Susan Studley
Warwick,R.I.
Summary
Accomplished at clinical trial management including extensive experience as a study coordinator at an academic facility including staff resourcing and management of site staff, Clinical Research Associate, Clinical Oversight Lead, Project Management, and Study Manager. Strong protocol writing skills, with the ability to solve site problems, co-chair the study team, as well as being influential in providing insight to the team for monitoring issues throughout the life of the clinical trial. Strong background in assisting with site/country feasibility activities and discussions, activities/projections related to enrollment planning, and recruitment strategies. Extensive clinical background as an RN, MSN. Core Qualifications: Protocol and ICD Writing Publication Critical Thinking Research Goal setting and Implementation Communication Skills Problem Solving Administrative Management Risk Assessment and Mitigation. Accomplishments: Implemented new work process flow which increased department productivity as the Director of Clinical Research at an academic facility. This was accomplished by exploring best practices in clinical research and implementing these practices. Goal-oriented Team Manager dedicated to meeting team performance objectives and achieving set targets. Offering 29 years of extensive leadership experience in the pharmaceutical industry. Committed individual well-versed in providing thorough training, setting team goals and developing innovative strategies. Superb oral and written communication skills paired with excellent time management and leadership abilities.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior Clinical Team Manager
Synteract
Morrisville, NC, United States
10.2021 - Current
- Developed and updated policies and procedures, maintaining compliance with statutory, regulatory and local, state and federal guidelines relating to ICH-GCP guidelines.
- Adhered to study timelines to meet expectations of study sponsor and other stakeholders.
Team Manager
ICON
Remote, Rhode Isl
04.2021 - 09.2021
- (CTM) provides operational expertise and leadership in the planning, implementation and management of clinical trials through all periods of trial conduct
- The Senior CTM is responsible for quality and ‘on time’ delivery of clinical deliverables
- All activities are conducted in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, applicable regulations, rules and guidance
- Evaluated employee performance on [Timeframe] basis and coached and trained [Number] team members, increasing quality of work and employee motivation.
Project Manager
DOCS Global, Sanofi CNS
Boston, MA
03.2020 - 04.2021
- Responsible for conducting feasibility and study start up
- Ensures that clinical trials are carried out within timelines and budgets, and in accordance with ICH-GCP guidelines and global and local standard operating procedures
- Additional activities may include fostering and development of the monitoring program and /or facilitating the objectives of the clinical project teams
- Oversee the training, mentoring, and supervision of CRAs including where required co-monitoring and audit preparation of sites.
- Identified plans and resources required to meet project goals and objectives.
Senior Clinical Operations Lead
Synteract
Morrisville, NC, NC
04.2018 - 03.2020
- Clinical Operations Lead - Oncology
- Ensure quality of the clinical monitoring and site management deliverables within a project and/or program and maintain proper visibility of its progress
- Interact with the client and other functional departments related to clinical monitoring and site management activities and deliverables
- Participate in business development activities
- As required, provides development and delivery of initial and ongoing training to the study team
- Plans and leads regular clinical project team calls to provide status updates, ongoing training and accountability to deliverables
- Evaluate staff’s competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process
- Coaches and mentors COLs regarding functional clinical delivery, evaluation of project risks, and action implementation
- Globally reviews Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Strategic Data Monitoring (SDM) and/or other dashboards to oversee site and project team conduct
- Reviews the content and quality of site monitoring documentation
- Ensures deliverables are provided according to company and/or sponsor specifications, including delivery deadlines
- Understands the monitoring strategy required for the project and, where required, participates in the development of the project risk assessment plan
- Is accountable for the clinical teams’ understanding, ongoing compliance and delivery, according to the stated monitoring strategy, CMP/SMP, and risk plans Collaborates with other functional areas to ensure site compliance and delivery according to protocol, ICH/GCP medical monitoring, Safety and Quality Assurance (QA)
- Ensures Inspection Readiness for Clinical Scope
- Drives and manages the clinical and site management aspects of assigned project
- Ensure alignment of clinical activities to budget, including identification of out-of-scope activities
- Oversees the global project process and status of monitoring and data flow
- Reviews status and trends at the study level
- Proactively collaborates with data management functional lead to plan towards data cut and lock deadlines
- Develops and executes corrective action plans at study (global) level to address any issues.
