eCOA Project Manager
Join us as a Project Manager, where you will be responsible for directing and managing services for delivering the highest quality eCOA (eClinical Outcomes Assessment) software & service with on-time delivery.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.
In this role you will:
Lead the Planning and Setup, Monitoring, and Closeout phases of eCOA Clinical Trials/Study management which include:
- Gathering customer requirements and relaying to internal teams (including software development teams)
- Developing study documentation
- Distributing/tracking equipment
- Creating/distributing reports
- Archiving study data and documentation
- Appropriately setting and fulfilling of customer expectations
Monitor eCOA study timelines and manage the financial components of each study, which include:
- Budget reviews
- Revenue forecasting
- Scope changes
- Invoice reconciliation
- Identify potential study risks and mitigations, and escalate as appropriate.
- Manage internal/external negotiations and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations.
- Apply problem solving strategies to address customer issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to customer escalations.
- Ensure compliance with timely training completion/documentation.
- Present study services at Investigator Meetings or site initiation meetings as needed.
- Attend client meetings with Business Development and/or Operational teams to present Company services and Operational Data flow, as needed.
- Assist with training new members of the Project Management team.
- Perform other duties, assignments, or special projects as time and/or circumstances necessitate.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
Qualified candidates will have:
- Bachelor Degree and/or proven demonstrated Project Management skills or experience
- At least 4 years of project management experience, preferred within the Clinical Trial, Telecom or SW Development industry (or similar industry experience)
- Excellent organizational, interpersonal, time management, and prioritization skills
- Excellent verbal and written communication skills, including ability to communicate effectively in English
- Working knowledge of Microsoft Office products and strong technical aptitude
- Knowledge of the pharmaceutical drug development process and/or software development process very helpful
- Detail oriented and demonstrated responsiveness to inquiries and requests
- Valid passport and ability for travel of (up to) approximately 20%
ERT is a growing and rewarding place to advance your career, especially for those who are passionate about finding solutions that improve lives – or save lives – for millions of people around the world. Our success starts with caring and collaborative people, from the recent college grad who’s just getting started to the seasoned professional with a wealth of knowledge, skills and experience. Together, we’re making a difference.
ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.