Robert Fontenot
Lake Charles,LA
Summary
Associate Director at Thermo Fisher Scientific specializing in data management and project oversight. Demonstrated success in risk assessment and budget management, enhancing project outcomes and client satisfaction. Skilled in process optimization and team mentorship, ensuring regulatory compliance and strong client relationships.
Overview
31
31
years of professional experience
Work History
Associate Director, CDM
Thermo Fisher Scientific
Austin, USA
07.2021 - Current
- Oversees data management processes, ensuring timelines and contracts are adhered to and quality standards are met for assigned projects.
- Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
- Ensures that DM tasks are clearly understood and completed in line with protocol, contract, GCP and SOPs/WPDs.
- Manages workload allocation and establishing priorities for assigned project teams; produce status reports for management and clients as required; and ensure the quality, efficiency, and timeliness of the work for assigned staff.
- Performs senior level customer communication/coordination.
- Develops and presents proposals in response to requests from potential customers and supports business development activities presenting data management strategy at bid defense meetings.
- Develops, implements, and tracks appropriate departmental performance metrics.
- Manages the resources and workload of direct reports with focus on achieving or exceeding utilization targets.
- Participates in the formation and implementation of the strategic development plans for data management.
- Promotes repeat business relationships with existing clients and is instrumental in bringing new data management business to the organization through BD activities.
- On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD.
SR CDM PM
Thermo Fisher Scientific
04.2020 - 07.2021
- Managed day-to-day operations for a group of data management projects or key functions. Performed the Project Management role for studies that do not have a clinical component or acted as Franchise Manager for allocated clients. Provided customer contract and functional, administrative, and financial oversight of assigned projects.
- Monitored entire project lifecycle to ensure smoothness (i.e. creation of electronic edit checks, development of DM Listings, DB go-live, 3rd party vendor data and SAE reconciliation, DB Lock, timelines etc.)
- Acted as the “Account” Manager/CDM Franchise Lead for a portfolio of projects from one or more clients to provide oversight and ensure all tasks are completed accurately, on time and within budget to meet or exceed client expectations.
- Acted as primary liaison for project team and client. Participated in internal or client meetings as needed.
- Oversaw risk management for projects/portfolios ensuring adherence to guidelines and process; provided ongoing support and guidance on assessment of project risks to the project members; provided/escalated high-level sharing of risks, concerns, and study success. Participated in business development meetings/activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required. Helped develop client relationships with oversight from management.
- Participated in the formation and implementation of strategic department development plans and initiatives.
- Oversaw, reviewed, approved study documents (e.g., DVM) with input from the internal/client teams.
- Ensured development and maintenance of Data Management project documentation files, (e.g. eTMF ongoing reviews) to maintain audit readiness, at all times.
- Ensured generation of reports study metrics per Sponsor requirement.
- Managed Third Party Vendors.
Group Manager, Clinical Data Management
Thermo Fisher Scientific
04.2018 - 03.2020
- Managed day-to-day operations for a group of data management projects or key functions as well as manage the project staff and workloads for direct reports. Performed the Project Management role for studies that do not have a clinical component or act as Franchise Manager for allocated clients, responsible for customer contact and functional, administrative, and financial oversight of assigned projects.
- Provided supervisory function for a group of allocated staff within the data management department including training and mentoring.
- Performed ongoing performance appraisals and supports staff development for direct reports, Supports HR and DM management with the hiring, discipline, and discharge of staff, as necessary.
- Acted as the senior contact for all aspects of data management for assigned projects. This included effectively liaising with clients, project team members and colleagues in other functional groups.
- Ensured staff compliance with documented procedures.
- Provided financial oversight for all projects, ensuring that out of scope activities are followed throughout the contract modification process until timely closure.
- Participated in business development activities including timely input to budgets and proposals for data management activities and presenting data management strategy at bid defense meetings.
- Assisted CDM senior management with the formation and implementation of strategic development plans and initiatives.
- PPD retired the Group Manager, CDM job title in March 2020 and staff with that job title were assigned to a new job title based on their current work assignments.
Manager, Data Operations
Kendle International, Inc.
Thousand Oaks, USA
10.2006 - 03.2020
- Managed the overall utilization, allocation and management of Clinical Data Managers and Clinical Data Associates.
- Managed the Clinical Data Management activities as related to study setup, initiation, development of case report forms and Electronic Data Capture Systems.
- Lead study level system requirements meetings with internal and external clients.
- Oversaw all timelines, quality, edit checks and budget on projects assigned to teams.
