles and responsibilities; defined work processes; managed stakeholders; developed budgets and resourcing

Sr. Manager

Genentech
10.2004 - 07.2006
  • Responsibilities: managed Clinical Data Coordinators for the Cardiovascular and Bio Therapeutics Areas
  • Significant Accomplishments: co-led establishment of Functional Service Provider resourcing model; co-led the Process Team for the EDC Scale-Up Initiative

Manager of Project Data Managers

Genentech
03.2001 - 10.2004
  • Responsibilities: managed Clinical Data Coordinators for the Cardiovascular and Bio Therapeutics Areas
  • Significant Accomplishments: co-led establishment of Functional Service Provider resourcing model; co-led the Process Team for the EDC Scale-Up Initiative

Sr. Clinical Data Coordinator

Genentech
12.1999 - 03.2001
  • Responsibilities: managed all clinical data for Growth Hormone Therapy studies
  • Significant Accomplishments: led the organization’s initial investment in EDC as the Project Manager for the Remote Data Collection Pilot

Clinical Data Coordinator II, Sr. Clinical Data Coordinator

Genentech
06.1997 - 12.1999
  • Responsibilities: managed clinical data for all Product Experience post-marketing studies
  • Significant Accomplishments: established clinical data management practices for the Post-Marketing group; first internal Clinical Data Manager for Post-Marketing Studies; brought data management best practices to a group with no prior in-house expertise

Clinical Data Specialist

Genentech
01.1995 - 06.1997
  • Responsibilities: clinical data management for the Cardiology/Stroke Therapeutic Area including: Phase II & III, pharmaco-economic, post marketing, registry and Integrated Safety studies
  • Significant Accomplishments: prepared data for successful IND submission of t-PA for stroke

Supervisor, Clinical Data Operations

Applied Immune Sciences Inc.
02.1992 - 01.1995
  • Led CDM team for startup biotech company developing therapies for hematologic disorders, oncology, and infectious diseases using sterile, monoclonal antibody-coated devices to purify hematopoietic stem cells for use in autologous transplants.

Education

Masters of Public Health - Epidemiology

San Diego State University
01.1991

Bachelor of Arts - Biological Sciences, emphasis in Evolutionary Biology

University of California at Berkeley
01.1989

Skills

  • Clinical Data Management
  • Knowledgeable in Regulatory Guidelines and Industry Standards
  • Clinical Trials: POC – Phase 4
  • Global Team Leadership
  • Business/Finance Management
  • Operational Excellence / Culture transformation
  • Talent Development
  • Collaboration with internal partners and vendors
  • Innovation Implementation
  • Business process optimization
  • EDC Systems and Standards Implementation
  • Collaborative leadership as Group Head
  • Policy development

Affiliations

  • Medidata Users Group – Founding member, 2005; hosted U.S. National Meeting, 2008; 2 Innovation Awards
  • Society for Clinical Data Management: Certified Clinical Data Manager, 2004 (charter member)
  • Drug Information Association
  • Oracle Clinical Users Group

Technical Skills

Microsoft Suite, UNIX, Macintosh, Windows, SQL, SAS, Oracle Clinical, Veeva (CTMS, EDC, eTMF ) Medidata: (Rave, RTSM, eCOA, Coder)
Chat GPT (internal to Nestle)

Timeline

Sr. Director and Global Head CDM

Nestle Health Sciences
01.2020 - Current

Sr. Director, Clinical Data Management

AIMMUNE THERAPEUTICS
03.2017 - 01.2020

Rotation: US Medical Affairs DATA Group

Genentech
06.2016 - 03.2017

Director and CDM Therapeutic Area Head for gRED

Genentech
10.2012 - 03.2016

Director and CDM Site Head for gRED

Genentech
09.2009 - 10.2012

Director and Site Head of CRED Data and Process Management, SSF

Roche
07.2009 - 09.2009

Associate Director and Head of CDM Specialized Operations

Genentech
08.2008 - 07.2009

Sr. Manager and Head of CDM Study Initiation Group

Genentech
03.2007 - 08.2008

Sr. Manager and Head of CDM EDC Services Group

Genentech
03.2006 - 03.2007

Sr. Manager

Genentech
10.2004 - 07.2006

Manager of Project Data Managers

Genentech
03.2001 - 10.2004

Sr. Clinical Data Coordinator

Genentech
12.1999 - 03.2001

Clinical Data Coordinator II, Sr. Clinical Data Coordinator

Genentech
06.1997 - 12.1999

Clinical Data Specialist

Genentech
01.1995 - 06.1997

Supervisor, Clinical Data Operations

Applied Immune Sciences Inc.
02.1992 - 01.1995

Bachelor of Arts - Biological Sciences, emphasis in Evolutionary Biology

University of California at Berkeley

Masters of Public Health - Epidemiology

San Diego State University

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