ERT - Cleveland/St. Louis is hiring a Manager, Project Management! This management position will be responsible for directing and managing multiple projects and serving as a subject matter expert for client projects to assure high quality, on-time, and on-budget services while promoting excellent client service.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it 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. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning 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. For more information, go to ert.com or follow us on LinkedIn, Twitter, and Facebook.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Perform and lead the Planning and Setup, Monitoring, and Closeout phases of study management which include: a. Gathering customer requirements and relaying to internal teams b. Ensuring the on time development of the study documentation as defined in SOP or SWI, contributing and supporting as designated. c. Coordination of the various teams working in support of the Study (ex: Image QC, Site and Reader Management, etc.) d. Creating/distributing reports e. Archiving study data and documentation f. Appropriately setting and fulfilling customer expectations
2. Execute and monitor study timelines and manage the financial components of each study, which include: a. Budget reviews b. Revenue forecasting c. Scope changes d. Invoice reconciliation
3. Identify potential study risks and mitigations, and escalate as appropriate.
4. Manage internal/external dialogue and promote collaboration to foster a positive team environment, effective communications, and efficient use of resources to meet study timelines and contractual obligations.
5. Develop and apply problem solving strategies to address client issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations.
6. Serve as PM point of contact for operational readiness regarding new product initiatives when assigned.
OTHER DUTIES AND RESPONSIBILITIES:
1. Read, comprehend and be able to summarize various study documents (i.e. Clinical Protocol, contracting documents, budget, Imaging Charter) to understand and communicate the role of imaging within the assigned studies.
2. Provide accurate and detailed project time reports, complete assignments within prescribed and committed timelines, seeking assistance and support when necessary.
3. Ensure compliance with timely training completion/documentation.
4. Create content and present at Investigator Meetings, site initiation or other meetings as needed.
5. Attend client meetings with Business Development and/or Operational teams to present Company services and Operational Data flow, as needed and participate in sales initiatives to generate incremental revenue
6. Assist with training new members of the Project team.
7. Other related assignments, projects and tasks as assigned.
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. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.
QUALIFICATIONS AND SKILLS NEEDED:
1. Bachelor Degree and/or proven demonstrated Project Management skills or experience within the industry, including expertise in primary service line and/or support of studies in multiple service lines
2. Minimum 3-5 years of experience in project management and or project leadership experience with additional experience preferred in the workflows within one or more of: clinical trial management, healthcare management/operations, pre-clinical research, radiologic or a related science.
3. Excellent organizational, interpersonal, time management, and prioritization skills
4. Excellent verbal and written communication skills, including the ability to communicate effectively in English
5. Must be computer literate with application knowledge of Microsoft Word, Excel, PowerPoint, database querying, e-mail and electronic calendar.
6. Detail oriented and demonstrated responsiveness to inquiries and requests.
7. Understanding of risk management and the ability to identify potential problems, escalate and assist in resolution as needed.
8. Understanding of work in a regulated industry, preferably within pharmaceutical, medical device or medical imaging.
9. Excellent communication and organizational skills with a strong ability to collaborate in English with teams of research scientists, bioinformaticians, software developers, and external collaborators. Will have frequent interaction with clients, sites, management and staff.
10. Must have a valid passport and the ability to travel approximately 20%.
The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.