Nicholas Jeffers
Wilmington,DE
Overview
11
11
years of professional experience
Work History
Global Site Activation Manager
IQVIA
Durham, NC
03.2023 - Current
- Efficiently manage and successfully execute all aspects of a global startup.
- Lead the execution of projects and initiatives related to the activation of new clinical research sites.
- Develop and maintain strong relationships with internal and external stakeholders.
- Monitor project timelines and milestones to ensure that they are met.
- Manage and coordinate the activities of research site personnel to ensure compliance with all applicable regulations and guidelines.
- Provide regular updates on project progress to internal and external stakeholders.
- Monitor site performance and progress, and provide recommendations for improvement.
- Utilize appropriate project management tools and techniques to ensure the successful completion of projects.
- Ensure that all research sites adhere to IQVIA's standard operating procedures.
- Assist in the development of training and educational materials for research site personnel.
- Identify and analyze potential challenges and risks related to the activation process.
- Enforced customer service standards and resolved customer problems to uphold quality service.
- Trained employees on additional job positions to maintain coverage of roles.
- Delegated work to staff, setting priorities and goals.
- Established processes to ensure efficient workflow throughout the organization.
- Established and monitored KPIs to evaluate performance and identify areas for improvement.
- Ensured compliance with all applicable laws, regulations, industry standards.
Associate Manager Clinical Operations and Development
Sage Therapeutics
Cambridge, MA
01.2023 - 09.2023
- Efficiently manage and successfully execute all aspects of a global startup.
- Review pertinent regulations to develop proactive solutions to startup issues and challenges.
- Define the development and delivery of the global study startup project plan by partnering with the CRO Study Startup.
- Lead a team of four individuals to oversee study start-up on a program level, serving as line manager.
- Oversee the analysis of clinical trial data and its application to conduct accurate study startup forecasts.
- Drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios, and accurate planning.
- Develop creative processes, methodologies, data, and technologies to ensure the ongoing delivery of valued Study Start-Up Services.
- Establish, develop, and deliver the Global Study Start-Up Project Plan.
- Provide guidance, oversight, and training to the Study Start-Up team, delivering activities to support clinical programs, including data and methodologies for protocol study start-up, country and site selection, study start-up planning, and modeling.
- Ensure standards are applied to the study start-up process across project portfolios, and support continuous improvement activities while developing TA-aligned strategies.
- Guide the collection and analysis of all data to influence study startup timelines.
- Lead the Site Activation team, including internal members and CRO, using the appropriate team members to help implement the Start-Up Project Plan.
- Help study teams conduct and provide ongoing delivery within timelines that contribute to operational planning and decisions, resulting in predictable delivery for achieving R&D goals.
- Liaise with clinical site staff and investigators, as appropriate, to ensure optimal sponsor-site relationships.
- Support the authoring of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), and other clinical documents as necessary.
- Partner with CMC/clinical supplies to provide drug supply assumptions.
- Manage all aspects of study progress, from planning to closeout, to assure adherence to intended timelines and achievement of study goals, while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
Start-Up Team Manager
PPD
Wilmington, NC
09.2021 - 01.2023
- Lead, execute, and achieve site activation and amendment deliverables globally.
- Coordinate and lead the project team through the process of activations of sites within the regional, global, and site levels.
- Works within the Start-up team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets, with accountability to Global Project Management.
- Collaborates with multiple start-up team members in a matrix environment for the effective delivery of site activation on assigned studies, according to timelines and quality standards.
- Lead efforts on regulatory submissions on a global level, and coordinate efforts between the departments.
- Participates with functional area leads to identify and evaluate fundamental issues pertaining to successful site activation, interprets data on complex issues, makes good business decisions, and ensures solutions are implemented.
