Clinical Project Manager, Digital Trial Solutions

Tech Cambridge, Massachusetts Cambridge, MA Raleigh-Durham, North Carolina Plymouth Meeting, Pennsylvania


Description

Position at ConcertAI

Company Overview

ConcertAI’s mission is to accelerate insights, advance research, and improve patient outcomes in oncology and across life sciences. ConcertAI’s leading real-world evidence, AI technology and software-as-a-service solutions support healthcare decision-making across clinical research & development through commercialization. Top biopharma sponsors, clinical research organizations, healthcare providers and institutions rely on ConcertAI’s evidence-generation and digital transformation capabilities to advance precision medicine and medical innovation.

 

ConcertAI has emerged as one of the fastest growing AI health tech companies backed by industry-leading private equity companies: SymphonyAI Group, Declaration Partners, Maverick Ventures, and AllianceBernstein PCI.

 

Role Summary

This role is an important member of the Digital Trial Solutions team. The Project Manager leads design, implementation, and ongoing management of all project management efforts across a portfolio of Sponsors, Sites, third party Vendors and Clinical Trial Studies assigned to him/her.

 

Responsibilities

  • Own, develop and communicate project management processes across the Clinical Trial Solutions portfolio, educating ConcertAI, Vendors, Sponsors and Sites of the approaches and expectations of each party.
  • Develop and maintain clinical project management and communication plans in conjunction with Vendors, Partners, Sponsors and Sites and be the key driver for Trial Study startup, training, trial run/support and study close out activities.
  • Lead, collaborate and coordinate with ConcertAI Delivery team, third party Vendor teams, Sponsor team and Site teams to ensure study timelines are met, budget constraints are within guidelines and motivation for all parties to successfully complete the study run.
  • Comprehensively track and manage assigned Trial Studies and associated metrics, working to improve Trial Study run time economics and efficiencies.
  • Serve as ConcertAI liaison with Sponsors, Sites, Vendors and Partners facilitating progress and growth through ongoing communications, engaging leadership when appropriate to support decision-making and next steps.
  • Collaborate with the Clinical Trial Solutions team to understand Sponsor/Site/Trial Study specific needs, goals and develop plans to implement the solution.
  • Drive all relevant Study meeting preparation in collaboration with the Clinical Trial Solution team, including draft agenda development, presentation materials development and meeting scheduling.
  • Manage and track project billing activities, financial milestones and payments, ensuring payments are resolved in a timely fashion.
  • Responsible for regulatory and audit-readiness for assigned projects and client portfolios, working interdepartmentally to support regular and for-cause audits and audit responses consistent with contracted deadlines.
  • Maintain trial data and informational repositories consistent with established process, inclusive of trial data archive and final document delivery to clients at study closeout.
  • Project Management duties include risk planning & mitigations, issue communication & resolution, maintaining RACI’s, maintaining financials, change management and release management communications.

Requirements

  • Bachelor’s degree education.
  • 3-5 years’ experience working on clinical trials. Oncology-specific experience is strongly preferred.
  • 2-4 years of experience in managing projects or clinical trials.
  • Familiarity with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
  • Highly proficient with MS Office, project management software.
  • Effective problem-solving skills with a demonstrated ability to identify and quickly resolve issues.
  • Excellent written and verbal communication, presentation, and people management skills.
  • Experience in analyzing and interpreting processes, costs of care, revenue, and annual budgets.
  • Able to work successfully in a diverse team environment. 

 

Learn More About ConcertAI

Our team at ConcertAI is dedicated to transforming healthcare decision-making through the application of RWE and AI to improve patient outcomes. We work in a fast-paced, dynamic, high-performing culture where diversity, collaboration, and innovation are valued. Join us on our quest to create a world free of disease. Learn more about ConcertAI at www.concertai.com, or follow us on LinkedIn. 

 

EEO

ConcertAI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.