- Managed 50 global Clinical Data Management study staff members to insure the expert management of approximately 23 global studies.
Director, Operations
Vivometrics, Inc.
Ventura, USA
04.2005 - 07.2006
- Managed new and existing hardware development activities from concept through manufacturing.
- Designed and developed a non-invasive physiological ambulatory monitoring system for pre-clinical research.
- Managed Clinical Systems, Field Service Coordinators, Customer Service, and on-site installs to guarantee the highest quality of customer training and satisfaction.
- Managed the Distribution Center to ensure all Pharmaceutical Sponsors had an adequate supply chain to execute their designed protocols.
Director, Project Manager
Vivometrics, Inc.
03.2004 - 04.2005
- Acted as a technical project liaison with Regulatory, Quality Assurance, Product Development, and Data Management staff.
- Served as project leader on one or more project teams.
- Provided expertise and assistance in negotiating team issues.
- Identified issues and recommended improvements to resolve issues related to clinical trials, strategic planning, and implementation.
- Monitored clinical trials by means of management reports and/or MS Project to achieve successful protocol timelines.
Clinical Project Manager
Vivometrics, Inc.
06.2003 - 03.2004
- Developed and implemented client project plans for new clinical trials.
- Managed and maintained timelines on all clinical trial projects.
- Organized and tracked all aspects on contracts, including status of contracts, equipment/labor required and term dates.
- Coordinated communication between clients, sales, and legal department during contract negotiations.
- Tracked all project related time to submit for monthly billing.
Clinical Studies Supervisor
Quest Diagnostics, Inc.
Van Nuys, USA
04.2001 - 06.2003
- Planned, scheduled, and supervised the operational and personnel activities of the team to achieve accurate set-up and monitor clinical studies in accordance with defined global processes.
- Deployed team resources across projects; negotiating for additional resources as necessary.
- Ensured that service levels and resources from functional departments met process and timeline requirements.
- Provided technical expertise related to internal quality control process related to clinical studies.
Project Leader
Quest Diagnostics, Inc.
12.1994 - 04.2001
- Managed clinical trial protocols with approximate revenue of $10 million using technical and computer skills to satisfy the requirements of sponsors and investigators.
- Delivered protocol specific information resource requirements such a data transfers, specialized programming, data retrieval and billing.
- Designed study specific database elements unique to the protocol (e.g., phone alerts, blinding, test codes and editing criteria).
- Coordinated relationships between technical staff and sponsors on a global scale.
- Communicated daily with Business Development to provide the sponsors with the best service possible.
Education
Some College (No Degree) - Business Management
Moorpark College
Moorpark, CASkills
- Executive-level client support
- Financial oversight
- Sponsor relations
- Data management
- Project management
- Regulatory compliance
- Risk assessment
- Budget oversight
- Performance metrics
- Process optimization
- Business development
- Strategic leadership
References
References available upon request.
THERAPEUTIC EXPERIENCE AND EXPERTISE
- Circulatory: Heart failure, angina
- Dermatology: Skin Infections
- Digestive System: Gastroenterology
- Endocrine/Metabolic: Diabetes
- Hematology: Pyruvate Kinase Deficiency, Hemophilia B
- Infectious Disease: Gonorrhea; UTI; Influenza, Human, Coronavirus, Cytomegalovirus
- Musculoskeletal: Osteoporosis
- Oncology: Hepatocellular Carcinoma, Small cell tumors
- Vaccine: Coronvirus, EBV, CMV, RSV, Flu
ADDITIONAL RELEVANT EXPERIENCE
- Computer Experience
- Windows, MS Word, MS Excel, MS Project, Power BI and Power Query
- EDC: Medidata Rave, InForm and Veeva
Timeline
Associate Director, CDM
Thermo Fisher Scientific
07.2021 - Current
SR CDM PM
Thermo Fisher Scientific
04.2020 - 07.2021
Group Manager, Clinical Data Management
Thermo Fisher Scientific
04.2018 - 03.2020
Manager, Data Operations
Kendle International, Inc.
10.2006 - 03.2020
Director, Operations
Vivometrics, Inc.
04.2005 - 07.2006
Director, Project Manager
Vivometrics, Inc.
03.2004 - 04.2005
Clinical Project Manager
Vivometrics, Inc.
06.2003 - 03.2004
Clinical Studies Supervisor
Quest Diagnostics, Inc.
04.2001 - 06.2003
Project Leader
Quest Diagnostics, Inc.
12.1994 - 04.2001
Some College (No Degree) - Business Management
Moorpark College
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