University of Virginia

Norfolk Academy

Project Director at PRA Health Sciences

Raleigh, North Carolina, United States

- Global project oversight, mentoring of project managers and teams. • Manages project contractual deliverables: Supervises progress via metrics, monitors and ensuresadherence to the contractual agreement, and manages project costs• Acts as primary liaison and point of contact for client • Leads and directs cross-functional team leaders and third parties/vendors• Contributes to development, maintenance and approval of project plans• Guides and supports team leads in prioritizing, trouble-shooting and contingency planning• Communicates project specific priorities• Liaises with functional leads/managers to optimize performance and utilization of project teammembers• Leads presentation of internal project status reviews and is accountable for action item follow up.Proactively identifies, resolves/mitigates and escalates risks and/or issues• Assumes project leadership role in compliance at project level to PRA processes and systemsincluding escalation to relevant functional and operational management• Participation and attendance in bid defense process

PRA Health Sciences

Project Director

UPDATE: Thanks to the generosity of so many, I exceeded my $5,000 goal, and was thrilled to shave my head on 22Aug2017.  I am honored to stand in solidarity with the young boys and girls around the world who fight for their lives each and every day.  Donation link remains available if you'd like to contribute to this AMAZING cause!**Did you know that a child is diagnosed with cancer every 2 minutes?? **Less than 4% of federal cancer research dollars are spent on children's research. #4%isCriminal**Many of the childhood cancer drugs are over 30 years old!!So I decided to do something about it by raising money for cures. I shaved my head 6 years ago on a last minute whim, and raised almost $2,000.  So I'm putting the bar high this year with a goal of $5,000.This year I remember a sweet life lost to childhood cancer, and the strength and courage of two young men still fighting. Now I need your help! Will you make a donation? Every dollar makes a difference for the thousands of infants, children, teens, and young adults fighting childhood cancers.

St. Baldrick's Foundation

St. Baldrick's Shavee/Fundraiser

- Manages project contractual deliverables: Supervises progress via metrics, monitors and ensuresadherence to the contractual agreement, and manages project costs• Acts as primary liaison and point of contact for client • Leads and directs cross-functional team leaders and third parties/vendors• Contributes to development, maintenance and approval of project plans• Guides and supports team leads in prioritizing, trouble-shooting and contingency planning• Communicates project specific priorities• Liaises with functional leads/managers to optimize performance and utilization of project teammembers• Leads presentation of internal project status reviews and is accountable for action item follow up.Proactively identifies, resolves/mitigates and escalates risks and/or issues• Assumes project leadership role in compliance at project level to PRA processes and systemsincluding escalation to relevant functional and operational management• Participation and attendance in bid defense process

Senior Project Manager

- Oversight of a Phase III global clinical trial program with over 500 sites, in 44 countries•  Manages the executed contract and financial aspects of assigned projects  •  Reviews study budgets and expenses to ensure all study related contractual and budgeting issues are upheld and performed  •  Maintains effective communication with project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication  •  Performs ongoing review of project financial status of studies within his/her responsibility; alerts senior management to potential issues and ensuring necessary corrective action is taken  •  Oversees the regulatory document collection and submission process  •  Ensures project documentation, including Trial Master File, are complete and audit ready  •  Assists in the negotiation and contracting process with outside vendors such as laboratories, printers, drug packaging, labeling and storage, and Interactive Voice Response System companies•  Develops knowledge of current therapeutic environment  •  Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training•  Acts as a liaison and facilitator between other departments within the company to ensure project related tasks and/or issues are addressed

INC Research

Project Manager II

- Ensures the contracted services and expectations of a clinical study are carried out by the Company project team in accordance to the executed contract and the Customer’s expectations•  Manages the executed contract and financial aspects of assigned projects  •  Reviews study budgets and expenses to ensure all study related contractual and budgeting issues are upheld and performed  •  Maintains effective communication with project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication  •  Performs ongoing review of project financial status of studies within his/her responsibility; alerts senior management to potential issues and ensuring necessary corrective action is taken  •  Oversees the regulatory document collection and submission process  •  Ensures project documentation, including Trial Master File, are complete and audit ready  •  Assists in the negotiation and contracting process with outside vendors such as laboratories, printers, drug packaging, labeling and storage, and Interactive Voice Response System companies•  Develops knowledge of current therapeutic environment  •  Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training•  Acts as a liaison and facilitator between other departments within the company to ensure project related tasks and/or issues are addressed

Project Manager

- Primary management of Global Trial Master File (TMF) for large scale, multi-therapeutc sponsor program•	Assist senior management in the development, implementation and maintenance of processes and systems•	Develop and manage project budgets and resourcing of assigned study portfolio •	Develop and oversee Global TMF document processing and reporting systems•	Work to improve team metrics and other quality Key Performance Indicators (KPIs) through training, process improvement or other measures that seek to improve efficiency and quality •	Communicate metrics, KPIs and other relevant project status reports to team and departmental leadership•	Ensure metrics and protocol related deliverables for external and internal customers are met•	Work with Study Leader(s) to ensure study is being conducted and initiated according to study timelines•	Maintain effective communication with departmental leadership, individual project teams, and customers through oral and written communication, project status reports, and other progress reports as needed •	Serve as representative at customer meetings and leads internal departmental team meetings to review important project and process updates

Manager, Regulatory Records Management

- Line management responsibility for assigned Site Activation Specialists and Document Control Specialists•	Responsible for overseeing collection and approval of documents necessary for release of investigational product to sites•	Responsible for overseeing collection of investigator documents for U.S. and Canadian regulatory applications (initial and ongoing IND submissions and Health Canada CTA) and submission to sponsor regulatory groups•	Ensure metrics and protocol related deliverables for external and internal customers are met•	Manage project budgets and resourcing of assigned functional teams•	Works with Study Leader(s) to ensure study is being conducted and initiated according to study timelines•	Serves as representative at customer meetings and leads internal departmental team meetings to review important project and process updates

Associate Manager, Contracts and Functional Services

Lead recruiter for the Clinical Development, Quality Assurance, Programming, Biostatistics, and Regulatory Affairs groups within INC Research.  Responsible for the recruitment of CRAs, Project Managers, Project Research Associates, Regulatory Specialists, Regulatory Managers, GCP Auditors, Biostatisticians, Clinical Programmers and the like.

Recruiter

Sr. Technical Recruiter focusing on the clinical research and scientific fields.  While based in Raleigh, NC, I place candidates all across the country in contract, contract-to-perm, and direct-hire positions with our clients, the leading biotech and pharmaceutical companies, as well as the top CROs in the country.  We also work within the food and beverage, oil and gas, and other industries on the scientific side.

MISource

Sr. Recruiter

Clinical research recruiter for an international full service CRO.  Lead recruiter in the areas of Project Management, Medical Affairs, and Medical Writing; also heavily focused in the areas of Data Services, Executive Leadership, Drug Safety and Clinical Monitoring.

Kayla Klofenstine

Kayla Klofenstine