E-5 Combat Medic
US Army Reserves
Horsham, USA
04.2014 - 04.2022
- Management of a squad of 8 medics tasking them to medical details across the eastern coast
- Coordination of training across a brigade of over 100 personnel
- Supervision of medical events conducting blood draws, vaccinations and physicals
- Medical Training Course Supervisor, teaching brigade staff as well as medical staff on basic first aid and CPR
- Maintain Health and Physical readiness and give reports to higher ups inside chain of command
- Assist in classes regarding health such as first aid and suicide awareness
- Regularly act as line medic for events where medical support is needed
- Maintaining all unit medical records and advise appointments to those who are past due in medical appointments
- Maintain a certification as an EMT-B
- 300+ hours Instructing First Aid, Combat Lifesaving Courses, and EMT recertification courses
Site Activation Lead
ICON PLC
North Wales, PA
09.2020 - 09.2021
- Oversees day to day delivery of all aspects of site activation in the projects assigned
- Ensure adequate oversight of the project in terms of timely delivery of key timelines and that the impact of missed deliverables is understood by all key stakeholders
- Creates and maintains an environment of 'trusted partner' which allows successful delivery of site activation through clear and open dialogue and use of 'best practice' communication
- Support sales preparation materials and calls including bid-defense and study kick-off meetings where required
- Manages and escalates any significant variations to study budgets, identifies out of scope activities and ensures to input into change orders as required
- Maintain relationships with sites and PI's to ensure a positive working relationship over course of the study and other projects ongoing
- Works closely with peers to ensure global consistency in the successful execution of site activation activities & services across the SSU function
- Attending client meetings, such as bid defenses, kick off meetings, investigator meetings, and client teleconferences
- Remote
Contract Site Activation Team Specialist
AstraZeneca
Wilmington, DE
12.2019 - 09.2020
- Management of study start-up activities, working directly with study managers and clinical research monitors, to ensure timely delivery of all site activations.
- Informed Consent Form creation, customization, and review.
- Obtain and maintain essential documentation in compliance with ICH-GCP and AZ procedural documents.
- Assist in the coordination and administration of clinical studies from start-up through site activation.
- Activate study sites in compliance with AZ Procedural Documents.
- Updating IMPACT/Veeva Clinical Vault and other systems with data from centers as required per SAT process.
- Creating and importing clinical-regulatory documents into a global electronic library, ensuring compliance with AZ procedures to support publishing.
- Contribute to the creation of study start-up documents.
- Ensuring the timely delivery of proper documents for the support of the study team's submission to regulatory authorities.
- Prepare for activities related to audits and regulatory inspections in liaison with the Local Study Delivery Team Lead and QA.
Clinical Trial Specialist
PRA Health Sciences
Blue Bell, USA
08.2018 - 12.2019
- Oversight of Study Start-up and maintenance of clinical studies with ranging indications
- Extensive site contact within sponsors desired timelines
- Remote Monitoring of sites to include recruitment, opening queries to sites and closing follow-up items
- Meeting timelines for deliverables for Sponsor companies
- Assistance on queries from sites on Protocol related issues
- Peer Mentoring of newly hired employees
- Flexibility with variances in Sponsor required deliverables
- Team Management and updating project team of appropriate deviations
- Filing and control of all documents into the Trial Master File
- Consistent updates to the CTMS/PSO systems for quality accuracy
- Review of informed consent form and approvals with edits
- Meeting timelines on deliverables for sponsor companies
- Ensuring IRB submissions are completed and approved within timelines
- Quality control checks for TMF completeness and accuracy
- Peer Mentoring of newly hired Employees
- Blue Bell, PA
Education
Bachelor of Science - Biological Sciences
Rowan University
Glassboro, NJ05.2018
Skills
- Clinical Trial Management Systems
- Data Analytics Systems
- Electronic Trial Master File
- Microsoft Office
- Regulatory compliance
- Performance management
- Cross-functional team management
- Risk management
- Vendor management
- Clinical Monitoring
- Site Engagement
- Patient Recruitment
Therapeutic Experience
- Ophthalmology
- Oncology
- Neurology
- Psychiatry
- Immunology
- Cardiovascular
Timeline
Global Site Activation Manager
IQVIA
03.2023 - Current
Associate Manager Clinical Operations and Development
Sage Therapeutics
01.2023 - 09.2023
Start-Up Team Manager
PPD
09.2021 - 01.2023
Site Activation Lead
ICON PLC
09.2020 - 09.2021
Contract Site Activation Team Specialist
AstraZeneca
12.2019 - 09.2020
Clinical Trial Specialist
PRA Health Sciences
08.2018 - 12.2019
E-5 Combat Medic
US Army Reserves
04.2014 - 04.2022
Bachelor of Science - Biological Sciences
Rowan University