Project Delivery Lead

Velocity Clinical Research, Inc.•Durham, NC

22h

About The Position

This position is responsible for global planning and execution of the study-specific approaches toward delivering across all participating Velocity sites for the entire project life cycle of assigned projects and customer relationships. The PDL operates in a matrix environment, collaborating across central patient recruitment, marketing, start up, regulatory and operations functions as well as individual site teams, and external vendors. The PDL may also support business development in select opportunities toward earning new work. The PDL directs the technical and operational aspects of the project, establishes measurable goals, monitors progress, and adjusts the strategy and delivery to meet or exceed sponsor expectations and commitments, and directs the work of stakeholders in a matrix environment. The PDL must have a comprehensive knowledge of and attention to study startup, patient screening and enrollment, patient retention, data collection, protocol compliance, key sponsor milestones and achievement, and study closeout. The PDL will represent Velocity as the single point of contact across sites and functions for project delivery, communicating directly with the project team stakeholders and leaders internally and with sponsors, CROs and vendors to ensure that project targets are met and that the services provided with the highest quality standards, consistent with all company policies and procedures.

Requirements

Expertise in strategic planning, project management, clinical site management with extensive knowledge of clinical research process and patient recruitment
Strong communication and presentation skills
Ability to organize and operationalize strategic plans combined with technical skills to track, summarize and report detailed information.
Problem-solving and strategic decision-making ability
Adaptability to monitor and adjust plan toward meeting and exceeding goals,
In-depth knowledge and application of GCP, FDA and ICH guidelines
Proficient in Microsoft Word suite (Word, Excel, and PowerPoint), email, and voicemail,
Advanced ability to work independently, plan and prioritize multiple deliverables and objectives
Bachelor’s degree preferred or combination of education and experience.
4+ years of clinical research experience including patient recruitment, site management and/or project management experience, along with evidence of leadership abilities.
Experience with or comfort in directing work in a matrix environment

Responsibilities

Develop and establish regular and impactful communications with critical stakeholders around the program start up process, post launch and program performance for the life of the study here at Velocity.
Seek to identify and establish relationships with customer peers in project delivery and clinical operations roles (Sponsors and CROs), outside day-to-day site level relationships with clinical research associates or equivalents.
Collaborate cross-functionally across all regions and countries to develop a study specific delivery plan at the start of every study and manage that plan through to completion.
Study details-collaborate with clinical operations and medical teams to understand study protocols, patient pathways and profiles, inclusion/exclusion criteria and enrollment goals
Recruitment challenges/potential barrier-Identify and address critical patient and site burden areas, recommend recruitment tactics
Establish study specific KPIs to drive study performance and delivery
Proactively plan and measure startup milestone and patient recruitment to ensure that study timelines are met
Manage patent recruitment vendors and ensure that they are used to driving recruitment and support the success of the study
Ensure that EDC data entry is completed in a timeline that corresponds to the commitments that we have made to the sponsor/CRO
Understand customer success measures and gain access to tracking systems, reporting, etc. used to measure Velocity performance
Monitor achievements across Velocity sites and among other sites to share success examples across sites, and to identify sites that require intervention
Escalate and advise when studies are off track and/or not enrolling; identify and implement mitigations to get back on track.
Support the sponsor/CRO in day-to-day query resolution
Monitor internal systems and reports to ensure compliance.
Gain access to sponsor, CRO, and vendor systems necessary to fully manage project
Act as an ambassador for Velocity-developed technologies and/or partnered services. Seek ways to increase efficiency and participant engagement through technology and process improvement. Collect and provide constructive internal feedback for the advancement of Velocity technology platforms
Gain alignment with the site and operations stakeholders on recruitment plan implementation and feedback loop.
Develop and maintain relationships with Customers in alignment with their assigned project/therapeutic area/sponsor.
Act as a project level SME for delivery and be the main point of escalation for both sponsor and CRO.
Drive strategic decision-making cross-functionally to recommend optimizations and create the best path forward for study delivery.
Support the BD as needed in the pursuit of winning new business and adding new sites.
Ensure all third-party vendors are established in conjunction with the site leader to ensure on time study start; break down perceived barriers that might exist in finding vendors.