- Trained new employees on proper protocols and customer service standards.
Takeda Senior Clinical Study Manager
PRA Partnership, Takeda Pharmaceuticals International Co
05.2017 - 01.2018
- Includes leading and organizing cross functional study team meetings
- Responsible for communication of study information to Clinical Operations regions
- Contributed to protocol synopsis development and to Clinical Study Plan development, including Clinical Operations feasibility assessments
- Lead the cross functional protocol development process, including responsibility for any protocol amendments or administrative changes
- Managed Strategic Partners, including setting expectations, training, CRO Oversight process, Task Orders, Change Orders, invoice approval and financial reconciliation process for assigned study
- Lead the evaluation and selection of required vendors, including contract and budget negotiation, invoice approval and financial reconciliation process
- Provided management of vendors
- Provided Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply
- Escalated medical issues to appropriate medical personnel
- Provided regular budget updates to Clinical Program Manager, or Finance when required
- Identified risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Assist Clinical Program Manager and may represent Clinical Program Manager, Regional Clinical Site Manager II, Associate Director, Compliance Oversight Lead
Pfizer, Inc
03.2011 - 04.2017
- Oversight of site management, vendor monitoring, feasibility, site selection, study start-up and study conduct until study closure
- Provided Clinical / Medical / Scientific support to sites to ensure patient safety and addressed safety issues at site level Supported patient eligibility process
- Monitored site performance metrics, visits site to ensure compliance, resolved issues and shared insights across sites and studies Supported sites and CRAs
- Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
Lead Clinical Research Associate Study Manager
Kforce, Inc
10.2005 - 03.2011
- Facilitated communication between study teams, CRA's and site personnel as appropriate Provided pre-trial assessment training to assigned CRAs and oversight of study start- up efforts including site selection
- Conducted pre-trial visit assessments, assisted with Investigator Meeting and agenda content Provided therapeutic and protocol training
- Served as primary point of contact for assigned CRAs Focused on recruitment strategy and oversight of data compliance Coordinated study conducts and end of study efforts
- Assisted in preparation for future related protocols
Clinical Research Associate
Pfizer Global Research and Development CNS
07.2001 - 07.2002
- Coordinated and attended study start up team meetings Participated in the development of clinical trials Collaborated with sponsor project team
- Adhered to critical timeline requirements Participated in CRF design/development Met and collaborated with appropriate vendors Conducted site selection, site initiation and interim monitoring visits Prepared/reviewed ICD templates Reviewed site-initiated advertisement for content/ accuracy Responsible for query resolution review of study related data; lab values/ adverse event tracking
Education
Nursing, BSN - Nursing
Salve Regina University
Newport, RIMaster of Science - Nursing
University of Phoenix
2008
Skills
- Team Management Understanding
- Scheduling and Coordinating
- Continuous Improvement Projects
- Managing Operations and Efficiency
- Administration and Reporting
- Team Meetings
- Corrective Actions
- Status Updates
Accomplishments
- Sigma Theta Tau
- (Membership by invitation only) International - Omicron Delta Chapter, 2009 –, Roger Williams Medical Center IRB 1996- 2004
Certification
EDC Experience: Rave, OC/RDC, Inform
GCP Training: CITI February 2020
Additional Information
- Nursing License # 20707 Rhode Island
Timeline
Senior Clinical Team Manager
Synteract
10.2021 - Current
Team Manager
ICON
04.2021 - 09.2021
Project Manager
DOCS Global, Sanofi CNS
03.2020 - 04.2021
Senior Clinical Operations Lead
Synteract
04.2018 - 03.2020
Takeda Senior Clinical Study Manager
PRA Partnership, Takeda Pharmaceuticals International Co
05.2017 - 01.2018
Assist Clinical Program Manager and may represent Clinical Program Manager, Regional Clinical Site Manager II, Associate Director, Compliance Oversight Lead
Pfizer, Inc
03.2011 - 04.2017
Lead Clinical Research Associate Study Manager
Kforce, Inc
10.2005 - 03.2011
Clinical Research Associate
Pfizer Global Research and Development CNS
07.2001 - 07.2002
Nursing, BSN - Nursing
Salve Regina University
Master of Science - Nursing
University of Phoenix